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National Clinical Guideline Centre (UK). Stroke Rehabilitation: Long Term Rehabilitation After Stroke [Internet]. London: Royal College of Physicians (UK); 2013 May 23. (NICE Clinical Guidelines, No. 162.)
Weakness is common after stroke; this may arise due to the upper motor neuron lesion compounded by inactivity as a consequence of limited physical mobility. Weakness limits patients’ ability to move the body, including changing body position, transferring from one place to another, and walking as well as upper limb functions such as carrying, moving or manipulating objects. It also limits performance of activities of daily living and may lead to a more generalised loss of fitness.
The ability to walk following a stroke is often affected or lost due to multiple and complex deficits of motor and sensory systems giving rise to loss of movement, balance and postural control. Rehabilitation of gait ideally attempts to restore a normal walking pattern or if this is not possible to develop a compensatory approach using various aids to promote a safe and functional level of mobility. The ability to walk following a stroke is often seen by both the patient with stroke and their team as a major desirable outcome at any stage throughout the rehabilitation journey and significant time and effort is often required by the patient and their team in order to re-educate gait and promote independent mobility.
Maximising upper limb recovery after stroke similarly requires significant time and effort by the patient after stroke and the rehabilitation team. It has been estimated that upper limb paralysis affects one third of the stroke population. The site and size of the lesion is a major determinant of outcome, with some people after stroke having such severe loss that no amount of therapy will affect functional recovery. However, a significant proportion of people following stroke will regain good arm function through spontaneous recovery. In the remainder, additional therapy may improve outcomes.
Many of the techniques used to support the patient in relearning motor skills depend on repetitive task practice. Repetitive task training encompasses a number of ideas; firstly that repetitive practice early after stroke may lead to beneficial neuroplastic changes within the brain; secondly that repetitive practice reduces weakness; thirdly, that complex movements can be broken down into their components allowing practice of simple elements before incorporating the entire movement; fourthly, that varying task complexity and training schedules (distributed practice, contextual interference) promotes motor learning and generalisation to real life situations and retention of skills; and fifthly that feedback is critical to learning the motor skills.
In addition strength training can be used to address the secondary muscle weakness that arises as a result of inactivity. The underlying mechanisms of neuromuscular weakness after stroke possibly include atrophy of type II fibers, increased proportion of type I fibers, loss of motor units, collateral reinnervation, and altered firing of motor unit groups. It is thought that remodelling of motor units occurs in the months after stroke and it may be possible to enhance this process with therapies directed toward increasing muscle strength and thus functional ability.
In practice the distinction between strength training and repetitive task practice may be less clear, for example, treadmill training with body weight support may be used to facilitate a better gait pattern while building strength and endurance.
13.1. Strength training
Decreased muscle power is common after stroke; this may be due to compromised muscle function post-stroke, compounded by inactivity as a consequence of limited physical mobility. Decreased muscle power limits patients’ abilities in activities of daily living and may lead to a more generalised loss of fitness.
Strength training through repetitive practice may represent one approach to improving upper and lower function after stroke.
13.1.1. Evidence review: In people after stroke what is the clinical and cost effectiveness of strength training versus usual care on improving function and reducing disability?
| Clinical Methodological Introduction | |
|---|---|
| Population | Adults and young people 16 or older who have had a stroke |
| Intervention |
|
| Comparison | Usual care |
| Outcomes | Upper Limb
|
13.1.1.1. Clinical Evidence Review
Searches were conducted for systematic reviews and RCTs comparing the clinical effectiveness of strength training with usual care to improve function and reduce disability for adults and young people 16 or older who have had a stroke. Only studies with a minimum sample size of 20 participants (10 in each arm) were selected. Nine RCTs were identified.
Table 84 summarises the population, intervention, comparison and outcomes for each of the studies.
Table 84
Summary of studies included in the clinical evidence review. For full details of the extraction please see Appendix H.
Comparison: Functional strength training (upper, lower limb) versus usual care
Table 85
Upper limb functional strength training usual care - Clinical study characteristics and clinical summary of findings.
Comparison: lower limb functional strength training versus usual care
Table 86
Lower limb functional strength training versus usual care – Clinical study characteristics and clinical summary of findings.
Comparison: Resistance training versus usual care
Table 87
Resistance training versus usual care - Clinical study characteristics and clinical summary of findings.
Comparison: Family mediated exercise intervention versus usual care (physiotherapy)
Table 88
GRADE characteristics and clinical summary of findings.
13.1.1.2. Economic evidence
Literature review
No relevant economic evaluations comparing strength training with usual care were identified.
Intervention costs
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
The cost of providing strength training (Table 89) was estimated based on the resources used in two studies (Flansbjer, 200884 and Cooke, 201047) included in the clinical review. The remaining studies included in the clinical review68,142,178,285 were not used as they did not provide sufficient information about the type or amount of resources used.
Table 89
Intervention costs – muscle power training.
These estimates represent the cost of muscle power training provided by NHS or PSS staff in the early phase after stroke. However, in later stages, strength training may be handed over to an appropriately qualified gym instructor and this would have lower costs.
13.1.1.3. Evidence statements
Clinical evidence statements
One study142 of 75 participants found no significant difference in Barthel Index between those participants who received upper limb functional training and those who received usual care at a follow-up of 6 months (LOW CONFIDENCE IN EFFECT).
One study142 of 75 participants found no significant difference in grip strength (paretic hand) between those participants who received upper limb functional training and those who received usual care at a follow-up of 6 months (MODERATE CONFIDENCE IN EFFECT
One study142 of 75 participants found that there was no significant difference in grip strength (non-paretic hand) between those participants who received upper limb functional training and those who received usual care at a follow-up of 6 months (LOW CONFIDENCE IN EFFECT).
One study142 of 75 participants found no significant difference in Barthel Index between those participants who received upper limb functional training and those who received usual care at a follow-up of 1 year (VERY LOW CONFIDENCE IN EFFECT).
One study142 of 75 participants found no significant difference in grip strength (paretic hand) between those participants who received upper limb functional training and those who received usual care at a follow-up of 1 year (LOW CONFIDENCE IN EFFECT).
One study142 of 75 participants found no significant difference in grip strength (non-paretic hand) between those participants who received upper limb functional training and those who received usual care at a follow-up of 1 year (LOW CONFIDENCE IN EFFECT).
One study68 of 20 participants found no significant difference in Action Research Arm Test (ARAT) between those participants who received upper limb functional training and those who received usual care at 3 months follow-up (LOW CONFIDENCE IN EFFECT)
One study68 of 20 participants found that there was no significant difference in Grip force (N) between those participants who received upper limb functional training and those who received usual care at 3 months follow-up (LOW CONFIDENCE IN EFFECT).
One study68 of 20 participants found that there was no significant difference in pinch force (N) between those participants who received upper limb functional training and those who received usual care at 3 months follow-up (LOW CONFIDENCE IN EFFECT).
One study68 of 20 participants found no significant difference in Elbow flexion force (N) between those participants who received upper limb functional training and those who received usual care at 3 months follow-up (LOW CONFIDENCE IN EFFECT).
One study68 of 20 participants found no significant difference in Elbow extension force (N) between those participants who received upper limb functional training and those who received usual care at 3 months follow-up (LOW CONFIDENCE IN EFFECT).
One study47 of 74 participants found no significant difference in walking speed (m/sec) between those participants who received lower limb functional training and those who received usual care at a follow-up of 3 months (MODERATE CONFIDENCE IN EFFECT).
One study47 of 74 participants found no significant difference in knee flexion peak torque between those participants who received lower limb functional training and those who received usual care at a follow-up of 3 months (LOW CONFIDENCE IN EFFECT).
One study47 of 74 participants found no significant difference in knee extension peak torque between those participants who received lower limb functional training and those who received usual care at a follow-up of 3 months (LOW CONFIDENCE IN EFFECT).
One study285 of 43 participants found that there was no significant difference in FIM – mobility score between the participants who received resistance training and those who received usual care after treatment (LOW CONFIDENCE IN EFFECT).
One study285 of 43 participants found that usual care was associated with statistically significant improvement in FIM – mobility score compared to resistance training at a follow-up of 9 months, although this difference was not of clinical significance (LOW CONFIDENCE IN EFFECT).
One study285 of 43 participants found that there was no significant difference in FIM – self-care score between the participants who received resistance training and those who received usual care after treatment (LOW CONFIDENCE IN EFFECT).
One study285 of 43 participants found that usual care was associated with statistically significant improvement in FIM – self-care score compared to resistance training at 9 months follow-up, although this difference was not of clinical significance (LOW CONFIDENCE IN EFFECT).
One study285 of 43 participants found that there was no significant difference in Fugl-Meyer – ROM score between the participants who received resistance training and those who received usual care after treatment (LOW CONFIDENCE IN EFFECT).
One study285 of 64 participants found that usual care was associated with statistically significant improvement in Fugl-Meyer – range of motion score compared to resistance training at a follow-up of 9 months (LOW CONFIDENCE IN EFFECT).
One study285 of 43 participants found that there was no significant difference in Fugl-Meyer – pain score between the participants who received resistance training and those who received usual care after treatment and at a follow-up of 9 months (LOW CONFIDENCE IN EFFECT).
One study285 of 64 participants found no significant difference in Fugl-Meyer – sensory score between those participants who received resistance training and those who received usual care after treatment and at a follow-up of 9 months (LOW CONFIDENCE IN EFFECT).
One study285 of 43 participants found that resistance training was associated with statistically significant improvement in FIM – motor function score compared to usual care after treatment, although this difference was not of clinical significance (LOW CONFIDENCE IN EFFECT).
One study285 of 64 participants found no significant difference in Fugl-Meyer – motor function score between those participants who received resistance training and those who received usual care at a follow-up of 9 months (LOW CONFIDENCE IN EFFECT).
One study84 of 24 participants found no significant difference in gait performance assessed by timed up and go test (sec) between those participants who received resistance training and those who received usual care at a follow-up of 5 months (VERY LOW CONFIDENCE IN EFFECT).
One study84 of 24 participants found no significant difference in gait performance assessed by fast gait speed (10m/sec) between those participants who received resistance training and those who received usual care at a follow-up of 5 months (LOW CONFIDENCE IN EFFECT)
One study178 of 133 participants found no significant difference in 2 minute walk test between those participants who received resistance training and those who received usual care at a follow-up of 6 months (MODERATE CONFIDENCE IN EFFECT).
One study195 of 42 participants found no significant difference in gait performance assessed by 6 minute walk test between those participants who received resistance training and those who received usual care at a follow-up of 3 months (MODERATE CONFIDENCE IN EFFECT).
One study84, of 24 participants found no significant difference in gait performance assessed by 6 minute walk test between those participants who received resistance training and those who received usual care at a follow-up of 5 months (VERY LOW CONFIDENCE IN EFFECT).
Two studies136,195 of 62 participants found no significant difference in self-selected/habitual gait speed between those participants who received resistance training and those who received usual care (LOW CONFIDENCE IN EFFECT)
Two studies136,195 of 62 participants found no significant difference in maximal gait speed between those participants who received resistance training and those who received usual care (LOW CONFIDENCE IN EFFECT)
Family mediated exercise (FAME) intervention compared to usual care (physiotherapy)
One study 88 of 40 participants found a significant improvement in Lower Limb Fugl-Meyer – motor function associated with the FAME intervention compared to usual care at the end of the 8 week intervention (LOW CONFIDENCE IN EFFECT). This improvement was not maintained at the end of the 3 months follow-up period (MODERATE CONFIDENCE IN EFFECT).
One study 88 of 40 participants found a significant improvement in everyday motor function (as assessed by the Motor Assessment Scale) associated with the FAME intervention compared to usual care at the end of the 8 week intervention (LOW CONFIDENCE IN EFFECT). This improvement was not maintained at the end of the 3 months follow-up period (LOW CONFIDENCE IN EFFECT).
One study 88 of 40 participants found a significant improvement in person’s static and dynamic balance abilities (as assessed by the Berg Balance Scale) associated with the FAME intervention compared to usual care at the end of the 8 week intervention (LOW CONFIDENCE IN EFFECT). This improvement was not maintained at the end of the 3 months follow-up period (LOW CONFIDENCE IN EFFECT).
One study 88 of 40 participants found a significant improvement in functional exercise capacity (as assessed by the 6 minute walk test) associated with the FAME intervention compared to usual care at the end of the 8 week intervention (MODERATE CONFIDENCE IN EFFECT). This improvement was still significant at the end of the 3 months follow-up period but the effect was not as large as post intervention (LOW CONFIDENCE IN EFFECT).
One study 88 of 40 participants found a significant improvement in the performance in activities of daily living (as assessed by the Barthel Index) associated with the FAME intervention compared to usual care at the end of the 8 week intervention (MODERATE CONFIDENCE IN EFFECT). This improvement was still significant at the end of the 3 months follow-up period but the effect was not as large as post intervention (LOW CONFIDENCE IN EFFECT).
Economic evidence statements
No cost effectiveness evidence was identified.
13.1.2. Recommendations and link to evidence
| |
|---|---|
| Relative values of different outcomes | The range of outcomes reflected impairment (force), activity (walking speed and distance, Action Research Arm test), and dependence (Barthel Index and Functional Independence Measure). Improvements in strength would be postulated to lead to improvements of function and thus measures of mobility, activity, and dependence are of potentially more interest. However, in small studies measures of impairment may be responsive to the intervention. Adverse events were also regarded as an important outcome, particularly the development of increased tone. The GDG noted that some health professionals have expressed a concern that strength training may be associated with an increase in tone that in time, may lead to deterioration in function. In this context, the GDG considered it important to recognise the incidence of disabling spasticity in stroke which has been reported as 4% by Lumstrom et al. 161 |
| Trade-off between clinical benefits and harms | One study 84 stated there were no injuries associated with the resistance training exercise machine used. None of the other studies reported any adverse events from the strength training interventions. The GDG agreed that that there would not normally be any detrimental effect from these types of interventions. Weakness of the face, upper limb, trunk and lower limb are common deficits after stroke, As well as strength, sensory disturbance and balance difficulties impact on movement. It was felt that trained physiotherapists with the relevant skills and training in the diagnosis, assessment and management of movement in people with stroke should regularly monitor and treat people with movement difficulties until they are able to maintain or progress function either independently or with assistance from others (rehabilitation assistants, carers, fitness instructors etc.). One study reported significant improvements in motor and balance function associated with strength training using family members as co-trainers. The evidence for outcomes from this study were of low to moderate quality. However, improvements were not maintained over a three month follow-up period. |
| Economic considerations | No cost effectiveness studies were identified for this question. The main difference in costs between the providing muscle power training and usual care was due to the amount of additional personnel time required. In addition, there may also be some device costs, for example an exercise machine was used in one of the studies included in the clinical review. However, when the cost of the machine is spread over the lifetime of the equipment and the amount of usage, the cost per patient per session is expected to be low. Based on resource use from Cooke (2010 – lower limb strength training intervention)47 the additional cost of strength training over usual care was estimated to be £1080 and based on Flansbjer (2008 – resistance training intervention)84 it was estimated to be £1350 (personnel costs only). The GDG considered it likely that strength training would be cost effective as the potential improvement for patients in terms of quality of life from improved function would justify any additional costs of the intervention. |
| Quality of evidence | Many of the studies were limited by small numbers (maximum sample size= 133), some were feasibility studies, inadequately powered and duration of follow-up and time since onset of stroke varied between studies. Because of the wide range of different types of strength training and outcome measures included within the studies it was not possible to carry out any meta-analysis and therefore interpretation of the results was limited. Confidence in the results shown for the majority of the outcomes was low to very low because of study limitations (unclear blinding, unclear randomisation and lack of allocation concealment) and imprecision around the effect estimate. The group agreed it was not clear whether there would be a persistent difference between the groups at 6 months or 1 year. The GDG agreed that it was difficult to determine the treatment effect from the small study sizes presented. The group agreed that there was no clear evidence to show that strength training is better than the control interventions (usual practice) but both strength training and usual practice led to improvements so the consensus of the group was that this strength training is useful for those with weakness in upper or lower limbs, and therefore could be considered as part of a person’s rehabilitation. |
| Other considerations | Definitions of strength training vary from traditional resistance training to functional strength training. Conventional resistance training would include exercises such as lifting weights in a gym, whereas functional strength training focuses on building stamina through a range of tasks such as walking and graded activities delivered by a rehabilitation professional. The nature of strength training varied according to whether it was upper or lower limb and time since onset of the stroke. There was no indication from the studies presented of what dose of strength training is appropriate. It was also highlighted that evidence for strength training which involved a family member showed short term improvements. Yet these were short lived and therefore seem not to make a contribution to long term functional gains. |
13.2. Fitness Training
13.2.1. In people after stroke, does cardiorespiratory or resistance fitness training improve outcome (fitness, function, quality of life, mood) and reduce disability?
| Clinical Methodological Introduction | |
|---|---|
| Population | Adults and young people 16 or older who have had a stroke. |
| Intervention | Any cardiorespiratory or resistance fitness training such as: Aquatic physical exercise Cycle, rowing or treadmill ergometry Weight bearing resistance training Dynamic and isokinetic muscle strength training |
| Comparison | Usual care (other physiotherapy) |
| Outcomes |
|
13.2.1.1. Clinical Evidence Review
Searches were conducted for systematic reviews comparing the clinical effectiveness of fitness training (cardiorespiratory or resistance) with usual care to improve function and reduce disability for adults and young people 16 or older who have had a stroke.
One Cochrane systematic review (Brazzelli 2011 31) was identified. This Cochrane review was adapted to address the current protocol (the comparison of mixed cardiorespiratory vs. usual care was removed and outcomes that had already been included in the review in 12.1 were removed from the resistance vs. usual care comparison). The Cochrane review included 32 trials. From these trials (32), 21 trials matching our protocol were included for this review.
A further systematic search was conducted for any trial published since the Cochrane search cut-off (March 2010) and four trials (Globas 201294, Holmgren 2010 113, Jin 2012 125 and Van De Port 2012267) was identified.
In the systematic review the following strategy of analysis was adopted:
- The effects of the interventions were separately analysed at the ‘end of the intervention’ and at the ‘end of follow-up’. ‘End of intervention’ refers to the time-point when a training programme finishes (ranged from 2 – 14 weeks) and ‘end of follow-up’ refers to any time-point occurring after the end of intervention (ranged from 12 – 36 weeks). (See individual GRADE Table 92/ Table 93 for cardiorespiratory and Table 94/Table 95 for resistance training). Retained training effects were measured at the end of follow-up.
- Studies were included in which controls were exposed to either physical activity occurring during usual care or ‘no training’ after usual care. ‘No training’ refers to no intervention or a non-exercise intervention. These were sub group analyses within each GRADE table
- Cardiorespiratory training was also compared with resistance training using one mobility outcome (see GRADE Table 96)
- When there is an outcome with sub group, overall effects as well as sub-group analyses (in italics) are presented (see GRADE tables )
- The evidence statements also reflect the total effects as well as the sub-group analysis.
Table 92
Cardiorespiratory training – end of intervention versus usual care - Clinical study characteristics and clinical summary of findings. Sub-groups are in italics.
Table 93
Cardiorespiratory training – end of retention follow-up versus usual care - Clinical study characteristics and clinical summary of findings.
Table 94
Resistance training - end of intervention versus usual care- Clinical study characteristics and clinical summary of findings.
Table 95
Resistance training - end of retention follow-up versus usual care- Clinical study characteristics and clinical summary of findings.
Table 96
Cardiorespiratory versus resistance training- Clinical study characteristics and clinical summary of findings.
Please see Appendix M for excluded trials from the Cochrane review.
Table 90 summarises the population, intervention, comparison and outcomes for each of the studies.
Table 90
Overview of studies included in the Cochrane review.
Table 91
Details of four additional RCTs that were completed since the Cochrane review and were added to the current review. See Appendix H for extraction
Comparison: Cardiorespiratory training versus usual care
Comparison: Cardiorespiratory training versus usual care
Comparison: Resistance training versus usual care
Comparison: Resistance training versus usual care
Comparison: Cardiorespiratory versus resistance training
13.2.1.2. Economic evidence
Literature review
No relevant economic evaluations were identified on cardiorespiratory or resistance fitness training.
Intervention costs
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
Cardiorespiratory training is delivered as part of usual rehabilitation programmes by physiotherapists. The cost per hour of a community based physiotherapist is £30.51 The GDG acknowledged that additional costs would be incurred if people are referred for training programmes post-rehabilitation.
13.2.1.3. Evidence statements
Clinical evidence statements
End of intervention
Functional independence measure
Three studies19 52 134 of 162 participants found no significant difference in FIM – Disability between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
- One study19 of 52 participants found no significant difference in FIM –Disability between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT)
Rivermead Mobility Index
Four studies19,125,267 94 of 488 participants found that cardiorespiratory training was associated with a significant improvement in the level of disability as measured by Rivermead Mobility Index, compared to usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT). Rivermead Mobility Index was then subdivided into groups of studies where participants in the control group still received usual care rehabilitation (during usual care) and those where participants were recruited who may not currently receive usual care rehabilitation (after usual care).
- During usual care: Three studies19,125,267 94 comprising 452 participants found that cardiorespiratory training was associated with a significant improvement in the level of disability, as measured by the Rivermead Mobility Index, compared to usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT).
Physical Activity and Disability scale
One study180 of 58 participants found no significant difference in the Physical Activity and Disability scale between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Systolic blood pressure
Four studies53 134 152 211 of 190 participants found no significant difference in systolic blood pressure –Risk factors between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
- One study53 of 12 participants found that usual care was associated with statistically significant improvement in systolic blood pressure –Risk factors compared to the cardiorespiratory training at the end of intervention (LOW CONFIDENCE IN EFFECT)
Diastolic blood pressure
Four studies53 134 152 211 of 190 participants found no significant difference in diastolic blood pressure –Risk factors between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT)
- One study53 of 12 participants found no significant difference in diastolic blood pressure –Risk factors between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
Peak VO2
Six studies53 152 177 94,125,211 comprising 289 participants found a significant improvement in peak oxygen uptake (VO2) – Physical fitness in favour of the participants that received cardio-respiratory training compared to the participants that received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
- Two studies 53,125 of 145 participants found a significant difference in peak oxygen uptake (VO2) – Physical fitness in favour of the participants that received cardio-respiratory training compared to the participants that received usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT)
- Four studies152 177 94,211 of 144 participants found a significant improvement in peak oxygen uptake (VO2) – Physical fitness in favour of the participants that received cardio-respiratory training compared to the participants that received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Gait economy, VO2
One study177 of 20 participants found no significant difference in Gait economy, VO2-Physical fitness between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
Maximum cycling work rate
Four studies19 53 134 211 of 221 participants found that cardiorespiratory training was associated with a statistically significant difference in maximum cycling work rate-Physical fitness compared to usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Body mass (KG)
One study19 of 72 participants found no significant difference in Body mass (KG) – Physical fitness between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT)
Functional Ambulation Categories
Two studies53 208 of 73 participants found that cardiorespiratory training was associated with statistically significant improvement in Functional Ambulation Categories – Mobility compared to the usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Maximal gait speed
Seven studies53 208 19,74 229 177 180 of 365 participants found that cardiorespiratory training was associated with statistically significant improvement in maximal gait speed - Mobility compared to the usual care at the end of intervention, although this difference was not of clinical significance (MODERATE CONFIDENCE IN EFFECT)
- Three studies229 177 180 of 169 participants found that cardiorespiratory training was associated with statistically significant improvement in maximal gait speed - Mobility compared to the usual care at the end of intervention. This difference was not clinically significant (LOW CONFIDENCE IN EFFECT)
Preferred gait speed
Four studies52 134 177 229 of 221 participants found that cardiorespiratory training was associated with statistically significant improvement in preferred gait speed - Mobility compared to the usual care at the end of intervention. This difference was of clinical significance (MODERATE CONFIDENCE IN EFFECT)
- One study52 of 20 participants found no significant difference in preferred gait speed - Mobility between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
- Three studies134 177 229 of 201 participants found that cardiorespiratory training was associated with statistically significant improvement in preferred gait speed - Mobility compared to the usual care at the end of intervention. This difference was of clinical significance (MODERATE CONFIDENCE IN EFFECT)
Gait endurance (6-MWT metres)
Seven studies74 177 180 94,125,229,267 of 630 participants found that cardiorespiratory training was associated with statistically significant improvement in gait endurance (6-MWT metres) - Mobility compared to the usual care at the end of intervention. (VERY LOW CONFIDENCE IN EFFECT)
- Four studies177 180 229 94 of 205 participants found that cardiorespiratory training was associated with statistically significant improvement in gait endurance (6-MWT metres) - Mobility compared to the usual care at the end of intervention. This difference was not clinically significant (LOW CONFIDENCE IN EFFECT)
Maximal gait speed (m/sec over 10 meters)
One study 94 of 36 participants found that cardiorespiratory training was associated with statistically significant improvement in maximal gait speed – Mobility (m/sec over 10 meters) compared to the usual care at the end of intervention, although this difference was not of clinical significance (Low CONFIDENCE IN EFFECT)
Comfortable gait speed (m/sec over 5 to 10 meters)
Two studies94,267 of 278 participants found that cardiorespiratory training was associated with statistically significant improvement in comfortable gait speed - Mobility compared to the usual care at the end of intervention. (LOW CONFIDENCE IN EFFECT)
- One study267 of 242 participants found that cardiorespiratory training was associated with statistically significant improvement in comfortable gait speed - Mobility compared to the usual care at the end of intervention. (LOW CONFIDENCE IN EFFECT)
- One study94 of 36 participants found cardiorespiratory training was not associated with statistically significant improvement in comfortable gait speed - Mobility compared to the usual care at the end of intervention. (LOW CONFIDENCE IN EFFECT)
Gait endurance (m/min)
Three studies53 74 229 of 154 participants found that cardiorespiratory training was associated with statistically significant improvement in gait endurance (m/min) - Mobility compared to the usual care at the end of intervention, although this difference was not of clinical significance(LOW CONFIDENCE IN EFFECT)
- One study229 of 91 participants found no significant difference in gait endurance (m/min) - Mobility between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
6 metre walking time (sec)
One study93 of 20 participants found no significant difference in 6 metre walking time (sec) - Mobility between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Stroke Impact Scale
Two studies244,267 of 262 participants found that cardiorespiratory training was associated with a statistically significant improvement in the impact of the stroke, as measured by the stroke impact scale – Mobility, compared to the usual care at the end of intervention. (MODERATE CONFIDENCE IN EFFECT)
- One study267 of 242 participants found that cardiorespiratory training was associated with statistically significant improvement in the impact of the stroke, as measured by the stroke impact scale – Mobility, compared to the usual care at the end of intervention. (MODERATE CONFIDENCE IN EFFECT)
- One study244 of 20 participants found no significant difference in Stroke Impact Scale (mobility domain) between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
Peak activity index (steps/min)
One study180 of 58 participants found that cardiorespiratory training was associated with statistically significant improvement in Peak activity index (steps/min) – mobility compared to the usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Maximum step rate
One study180 of 58 participants found that cardiorespiratory training was associated with statistically significant improvement in Maximum step rate – mobility compared to the usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Berg Balance scale
Five studies19 229 94,177 125 of 357 participants found no significant difference in Berg Balance scale – Physical function between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Time Up and Go measure
Three studies 229 177,267 of 353 participants found that cardiorespiratory training significantly improved Timed Up and Go response – Physical function compared to usual care at the end of intervention. This improvement was not large enough to indicate clear clinical benefit (HIGH CONFIDENCE IN EFFECT).
- During usual care: One study 267 of 142 participants that cardiorespiratory training significantly improved Timed Up and Go response – Physical function compared to usual care at the end of intervention. This improvement was not large enough to indicate clear clinical benefit (HIGH CONFIDENCE IN EFFECT)
Health related QoL
One study3 of 28 participants found that cardiorespiratory training was associated with statistically significant improvement in Health related QoL (SF-36 - Emotional role functioning domain) compared to the usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Three studies 3,94,113 of 97 participants found no significant difference in Health related QoL (SF-36 or SF-12 - Physical functioning domain) between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
One study113 of 33 participants found no significant difference in Health related QoL (SF-36 - Emotional role functioning domain) between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
One study113 of 33 participants found no significant difference in Health related QoL (SF-36 - Mental health domain) between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
One study113 of 33 participants found no significant difference in Health related QoL (SF-36 - Physical Component scale) between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
One study113 of 33 participants found no significant difference in Health related QoL (SF-36 - Mental Component scale) between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
Mood
One study244 of 20 participants found no significant difference in Mood (Beck Depression Index) between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
Two studies 19,267 of 302 participants found that cardiorespiratory training was not associated with statistically significant improvement in anxiety (HADS – anxiety score) compared to the usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT)
Three studies19,113,267 of 60 participants found no significant difference in depression (measured by HADS – depression score or the Geriatric Depression Scale) between the participants who received cardiorespiratory training and those who received usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT)
End of retention follow-up
Case fatality
One study134 of 81 participants found no significant difference in case fatality between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (VERY LOW CONFIDENCE IN EFFECT)
Rivermead Mobility Index
One study19 of 66 participants found no significant difference in the Rivermead Mobility Index between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (MODERATE CONFIDENCE IN EFFECT)
Nottingham Extended ADL
One study19 of 64 participants found no significant difference in the Nottingham Extended ADL between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (MODERATE CONFIDENCE IN EFFECT)
Physical Activity and Disability Scale
One study180 of 58 participants found no significant difference in the Physical Activity and Disability Scale between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (LOW CONFIDENCE IN EFFECT)
Frenchay Activities Index
One study134 of 79 participants found no significant difference in Frenchay Activities Index between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (LOW CONFIDENCE IN EFFECT)
Maximum cycling work rate
One study19 of 66 participants found no significant difference in maximum cycling work rate between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (MODERATE CONFIDENCE IN EFFECT)
Body mass (Kg)
One study19 of 64 participants found no significant difference in Body mass (Kg) between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (MODERATE CONFIDENCE IN EFFECT)
Maximal gait speed
Three studies19,74 180 of 186 participants found that cardiorespiratory training was associated with statistically significant improvement in maximal gait speed - Mobility compared to the usual care at the end of retention follow-up, although this difference was not of clinical significance (MODERATE CONFIDENCE IN EFFECT)
- Two studies19,74 of 128 participants found that cardiorespiratory training was associated with statistically significant improvement in maximal gait speed - Mobility compared to the usual care at the end of retention follow-up, although this difference was not of clinical significance (MODERATE CONFIDENCE IN EFFECT)
- One study180 of 58 participants found that cardiorespiratory training was associated with statistically significant improvement in maximal gait speed - Mobility compared to the usual care at the end of retention follow-up, although this difference was not of clinical significance (LOW CONFIDENCE IN EFFECT)
6 Minute Walk Test
Two studies74 180 of 107 participants found that cardiorespiratory training was associated with statistically significant improvement in 6 Minute Walk Test - Mobility compared to the usual care at the end of retention follow-up. This difference was of clinical significance (HIGH CONFIDENCE IN EFFECT)
- One study74 of 49 participants found that cardiorespiratory training was associated with statistically significant improvement in 6 Minute Walk Test - Mobility compared to the usual care at the end of retention follow-up. This difference was not clinically significant (MODERATE CONFIDENCE IN EFFECT)
- One study180 of 58 participants found that cardiorespiratory training was associated with statistically significant improvement in 6 Minute Walk Test - Mobility compared to the usual care at the end of retention follow-up. This difference was not clinically significant (LOW CONFIDENCE IN EFFECT)
Peak activity index (steps/min)
One study180 of 58 participants found that cardiorespiratory training was associated with statistically significant improvement in peak activity index (steps/min) - Mobility compared to the usual care at the end of retention follow-up (LOW CONFIDENCE IN EFFECT)
Maximum step rate
One study180 of 58 participants found that cardiorespiratory training was associated with statistically significant improvement in maximum step rate - Mobility compared to the usual care at the end of retention follow-up (LOW CONFIDENCE IN EFFECT)
Stroke Impact Scale
One study244 of 20 participants found no significant difference in Stroke Impact Scale (mobility domain) between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (VERY LOW CONFIDENCE IN EFFECT)
Berg Balance scale
One study19 of 66 participants found no significant difference in Berg Balance scale – Physical function between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (MODERATE CONFIDENCE IN EFFECT)
Mood
One study244 of 20 participants found no significant difference in Mood (Beck Depression Index) between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (VERY LOW CONFIDENCE IN EFFECT)
One study19 of 53 participants found no significant difference in Mood (HADS – anxiety score) between the participants who received cardiorespiratory training and those who received usual care at the end of retention follow-up (MODERATE CONFIDENCE IN EFFECT)
One study19 of 53 participants found that cardiorespiratory training was associated with statistically significant improvement in Mood (HADS – depression score) compared to the usual care at the end of retention follow-up (MODERATE CONFIDENCE IN EFFECT)
One study113 of 31 participants found no significant difference in Mood (Geriatric Depression Scale) between the participants who received cardiorespiratory training and those who received usual care at 6 months post-intervention (LOW CONFIDENCE IN EFFECT)
Health related QoL
One study113 of 31 participants found no significant difference in Health related QoL (SF-36 - Physical Component scale) between the participants who received cardiorespiratory training and those who received usual care at 6 months post-intervention (VERY LOW CONFIDENCE IN EFFECT)
One study113 of 31 participants found no significant difference in Health related QoL (SF-36 - Mental Component scale) between the participants who received cardiorespiratory training and those who received usual care at 6 months post-intervention (LOW CONFIDENCE IN EFFECT)
One study113 of 31 participants found no significant difference in Health related QoL (SF-36 - Physical functioning domain) between the participants who received cardiorespiratory training and those who received usual care at 6 months post-intervention (VERY LOW CONFIDENCE IN EFFECT)
One study113 of 31 participants found no significant difference in Health related QoL (SF-36 - Emotional role functioning domain) between the participants who received cardiorespiratory training and those who received usual care at 6 months post-intervention (LOW CONFIDENCE IN EFFECT)
One study113 of 31 participants found no significant difference in Health related QoL (SF-36 - Mental health domain) between the participants who received cardiorespiratory training and those who received usual care at 6 months post-intervention (VERY LOW CONFIDENCE IN EFFECT)
Resistance training: End of intervention
Muscle strength
Two studies285 136 of 60 participants found that resistance training was associated with statistically significant improvement in composite measure of muscle strength compared to usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
- One study285 of 40 participants found no significant difference in composite measure of muscle strength between the participants who received resistance training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
- One study136 of 20 participants found no significant difference in composite measure of muscle strength between the participants who received resistance training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Knee extension (Nm)
Two studies 14 84 of 42 participants found no significant difference in knee extension (Nm) between the participants who received resistance training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
- One study 14 of 18 participants found no significant difference in knee extension (Nm) between the participants who received resistance training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
- One study 84 of 24 participants found that resistance training was associated with statistically significant improvement in knee extension (Nm) compared to usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Knee flexion (Nm)
Two studies 14 84 of 42 participants found no significant difference in knee flexion (Nm) between the participants who received resistance training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
- One study 14 of 18 participants found no significant difference in knee flexion (Nm) between the participants who received resistance training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
- One study 84 of 24 participants found that resistance training was associated with statistically significant improvement in knee flexion (Nm) compared to usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Maximal gait speed
Two studies 14 84 of 42 participants found no significant difference in maximal gait speed between the participants who received resistance training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
- One study 14 of 18 participants found that resistance training was associated with statistically significant improvement in maximal gait speed compared to usual care at the end of intervention, although this difference was not of clinical significance (VERY LOW CONFIDENCE IN EFFECT)
- One study 84 of 24 participants found no significant difference in maximal gait speed between the participants who received resistance training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Preferred gait speed
One study 14 of 18 participants found that resistance training was associated with statistically significant improvement in preferred gait speed compared to usual care at the end of intervention, although this difference was not of clinical significance (VERY LOW CONFIDENCE IN EFFECT)
Rivermead Mobility Index
One study 47 of 68 participants found no significant difference in Rivermead Mobility Index between the participants who received resistance training and those who received usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT)
Weight bearing (affected side)
One study 14 of 18 participants found that resistance training was associated with statistically significant improvement in weight bearing (affected side) compared to usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
Stair climbing
Two studies 136 195 of 61 participants found no significant difference in stair climbing between the participants who received resistance training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
Timed Up and Go (sec)
One study 84 of 24 participants found no significant difference in Timed Up and Go (sec) between the participants who received resistance training and those who received usual care at the end of intervention (LOW CONFIDENCE IN EFFECT)
Health related QoL
One study 136 of 20 participants found no significant difference in Health related QoL (SF-36 - Physical functioning domain) between the participants who received resistance training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
One study 136 of 20 participants found no significant difference in Health related QoL (SF-36 – Mental health domain) between the participants who received resistance training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
EuroQoL
One study 47 of 67 participants found no significant difference in EuroQoL (Self-perceived health) between the participants who received resistance training and those who received usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT)
Mood
One study 238 of 88 participants found that resistance training was associated with statistically significant improvement in Mood (Centre for Epidemiology Studies for Depression scale) compared to usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
End of retention follow-up
Knee extension (Nm)
One study 84 of 24 participants found no significant difference in knee extension (Nm) between the participants who received resistance training and those who received usual care at the end of retention follow-up (LOW CONFIDENCE IN EFFECT)
Knee flexion (Newton metre)
One study 84 of 24 participants found no significant difference in knee flexion (Nm) between the participants who received resistance training and those who received usual care at the end of retention follow-up (LOW CONFIDENCE IN EFFECT)
Maximal gait speed
One study 84 of 24 participants found no significant difference in maximal gait speed between the participants who received resistance training and those who received usual care at the end of retention follow-up (MODERATE CONFIDENCE IN EFFECT)
Rivermead Mobility Index
One study 47 of 51 participants found no significant difference in Rivermead Mobility Index between the participants who received resistance training and those who received usual care at the end of retention follow-up (LOW CONFIDENCE IN EFFECT)
Timed Up and Go (sec)
One study 84 of 24 participants found no significant difference in Timed Up and Go (sec) between the participants who received resistance training and those who received usual care at the end of retention follow-up (LOW CONFIDENCE IN EFFECT)
Mood
One study 238 of 86 participants found that resistance training was associated with statistically significant improvement in Mood (Centre for Epidemiology Studies for Depression scale) compared to usual care at the end of retention follow-up (VERY LOW CONFIDENCE IN EFFECT)
EuroQoL
One study 47 of 49 participants found no significant difference in EuroQoL (Self-perceived health) between the participants who received resistance training and those who received usual care at the end of retention follow-up (MODERATE CONFIDENCE IN EFFECT)
Cardiorespiratory versus Resistance training
Preferred gait speed
Four studies52 134 177 229 of 221 participants found that cardiorespiratory training was associated with statistically significant improvement in preferred gait speed - Mobility compared to the usual care, although this difference was not of clinical significance (LOW CONFIDENCE IN EFFECT)
Three studies 14 136 195 of 80 participants found no significant difference in preferred gait speed - Mobility between the participants who received resistance training and those who received usual care at the end of intervention (VERY LOW CONFIDENCE IN EFFECT)
Economic evidence statement
No cost-effectiveness evidence was identified.
13.2.2. Recommendations and links to evidence
| |
|---|---|
| Relative values of different outcomes | The GDG agreed that being fit has an impact on: cardiovascular mortality, obesity, speed, endurance and mood. The GDG considered those outcomes measuring fitness, mobility and mood to be important. |
| Trade-off between clinical benefits and harms | There is a general agreement that physical activity is beneficial. The Cochrane review demonstrated improvements in physical fitness, mobility and mood and that respiratory training improved speed, tolerance and independence in walking. The GDG noted that all people included within the studies had some walking capacity at baseline. The studies did not comment on harm or potential side-effects. Adverse events were not consistently reported within these studies but require serious consideration. The GDG agreed that people need to be cardiovascularly stable (their treatment is not changing and their symptoms are not getting worse), but having symptoms does not mean that they cannot exercise. The GDG agreed that cardiovascular exercise was safe under supervision for certain people. It was agreed that an assessment should be undertaken by a health professional to establish suitability for this type of intervention but that the benefits of exercise in preventing further deterioration were established. The group agreed that most fitness training is done in the community and as out-patients, and there are now programmes available of adapted fitness programmes suitable for a stroke population that would be safe. Ideally people would start their exercise programme under supervision of a community physiotherapist and then a personal trainer who had knowledge and experience of working with people with disabilities who would continue the programme. Shoulder pain is the most likely harm people experience and therefore the GDG agreed that a recommendation to direct people to seek medical advice should be made. |
| Economic considerations | Cardiorespiratory training is delivered as part of usual rehabilitation programmes by physiotherapists. Fitness training is done in the community and the cost per hour of a community based physiotherapist is £30. The GDG acknowledged that additional costs would be incurred if people are referred for training programmes post- rehabilitation; the GDG felt that the potential costs of cardiorespiratory and fitness training are likely to be outweighed by the benefits. |
| Quality of evidence | The confidence in the effect of specified outcomes range from high to very low. Significant effects were found in the domains where such changes might be anticipated with cardiorespiratory and resistance interventions (i.e. physical fitness and mobility outcomes). These findings are consistent with results in other patient groups for similar fitness intervention studies. In the groups who received cardiorespiratory training significant improvements were found for gait speed, gait endurance and measures of physical fitness at the ‘end of intervention’ (time-point when a training programme finishes) and were retained at the ‘end of follow-up’ (any time-point occurring after the end of the intervention). Two recent large scale studies125,267 contributed to many mobility outcomes and resulted in larger improvements of high to low quality for these outcomes. This also includes measures of stroke impact the evidence of which was rated as moderate quality. |
| Other considerations | The group felt that participating in exercise should generally be encouraged. The GDG also noted that the findings of the review were uncontroversial in that they highlight mobility and fitness as the main health gains. There was a discussion about medical suitability and the role of medical advice with regards to cardiorespiratory/resistance training. It was felt that there could potentially be serious medical risks associated with fitness training since many people who have had a stroke also have cardiac conditions. Since there would be a trade-off between benefits and potential harms, clinicians should assess and discuss these with people who have had a stroke who are considering taking part in such activities. The GDG also debated the issue of individual preference and personal history. Whether a person wants to take part in exercise training could depend on previous activity levels and work / life commitments. The group acknowledged a distinction between the goals of those wanting to regain functional ability and those who want to commit to progressive cardio-respiratory exercise requiring significant time and effort. Whilst fitness training may not be suitable or wanted by everyone, it was agreed physical activity at whatever level should be offered and promoted. The GDG highlighted the ‘Start active stay active’ report promoting regular physical activity throughout a person’s life 62. Although fitness training tends to be done more commonly in the community setting rather than in the acute setting, studies have been done safely in the acute setting. |
13.3. Hand and arm therapies: orthoses for the upper limb
Hand orthoses, or splints, are usually light-weight, formed supports for providing protection, rest, or alignment for the fingers, hand and wrist. After stroke, if hand function does not return, soft tissue tightness and contractures often occur leading to secondary problems of further limited function, pain, oedema and possibly, worsening spasticity. Hand splints are sometimes provided to aid in maintaining the length of soft tissues and thus the range of motion of the joints. They are also thought to reduce the effects of spasticity. However, there is differing opinion with regards to the design, schedules and clinical aims for upper limb splinting, as well as both biomechanical and neurophysiological clinical rationales. Additionally, there are respected members of the therapy professions who both support and contest the use of this clinical tool (Lannin NA, 2003 145).
13.3.1. Evidence review: In people after stroke what is the clinical and cost-effectiveness of orthoses for prevention of loss of range of movement in the upper limb versus usual care?
| Clinical Methodological Introduction | |
|---|---|
| Population: | Adults and young people 16 or older who have had a stroke. |
| Intervention: | Orthoses for the upper limb including:
|
| Comparison: | Usual Care |
| Outcomes: | Range of movement assessed by goniometry |
13.3.1.1. Clinical evidence
Searches were conducted for systematic reviews and RCTs comparing the effectiveness of different types of orthoses as interventions for prevention of loss of range of movement in the upper limb for adults and young people over 16 years who had a previous stroke. Only studies with a minimum sample size of 20 participants (10 in each arm) were selected. Two RCTs18,144 were identified. Table 97 summarises the population, intervention, comparison and outcomes of the study.
Table 97
Summary of studies included in the clinical evidence review. For full details of the extraction please see Appendix H.
Comparison: Neutral splint versus usual care
Table 98
Neutral splint versus usual care - Clinical study characteristics and clinical summary of findings.
Comparison: Extension splint versus usual care
Table 99
Extension splint versus usual care - Clinical study characteristics and clinical summary of findings.
Comparison: Dorsal / Volar splint versus usual care
Table 100
Dorsal / Volar splint versus usual care - Clinical study characteristics and clinical summary of findings.
13.3.1.2. Economic evidence
Literature review
No relevant economic evaluations comparing orthoses for prevention of loss of range of the upper limb with usual care were identified.
Intervention costs
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
The cost of providing wrist/hand orthoses was based on the RCT included in clinical review. In Lannin et al (2007)144, they used custom-made static, palmar mitt splints. An expert advisor to the GDG provided the cost for a pre-fabricated splint: Resting pan position splint, £33.93 excluding VAT, though costs will vary according to type and design of prefabricated splint.
Custom-made orthoses would be made by a member of specialist multidisciplinary orthotics team and would incur extra costs. In addition, there would be personnel costs related to the time required to make and adjust the ULO to take into account the specific patient’s needs. Adjustments may be made by either orthotists and experienced physiotherapists or occupational therapists (band 6 or 7), depending on the requirements (for example orthotists tend to make permanent and more complex adjustments). The estimated costs range from £45 to £59 per hour of client contactr.
13.3.1.3. Evidence statements
Clinical evidence statements
Neutral splint
One study144 comprising 42 participants found no significant difference on the wrist extensibility at 4 and 6 weeks follow-up for participants wearing neutral splint for 4 weeks compared to participants who received usual care. (MODERATE CONFIDENCE IN EFFECT)
Extension splint
One study144 comprising 42 participants found no significant difference on the wrist extensibility at 4 and 6 weeks follow-up for participants wearing extension splint for 4 weeks compared to participants who received usual care. (MODERATE CONFIDENCE IN EFFECT)
Dorsal splint
One study 18 comprising 26 participants found no significant difference on the passive range of motion (PROM) of wrist extension after 5 weeks of intervention for participants wearing a static dorsal splint compared to participants who received usual care. (LOW CONFIDENCE IN EFFECT)
Volar splint
One study18 comprising 26 participants found no significant difference on the passive range of motion (PROM) of wrist extension after 5 weeks of intervention for participants wearing a static volar splint compared to participants who received usual care. (MODERATE CONFIDENCE IN EFFECT)
Economic evidence statements
No cost effectiveness evidence was identified.
13.3.2. Recommendations and link to evidence
| Recommendations: |
|
|---|---|
| Relative values of different outcomes | Wrist splints are used to ensure that range of movement is not lost following stroke. Should loss of range of movement occur this would have an impact on upper limb function should movement at the hand and wrist recover. For this reason the outcome of interest included in the review was range of movement. The GDG noted that range of movement is one of a number of potential outcomes which include function and amount of muscle tone |
| Trade-off between clinical benefits and harms | An assessment of the use of splints includes checking if it fits and is worn properly, and a review plan established. The GDG agreed that information and training for the patient and carers was important for them to ensure the splint was used correctly and to recognise any adverse effects that would need professional care and advice. Potential contraindications may include sensory impairment, spasticity, poor skin condition including inflammation, oedema, and poor vascular supply, each of which may contribute to skin break down after stroke. The GDG agreed it was essential that the splint is assessed, fitted and monitored by staff trained in this area. |
| Economic considerations | No cost effectiveness studies were identified for this question. The cost of a pre-fabricated splint was estimated at around £34 excluding VAT though costs vary considerably. In addition, there is some personnel time required to assess and make adjustments for the patient as well as to ensure its correct use. Custom-made orthoses would be made by a member of specialist multidisciplinary orthotics team and would incur extra costs. In addition, there would be personnel costs related to the time required to make and adjust the ULO to take into account the specific patient’s needs. Based on the results of the clinical review, the GDG did not consider wrist and hand splinting to be cost-effective as a routine treatment in the majority of patients. |
| Quality of evidence | Only two small studies, one in early post-acute stroke and one in later stroke rehabilitation were identified 18,144. Confidence in the results seen in the wrist extensibility outcome was moderate to low due to not reaching the minimal important difference of 5 degrees as previously agreed with the GDG (see the method chapter) or the default MID. However the GDG considered both of these studies to be a robust rehabilitation studies and acknowledged the difficulties of double blinding in this type of intervention. |
| Other considerations | The GDG consensus was that routine splinting early after stroke would probably not be of benefit, except in selected patients where splinting may be used to help manage tone, reduce pain and improve function. Whether or not to use splints later on in the rehabilitation pathways was seen as unclear since the results can be interpreted as being inconclusive. Further research is needed to assess whether upper limb splinting in conjunction with other modalities aids the management of spasticity. To date, the details are not known as to whether upper limb splinting is useful in reducing problems in the poorly functioning hand after stroke either as a single intervention or in combination with other interventions such as botulinum toxin injections or electrical stimulation. |
13.4. Electrical stimulation: upper limb
Functional electrical stimulation (FES) and neuromuscular electrical stimulation (NMES), used here to indicate a generic form of therapeutic electrical stimulation (ES) to muscles, are an adjunct to a comprehensive rehabilitation program to improve arm and hand function after stroke. It may be used for therapeutic purposes or for functional purposes. ES is seldom used in isolation, but most recently in tandem with or in addition to an active task oriented, exercise program. ES, applied usually via surface electrodes, but also occasionally through implanted electrodes, activates muscle contraction peripherally usually through stimulating nerves to muscles. With current technology, ES devices are small and easy to use and can be pre-programmed to prescribed cycles and duration, include multiple muscle groups, be passively or actively triggered and be used in some functional activities. Once set up by the appropriate health professional, the treatment can often be continued at home, enhancing the practice effect.
13.4.1. Evidence review: In people after stroke what is the clinical and cost-effectiveness of electrical stimulation (ES) for hand function versus usual care?
| Clinical Methodological Introduction | |
|---|---|
| Population | Adults and young people 16 or older who have had a stroke |
| Intervention | Functional Electrical Stimulation (FES) with or without robotics, ES with or without transcranial magnetic stimulation or neuromuscular electrical stimulation (NMS) |
| Comparison | Usual care |
| Outcomes | Any outcome reported in the paper. Upper Limb outcomes including:
|
13.4.1.1. Clinical evidence
Searches were conducted for systematic reviews and RCTs comparing the effectiveness of electrical stimulation (ES) to improve hand function for patients over 16 years old with stroke. Eighteen (18) RCTs were identified. Table 101 summarises the population, intervention, comparison and outcomes for each of the studies.
Table 101
Summary of studies included in the clinical evidence review. For full details of the extraction please see Appendix H.
Comparison: Electrical stimulation versus usual care
Table 102
Electrical stimulation versus usual care - Clinical study characteristics and clinical summary of findings.
Narrative summaries
The following studies are summarised as a narrative because the results were not presented in numerical data that could be included in the GRADE table:
- Cauraugh et al, 200038 found that the experimental group who received the FES training moved significantly more blocks and displayed a higher isometric force impulse after the rehabilitation treatment compared to usual care group. Neither Motor Assessment Scale nor Fugl-Meyer tests were significantly different between the two groups.
- Cauraugh et al, 200239 found significant findings favouring the coupled bilateral movement training and EMG-triggered neuromuscular stimulation group. In addition, the unilateral movement/stimulation group exceeded the control across the categories of tasks.
- Thrasher et al, 2008257 found that the FES group improved significantly more than the control group in terms of object manipulation, palmer grip torque, and pinch grip pulling force, Barthel Index, Upper Extremity Fugl-Meyer scores and Upper Extremity Chedoke-McMaster stages of Motor Recovery.
- Hara et al, 2008104 reported that the FES group displayed significantly greater improvements in the active Range of Movement of wrist and finger extension and shoulder flexion, modified Ashworth scale (MAS) and functional hand tests and was able to smoothly perform activities of daily life using the hemiplegic upper extremities.
13.4.1.2. Economic evidence
Literature review
No relevant economic evaluations comparing ES with usual care were identified.
Intervention costs
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
Typical costs for FES were obtained from Odstock Medical Limited at Salisbury District Hospital (by email, 20–21st December 2010) who supply the FES system described in the RCT reported by Mann et al (2005)168 included in the clinical review (the Microstim 2 [MS2v2], a self-contained two channel exercise stimulator). The cost of the MS2v2 kit is £267 (excluding VAT). The device is guaranteed for 2 years and spare parts and service maintenance are offered for a minimum of 5 years. The electrodes are single patient use and last around four weeks. Electrodes cost between £6 and £10 per pack of four (excluding VAT) depending on size and quality. The device will run on standard or rechargeable PP3 batteries (supplied in kit). The cost of a standard 6-month treatment package using the MS2v2 system consisting of one initial assessment and five treatment sessions is charged at £840; each session is £140. This includes the cost of all equipment, consumables, physiotherapy and hospital overheads and is delivered as an outpatient service. Patients can also use the MS2v2 daily in their own homes. Based on the standard treatment package cost, for FES to be judged cost effective it would need to provide benefits to patients that translated to at least an additional 0.042 QALYs per person.
13.4.1.3. Evidence statements
Clinical evidence statements
Two studies6,7 comprising of 41 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement in the Box and Blocs test at the end of the trial compared to participants who received usual care (LOW CONFIDENCE IN EFFECT).
One study137 comprising of 16 participants found no significant difference in the Box and Blocks test at the end of the trial between participants who received the Electrical Stimulation and those who received sham treatment (LOW CONFIDENCE IN EFFECT).
Two studies6,7 comprising of 41 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement in the Jebsen-Taylor Hand Function test (light cans) at the end of the trial compared to participants who received usual care (LOW CONFIDENCE IN EFFECT).
One study137 comprising of 16 participants found a statistically significant improvement in the Jebsen-Taylor Hand Function test (light cans) at the end of the trial for participants who received the Electrical Stimulation compared to those who received sham treatment (MODERATE CONFIDENCE IN EFFECT).
Two studies6,7 comprising of 41 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement in the Modified Fugl-Meyer Assessment at the end of the trial compared to participants who received usual care (VERY LOW CONFIDENCE IN EFFECT).
One study42 comprising of 20 participants found that participants received the Electrical Stimulation had significantly higher scores in the Functional Test for the Hemiplegic Upper Extremity at the end of the trial compared to the usual care group (MODERATE CONFIDENCE IN EFFECT).
One study42 comprising of 20 participants found no significant difference on the following outcomes between the Electrical Stimulation and the usual care groups at the end of the trial:
- forward reach distance (cm) (LOW CONFIDENCE IN EFFECT),
- active range of motion in wrist extension (VERY LOW CONFIDENCE IN EFFECT),
- grip power (kg) (LOW CONFIDENCE IN EFFECT),
- Functional Independence Measure (LOW CONFIDENCE IN EFFECT),
- Modified Ashworth Scale of shoulder (LOW CONFIDENCE IN EFFECT),
- Modified Ashworth Scale of elbow (LOW CONFIDENCE IN EFFECT),
- Modified Ashworth Scale of wrist (LOW CONFIDENCE IN EFFECT)
Two studies 42, 227 comprising 62 participants found no significant difference with the range of motion in wrist extension between the Electrical Stimulation and the usual care groups at the end of the intervention (HIGH CONFIDENCE IN EFFECT)
Three studies41;42; 227 comprising of 90 participants found no significant difference in the Functional Independence Measure between the Electrical Stimulation group and the usual care group post treatment (MODERATE CONFIDENCE IN EFFECT)
One study41 comprising of 28 participants found no significant difference in the Functional Independence Measure between the Electrical Stimulation group and the usual care group at 4 and 12 weeks follow-up (MODERATE CONFIDENCE IN EFFECT)
One study137 comprising of 16 participants found no significant difference on the following outcomes between the Electrical Stimulation and the usual care groups at the end of the trial:
- Strength of finger extension (LOW CONFIDENCE IN EFFECT),
- Motor Activity Log; amount of use score (LOW CONFIDENCE IN EFFECT),
- Motor Activity Log; how well used score (LOW CONFIDENCE IN EFFECT),
- Jebsen-Taylor Hand Function test (page turn) (LOW CONFIDENCE IN EFFECT),
- Jebsen-Taylor Hand Function test (heavy scans) (VERY LOW CONFIDENCE IN EFFECT).
One study117 comprising of 66 participants found statically significant improvement in the following outcomes between the Electrical Stimulation and the usual care groups
- Motor Activity Log: amount of use score – low dose (LOW CONFIDENCE IN EFFECT),
- Motor Activity Log: amount of use score – high dose (LOW CONFIDENCE IN EFFECT),
- Motor Activity Log: quality of movement – low dose (LOW CONFIDENCE IN EFFECT),
- Motor Activity Log: quality of movement – high dose (LOW CONFIDENCE IN EFFECT)
One study137 comprising of 16 participants found a statistically significant improvement in the following outcomes at the end of the trial for participants who received the Electrical Stimulation compared to those who received sham treatment:
- Jebsen-Taylor Hand Function test (small objects) (MODERATE CONFIDENCE IN EFFECT),
- Jebsen-Taylor Hand Function test (feeding) (MODERATE CONFIDENCE IN EFFECT),
- Jebsen-Taylor Hand Function test (stacking) (MODERATE CONFIDENCE IN EFFECT),
- Finger tracking accuracy test (LOW CONFIDENCE IN EFFECT).
One study210 comprising of 16 participants found a statistically significant improvement in the following outcomes for the higher functioning participants who received the Electrical Stimulation compared to those who received usual care:
- Upper Extremity Function Test (at the end of the trial and at 26 weeks follow-up) (MODERATE CONFIDENCE IN EFFECT),
- Drawing test (at the end of the trial and at 26 weeks follow-up) (LOW CONFIDENCE IN EFFECT),
- Ashworth grade (at 26 weeks follow-up) (MODERATE CONFIDENCE IN EFFECT),
- Reduced Upper Extremity Motor Activity Log Questionnaire- amount scale (at 26 weeks follow-up) (LOW CONFIDENCE IN EFFECT),
- Reduced Upper Extremity Motor Activity Log Questionnaire- how well scale (at 26 weeks follow-up) (LOW CONFIDENCE IN EFFECT).
One study210 comprising of 12 participants found a statistically significant improvement in the following outcomes for the lower functioning participants who received the Electrical Stimulation compared to those who received usual care:
- Upper Extremity Function Test (at the end of the trial and at 26 weeks follow-up) (MODERATE CONFIDENCE IN EFFECT),
- Drawing test (at 26 weeks follow-up) (LOW CONFIDENCE IN EFFECT),
- Reduced Upper Extremity Motor Activity Log Questionnaire- amount scale (at 26 weeks follow-up) (LOW CONFIDENCE IN EFFECT),
- Reduced Upper Extremity Motor Activity Log Questionnaire- how well scale (at 26 weeks follow-up) (LOW CONFIDENCE IN EFFECT).
One study117 comprising 66 participants found no difference in the change scores of Action Research Arm Test (total score) between the group that received low dose ES and the usual care group at 4 weeks follow up (LOW CONFIDENCE IN EFFECT).
One study117 comprising 66 participants found no difference in the change scores of Action Research Arm Test (total score) between the group that received high dose ES and the usual care group at 4 weeks follow-up (LOW CONFIDENCE IN EFFECT).
One study117 comprising 66 participants found a statistically significant improvement in the change scores of Action Research Arm Test (total score) between the group that received low dose ES and the usual care group at 12 weeks follow-up (LOW CONFIDENCE IN EFFECT).
Two studies168; 117 comprising of 88 participants found a statistically significant improvement in the change scores of Action Research Arm Test (total score) at 12 weeks follow-up for the participants who received the Electrical Stimulation compared to those who received usual care (LOW CONFIDENCE IN EFFECT).
One study168 comprising of 22 participants found a statistically significant improvement in the change scores of Action Research Arm Test (total score) at 24 weeks follow-up for the participants who received the Electrical Stimulation compared to those who received usual care (VERY LOW CONFIDENCE IN EFFECT).
Three studies 41,42;155 comprising of 85 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement (post treatment) in the Fugl-Meyer Assessment compared to participants who received usual care. This difference was of clinical importance (MODERATE CONFIDENCE IN EFFECT).
Three studies 41;117;155 comprising of 109 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement in the Fugl-Meyer Assessment compared to participants who received usual care at one month follow-up. This difference was of clinical importance (MODERATE CONFIDENCE IN EFFECT).
One study117 comprising of 66 participants found that participants who received low dose Electrical Stimulation experienced a statistically significant improvement in the Fugl-Meyer Assessment compared to participants who received usual care at one month follow-up. This difference was not of clinical importance (LOW CONFIDENCE IN EFFECT).
Three studies 41;117;155 comprising of 109 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement in the Fugl-Meyer Assessment compared to participants who received usual care at 3 months follow-up. This difference was of clinical importance (MODERATE CONFIDENCE IN EFFECT).
One study117 comprising of 66 participants found that participants who received low dose Electrical Stimulation experienced a statistically significant improvement in the Fugl-Meyer Assessment compared to participants who received usual care at 3 months follow-up. This difference was not of clinical importance (LOW CONFIDENCE IN EFFECT).
One study155 comprising of 46 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement in the Fugl-Meyer Assessment at 6 months follow-up compared to participants who received usual care. This difference was not of clinical importance (LOW CONFIDENCE IN EFFECT).
One study155 comprising of 46 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement post treatment and 1 month follow-up with the modified Ashworth scale compared to participants who received usual care (LOW CONFIDENCE IN EFFECT).
One study155 comprising of 46 participants found no significant improvement with the modified Ashworth scale at 3 months follow-up between the Electrical Stimulation and the usual care groups (VERY LOW CONFIDENCE IN EFFECT).
One study155 comprising of 46 participants found no significant improvement with the modified Ashworth scale at 6 months follow-up between the Electrical Stimulation and the usual care groups (LOW CONFIDENCE IN EFFECT).
One study155 comprising of 46 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement in the modified Barthel Index at post treatment and 1 month follow-up compared to participants who received usual care. This difference was not of clinical importance (LOW CONFIDENCE IN EFFECT).
One study155 comprising of 46 participants found that participants who received the Electrical Stimulation experienced a statistically significant improvement in the modified Barthel Index at 3 and 6 months follow-up compared to participants who received usual care (MODERATE CONFIDENCE IN EFFECT).
One study227 comprising 42 participants found no significant difference in electrophysiological evaluation (Fmax/Mmax) between the Electrical Stimulation and the usual care group (LOW CONFIDENCE IN EFFECT)
One study 227 comprising 42 participants found no significant difference in electrophysiological evaluation (Hmax/Mmax) between the Electrical Stimulation and the usual care group (HIGH CONFIDENCE IN EFFECT)
Economic evidence statements
No cost effectiveness evidence was identified.
13.4.2. Recommendations and link to evidence
| |
|---|---|
| Relative values of different outcomes | A wide range of measures were used in these studies and the GDG noted that there was no psychometrically robust patient-reported outcome measure used for assessment of reduced upper limb function. The wide range of measures reported within the trials reviewed makes interpreting the data difficult. |
| Trade-off between clinical benefits and harms | There are few risks associated with Electrical Stimulation. The commonest is a skin reaction when self-adhesive electrodes are used. Benefits arise from the increased range of movements produced by ES with the associated increased ease of performance of functional task. ES was typically targeted at finger and wrist extensors but was also used for elbow extension and shoulder flexion. The GDG were also aware of the use of electrical stimulation for management of spasticity however this was not included in review. |
| Economic considerations | No cost-effectiveness studies were found for this question. ES for hand functions are not routinely used in the UK NHS currently. A typical cost per patient of delivering ES was estimated to be around £840 (one initial assessment followed by five sessions in-hospital). Based on these costs, for ES to be judged cost effective it would need to provide benefits to patients that translated to at least an additional 0.042 QALYs per person. The GDG considered this additional benefit achievable in a selected population for whom the treatment is considered appropriate (for example people who have evidence of muscle contraction after stroke but cannot move their arm against resistance). |
| Quality of evidence | The majority of the studies reported benefit but this was not always significant. The GDG considered that the results should be interpreted with caution due to the small sample size of the studies. Very few studies reported follow-up results but Popovic210, Mann168, Powell213, Lin 155 did report statistical significance in favour of ES between 1 and six months follow-up for a range of outcomes including Fugl-Meyer Assessment and modified Barthel Index. The studies could be divided into those that looked at early after stroke, late after stroke and those that incorporated physiotherapy guided functional exercise and those that did not. The GDG observed that the Kimberley study 137 was the only one that did not have physiotherapy as the comparator and it was noted that generally the patients included in the studies tended to be the younger age group (between 45–70 years old). The GDG considered that when used early after stroke in high functioning people there appeared to be limited evidence of benefit 6,210 but a larger study is needed. The GDG also noted that the studies by Alon6,7 used a modified Fugl-Meyer Assessment outcome and therefore the results shown would need to be regarded with caution. |
| Other considerations | The GDG noted that the study by Alon6,7 was partially sponsored by the manufacturers of the device and that the results were consistent with other studies which were publicly or charity funded. Electrical stimulation is not widely available, and if a trial of treatment is offered to a patient it should only be delivered by a health professional with the appropriate skill set. The GDG agreed that an assessment of those who may benefit from the intervention should be carried out and a trial of use conducted to establish if an improvement in range of movement or function of the hand or wrist is clearly demonstrated. |
13.5. Constraint induced movement therapy
Constraint induced movement therapy is an approach to promote increased activity in the impaired upper limb in patients after stroke. In order to overcome ‘learned non-use’ in the affected limb the unaffected limb is restrained usually by a hand mitten or arm sling for long periods of the day, thereby promoting the use of the affected limb in everyday situations. In addition to the restraint, treatment includes periods of intensive focused exercise or activity usually under the guidance of a therapist. Because of the nature of the intervention constraint induced movement therapy is not suitable for, or acceptable to, all patients after stroke.
13.5.1. Evidence review: In people after stroke what is the clinical and cost effectiveness of constraint induced therapy versus usual care on improving function and reducing disability?
| Clinical Methodological Introduction | |
|---|---|
| Population | Adults and young people 16 or older who have had a stroke |
| Intervention | Constraint induced movement therapy (CIMT) for upper limb Subgroup analysis Less than 5 hours More than 5 hours Any constraint – e g slings |
| Comparison Outcomes | Usual care
|
13.5.1.1. Clinical evidence review
Searches were conducted for systematic reviews and RCTs comparing Constraint Induced Movement Therapies (CIMTs) with usual care for improving upper limb function and reducing disability in people after stroke. Only studies with a minimum sample size of 20 participants (10 in each arm) and including at least 50% of participants with stroke were selected. Fifteen (15) RCTs were identified. Table 1 summarises the population, intervention, comparison and outcomes for each of the studies.
Table 103
Summary of studies included in the clinical evidence review. For full details of the extraction please see Appendix H.
Comparison: constraint Induced movement therapies versus usual care
Table 104
Constraint induced movement therapy (CIMT) versus usual care - clinical study characteristics and clinical summary of findings.
Narrative summaries
The following studies are summarised as a narrative because the results were not presented in numerical data that could be included in the GRADE table:
- One study 102 randomised a convenient sample of 30 participants into forced-use training (N=15) and standard rehabilitation programme (N=15). The study found that the changes in the forced-use group did not differ from the changes in the standard rehabilitation group for any of the outcome measures (Fugl-Meyer Assessment and Action Research Arm Test). Both groups improved over time (post-treatment - 3 months follow-up), with statistically significant changes in the Fugl-Meyer Assessment (mean score changed from 52 to 57). The trial was unblinded and of a small sample size.
- In one study 206, 30 participants were randomly allocated to forced-use therapy and conventional therapy. Participants in the forced-use group had an 85% improvement (baseline = 20.7 (15.49)) in ARAT score, whereas those who received conventional therapy had a 74% improvement (baseline = 16.0 (13.64)) (p=0.20). No significant difference in FIM was observed (data not presented). None of the participants in the forced-use group achieved 6 hours of constraint wearing a day (average time = 2.7 hours/day). Data were presented as graphs and they could not be extracted/used for meta-analysis. The analysis was not done based on ITT and the study had unclear randomisation and allocation concealment.
13.5.1.2. Economic evidence
Literature review
No relevant economic evaluations comparing constraint induced movement therapy with usual care were identified.
Intervention costs
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
Looking at resources used in the studies included in the clinical review, the main difference in resources used between intervention and usual care was of the constraint used, with no substantial difference in personnel time. The GDG advised that the cost of constraint was minimal – for example it may involve using bandaging. However, the costs attributable to CIMT will depend on how and when it is offered. If CIMT activities are incorporated as part of the usual rehabilitation, costs may not be substantially higher than usual care; if CIMT is offered in addition to usual rehabilitation care that patients receive, additional costs would be incurred due to additional resource use (for example, staff time).
13.5.1.3. Evidence statements
Clinical evidence statements
Four studies72,182,197,270 of 159 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in Action Research Arm test compared to patients who received usual care at post-intervention, although it was not of clinical significance (LOW CONFIDENCE IN EFFECT).
One study270 of 66 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in Action Research Arm test compared to patients who received usual care at 4 weeks follow-up, although it was not of clinical significance (MODERATE CONFIDENCE IN EFFECT).
One study182 of 66 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in Action Research Arm test compared to patients who received usual care at 12 weeks follow-up (MODERATE CONFIDENCE IN EFFECT).
One study270 of 66 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in Action Research Arm test compared to patients who received usual care at 10 months follow-up, although it was not of clinical significance (MODERATE CONFIDENCE IN EFFECT).
Three studies54,254,294 of 115 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in Wolf Motor Function test performance time compared to patients who received usual care at post-intervention, although it was not of clinical significance (LOW CONFIDENCE IN EFFECT).
One study54 of 30 participants showed that there was no significant difference in performance time of the Wolf Motor Function test between those patients who received constraint induced movement therapy and those who received usual care at 6 months (LOW CONFIDENCE IN EFFECT).
One study 286 of 222 participants showed that patients who received constraint induced movement therapy showed statistically significant improvement in change in the Wolf Motor Function test performance time compared to patients who received usual care at 12 months (HIGH CONFIDENCE IN EFFECT).
Three studies54,254,294 of 115 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in functional ability of Wolf Motor Function test compared to patients who received usual care at post-intervention, although it was not of clinical significance (LOW CONFIDENCE IN EFFECT).
One study54 of 30 participants showed no significant difference in the functional ability of the Wolf Motor Function test between those who received constraint induced movement therapy and those who received usual care at 6 months (LOW CONFIDENCE IN EFFECT).
One study286 of 222 participants showed no significant difference in the change of the Wolf Motor Function test between those who received constraint induced movement therapy and those who received usual care at 12 months for the following scales:
- Functional ability (MODERATE CONFIDENCE IN EFFECT)
- Weight (MODERATE CONFIDENCE IN EFFECT)
- Grip (MODERATE CONFIDENCE IN EFFECT)
Five studies153,197, 154,292 (Lin 2009, Page 2008, Lin 2007 Wu 2007 (b)) of 160 participants showed that there was no statistically significant difference in the Functional Independence Measure (total score) between those patients who received constraint induced movement therapy and those who received usual care at post-intervention (LOW CONFIDENCE IN EFFECT).
One study54 of 30 participants showed no significant difference in the Functional Independence Measure (total score) between those who received constraint induced movement therapy and those who received usual care at 6 months (LOW CONFIDENCE IN EFFECT).
One study72 of 20 participants showed no significant difference in the following scales of the Functional Independence Measure between those who received constraint induced movement therapy and those 197 who received usual care at post intervention:
- eating (LOW CONFIDENCE IN EFFECT)
- Bathing (LOW CONFIDENCE IN EFFECT).
One study72 of 20 participants showed that patients who received constraint induced movement therapy showed statistically significant improvement in the following scales of the Functional Independence Measure compared to patients who received usual care at post intervention, although these differences were not of clinical significance:
- grooming (LOW CONFIDENCE IN EFFECT)
- upper extremity dressing (LOW CONFIDENCE IN EFFECT
Four studies153,197,291,292 of 138 participants showed that there was no statistically significant difference in Fugl-Meyer assessment between those patients who received constraint induced movement therapy and those who received usual care at post-intervention (LOW CONFIDENCE IN EFFECT).
One study270 of 66 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in Fugl-Meyer assessment compared to patients who received usual care at 3 weeks follow-up (HIGH CONFIDENCE IN EFFECT).
One study270 of 66 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in Fugl-Meyer assessment compared to patients who received usual care at 6 weeks follow-up, although it was not of clinical significance (MODERATE CONFIDENCE IN EFFECT).
One study270 of 66 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in Fugl-Meyer assessment compared to patients who received usual care at 1 year follow-up although it was not of clinical significance (MODERATE CONFIDENCE IN EFFECT).
Two studies72,182 of 68 participants showed that there was no statistically significant difference in Barthel Index between those patients who received constraint induced movement therapy and those who received usual care at post intervention (LOW CONFIDENCE IN EFFECT).
One study182 of 48 participants found that patients who received constraint induced movement therapy showed statistically significant improvement in Barthel Index between those patients who received constraint induced movement therapy and those who received usual care at 12 weeks follow-up, although it was not of clinical significance (LOW CONFIDENCE IN EFFECT).
One study182 of 48 participants showed that there was no statistically significant difference in Nine – hole Peg test between those patients who received constraint induced movement therapy and those who received usual care at post intervention (VERY LOW CONFIDENCE IN EFFECT).
One study182 of 48 participants showed that there was no statistically significant difference in Nine – hole Peg test between those patients who received constraint induced movement therapy and those who received usual care at 3 months follow-up (LOW CONFIDENCE IN EFFECT).
One study54 of 30 participants showed that there was no statistically significant difference in the experience of muscle tenderness in the affected arm between patients who received constraint induced movement therapy and those who received usual care (VERY LOW CONFIDENCE IN EFFECT).
Economic evidence statements
No cost effectiveness evidence was identified.
13.5.2. Recommendations and link to evidence
| |
|---|---|
| Relative values of different outcomes | The outcomes of interest included the Functional Independence Measure (FIM), Barthel Index, Fugl-Meyer score, Action Research Arm test (ARAT), Wolf Motor Function Test (WMFT) and 9 hole peg test. The 9 hole peg test may be insensitive as it is a measure of fine finger movements as well as the ability to reach. Similarly the FIM and Barthel Index as measures of dependence may be unresponsive to changes in upper limb function. The GDG noted that there is no psychometrically robust patient reported outcome measures focussing on upper limb activity. Any adverse event was also included where reported. |
| Trade-off between clinical benefits and harms | Participants who received constraint induced movement therapy (CIMT) demonstrated a clinically significant improvement in Fugl-Meyer scores at a short term of 3 weeks and in ARAT scores and functional ability of WMFT at 12 weeks follow-up. Although the improvement in performance time of WMFT for those who received CIMT was not of clinical significance at post intervention and at 6 months follow-up, the difference in this outcome became clinically significant between the participants in the CIMT and the usual care groups at 1 year follow-up. Only one study reported adverse events, the experience of muscle tenderness in the affected arm (Dahl, 2008) 54 during constraint induced movement therapy, though its prevalence was not significantly different between the two groups. However the GDG considered there were possible harms associated with this therapy and agreed that when selecting patients for CIMT, attention needs to be made to potential adverse events such as falling and deterioration in mood. |
| Economic considerations | No cost effectiveness studies were identified for this question. If CIMT activities are incorporated as part of the usual rehabilitation, costs may not be substantially higher than usual care. However, offering CIMT might represent a change in the usual activities that are part of the rehabilitation. The GDG agreed that it is unlikely that CIMT is offered in addition to usual rehabilitation care and therefore no additional costs would be incurred due to additional resource use. |
| Quality of evidence | The confidence in the effect for the outcomes of Functional Independence Measure, Barthel index, Wolf Motor Function Test, and 9- hole peg test ranged from high to very low due to limitations in study design (unclear allocation concealment and unclear randomisation) and imprecision around the effect estimate. The GDG acknowledged that due to the nature of the intervention it was difficult to recruit people into studies. The mean age of stroke survivors is 73–74 245 and it was noted that the patients within these studies, with the exception of the Wu study 2007 (b) 292, were relatively young for a stroke population and are likely to reflect those who are admitted into specialist rehabilitation units. In patients with movement of 20 degrees wrist and 10 degrees in fingers Constraint Induced Movement Therapy with repetitive task practice may be of benefit for patients both early (2 weeks after onset) and late after stroke. |
| Other considerations | The GDG agreed that the active element of constraint therapy is the amount of practice performed by the weak arm and this needs to be carefully structured and tailored to the individual patient needs. The GDG were unsure what value patients place on small improvements in upper limb function. Whilst this type of intervention may not be suitable or tolerated by some patients, the GDG agreed that it is an intervention that tends to be used with those patients who are highly motivated to get their movements back and it is these who would value this type of intervention most. |
13.6. Shoulder pain
There was a lack of direct evidence for the treatment of shoulder pain. Therefore recommendations in this section were based on modified Delphi consensus statements derived from published national and international guidance. This section of the Delphi survey was aimed at those Delphi panel members who felt they had the relevant experience to comment on shoulder pain. Other Delphi panel members could ‘opt out’ of this section. Response rates were therefore lower in this section. Below we provide tables of statements that reached consensus and statements that did not reach consensus and give a summary of how they were used to draw up the recommendations. For details on the process and methodology used for the modified Delphi survey see Appendix F.
13.6.1. How should people with shoulder pain after stroke be managed to reduce pain?
| Population | Adults and young people 16 or older who have had a stroke and have symptoms of shoulder pain |
|---|---|
| Components |
|
| Outcomes |
|
13.6.2. Delphi statements where consensus was achieved
Table 105Table of consensus statements, results and comments (percentage in the results column indicates the overall rate of responders who ‘strongly agreed’ with a statement and ‘amount of comments’ in the final column refers to rate of responders who used the open ended comments boxes, i.e. No. people commented/No. people who responded to the statement)
| Number | Statement | Results % | Amount (No. panel members who commented/No. panel members who responded) and content of panel comments – or themes |
|---|---|---|---|
| Information should be provided by the healthcare professional on how to prevent pain/trauma to the shoulder. | 77.6 | 7/49 (14%) panel members commented Most panel members who commented on this question queried who to give the information to (patient, carer, other staff) and under which conditions (if there is weakness in the shoulder). It was stated in one comment that there was no information available on this topic. | |
| 1. | When managing shoulder pain the following treatments should be considered:
| 70.7 | In round 2 - 23/49 (47%) panel members commented; 13/42(31%) in round 3 None of the other treatment options gained consensus the options were:
|
13.6.3. Delphi statement where consensus was not reached
Table 106Table of ‘non-consensus’ statements with qualitative themes of panel comments
| Number | Statement | Results % | Amount and content of panel comments – or themes |
|---|---|---|---|
| 1. | The person who has had a stroke should be assessed for shoulder pain | 63.6 | In round 2 - 13/48 (27%) panel members commented; 7/42(17%) in round 3 There was a general opinion that this should be easily ascertained and therefore a full assessment is not needed. |
| 2. | There is a need for an algorithm to assess and treat shoulder pain | 31.0 | In round 2 - 23/49 (47%) panel members commented; 13/42(31%) in round 3 Some comments were made that there are algorithms already in existence. Others commented that the evidence for treatments was poor and therefore there is not enough information to create an algorithm. There were also comments that this would be useful. |
13.6.4. Recommendations and links to Delphi consensus survey
| Statements |
|
|---|---|
| Recommendation |
|
| Economic considerations | There is a minor cost of staff time associated with the provision of information. However the GDG considered these to be largely offset by the benefits. |
| Other considerations | The GDG agreed this was a common problem amongst people after stroke and that prevention should be highlighted. However, the means of preventing shoulder pain is not universally agreed and this may be due, to the large array of identified causes, including spasticity, thalamic (central) pain, complex regional pain syndromes (CRPS), (for example: shoulder-hand syndrome), fracture and soft-tissue problems. It is generally agreed that one of the major causes of injuring the shoulder is poor manual handling and support of the at-risk arm by health professionals, carers, or the patient themselves. In the survey consensus was reached only for providing information to prevent shoulder pain. The GDG clarified this statement by indicating the people likely to develop shoulder pain were those with changes in tone or power in their arms. Algorithms and assessments did not reach consensus in the Delphi and the GDG discussed the pros and cons of including this in a list of assessments routinely carried out. It was felt that asking people who display discomfort when moving their arms would be sufficient in the majority of cases. Whilst there was consensus that positioning the shoulder may help to alleviate symptoms, overall the view from the survey showed there was no evidence base to recommend any particular treatment. The GDG agreed this was an area where further research was needed to assess the effectiveness of the various management strategies currently used, and agreed that a research recommendation be included in the guideline. The GDG were surprised that there was no agreement about the use of a simple treatment such as analgesics to alleviate pain. The group agreed that whilst it was not possible to make a recommendation, health professionals should consider other treatments according to individual need. The GDG acknowledged that a varied range of therapies were currently being used in practice that include: upper limb support including slings and orthotics, strapping of the shoulder, range of motion exercises, ultrasound, electrical stimulation, steroid and botulinum toxin injections, acupuncture and massage therapy. The use of shoulder slings may be associated with some risks, including holding the limb in a poor position that is likely to cause soft tissue contracture, inhibiting use of a recovering limb, and have an adverse effect on symmetry and balance, making falls more likely. |
13.7. Repetitive task training
Rehabilitation is integral to the care pathway after stroke. However the optimum components of physical rehabilitation are uncertain. Repetitive task training promotes the repetition of motor movement related to purposeful tasks. This might for example include reaching for a cup or combing hair. The focus is generally on the impaired limb and is one approach to increase the amount of physical rehabilitation.
13.7.1. Evidence review: In people after stroke what is the clinical and cost effectiveness of repetitive task training versus usual care on improving function and reducing disability?
| Clinical Methodological Introduction | |
|---|---|
| Population | Adults and young people 16 or older who have had a stroke |
| Intervention |
|
| Comparison | Usual care |
| Outcomes | Lower limb
Arm:
|
13.7.1.1. Clinical evidence
Searches were conducted for systematic reviews and RCTs comparing the clinical effectiveness of repetitive task training with usual care to improve function and reduce disability for adults and young people 16 or older who have had a stroke. Only studies with a minimum sample size of 20 participants (10 in each arm) were selected. Five RCTs were identified.
Table 107 summarises the population, intervention, comparison and outcomes for each of the studies.
Table 107
Summary of studies included in the clinical evidence review. For full details of the extraction please see Appendix H.
Comparison: lower limb training (repetitive task or functional) versus usual care
Table 108
Lower limb training (repetitive task or functional) versus usual care - Clinical study characteristics and clinical summary of findings.
Comparison: Upper limb training (repetitive task or functional) versus usual care
Table 109
Upper limb training (repetitive task or functional) versus usual care - Clinical study characteristics and clinical summary of findings.
13.7.1.2. Economic evidence
Literature review
No relevant economic evaluations comparing repetitive task training with usual care were identified.
Intervention costs
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
In the RCTs included in the clinical review a substantial difference in terms of personnel time was not seen between usual care and repetitive task training. Some negligible costs would be linked with the use of cards that patients were asked to manipulate (for example, in Higgins 2002111). However, the GDG noted that this was due to the studies ‘matching’ the intensity of input; in real life it was expected that repetitive task training might involve some additional therapy time or that carers would be trained to assist.
13.7.1.3. Evidence statements
Clinical evidence statements
Two studies27,229 of 121 participants showed that there was a statistically significant improvement in locomotor performance assessed by the 6 minute walk test (m) in the group that received mobility/lower limb training, compared with the usual care group at the end of the treatment (LOW CONFIDENCE IN EFFECT).
One study27 of 30 participants showed no significant difference in locomotor performance assessed by the 6 minute walk test (m) between the mobility/lower limb training group and the usual care group at 6 months follow-up (LOW CONFIDENCE IN EFFECT).
Two studies27,229 of 121 participants showed a statistically significant improvement in the Timed Up and Go Test (sec) for the group received the lower limb training compared to the usual care group at the end of the treatment (LOW CONFIDENCE IN EFFECT).
One study27 of 30 participants showed no significant difference in locomotor performance assessed by the Timed Up and Go Test (sec) between the mobility/lower limb training group and the usual care group at 6 months follow-up (LOW CONFIDENCE IN EFFECT).
Two studies140,229 of 159 participants found a significant difference in comfortable and maximum walking speed measured by 5 and 10 m timed walk (m/sec) between those who received mobility/lower limb training and the usual care group at the end of the treatment (MODERATE CONFIDENCE IN EFFECT).
One study140 of 68 participants showed no significant difference in comfortable and maximum walking speed measured by 5 and 10 m timed walk (m/sec) between those who received mobility/lower limb training and the usual care group at 6 ½ months follow-up (LOW CONFIDENCE IN EFFECT).
One study111 of 91 participants found no significant difference in the 9 hole peg test scores between the arm training group and the usual care group at the end of the treatment (MODERATE CONFIDENCE IN EFFECT).
One study285 of 33 participants showed that the standard care group was associated with a statistically significant improvement in the Fugl-Meyer assessment (range of motion), compared with those who received functional task arm training at the end of treatment (VERY LOW CONFIDENCE IN EFFECT).
One study285 of 33 participants showed no significant difference between the functional task arm training group and the usual care group at the end of the treatment on the following outcomes:
- Fugl-Meyer assessment (pain) (VERY LOW CONFIDENCE IN EFFECT)
- Fugl-Meyer assessment (sensory) (VERY LOW CONFIDENCE IN EFFECT)
One study285 of 33 participants showed that the functional task arm training group was associated with a statistically significant improvement in the Fugl-Meyer assessment (motor function) compared with those who received usual care at the end of the treatment (LOW CONFIDENCE IN EFFECT).
One study285 of 33 participants found no significant difference between the functional task arm training group and the usual care group at 9 months follow-up on the following outcomes:
- Fugl-Meyer assessment (range of motion (VERY LOW CONFIDENCE IN EFFECT)
- Fugl-Meyer assessment (pain) (VERY LOW CONFIDENCE IN EFFECT)
- Fugl-Meyer assessment (sensory) (VERY LOW CONFIDENCE IN EFFECT)
- Fugl-Meyer assessment (motor function) (VERY LOW CONFIDENCE IN EFFECT)
Evidence statements could not be produced for the following outcome(s) as results were not presented in a way that enabled the size of the intervention’s effect to be estimated:
Economic evidence statements
No cost effectiveness evidence was identified.
13.7.2. Recommendations and link to evidence
| Recommendations: |
|
|---|---|
| Relative values of different outcomes | All the repetitive tasks considered in the review comprised of circuit type tasks for upper and lower limb. Other types of repetitive task such as dressing practice or treadmill were not identified by the search. The outcomes of interest for the lower limb were any timed walk, change in walking distance and Rivermead Mobility Index. As there were a variety of different timed walk measures the GDG requested that the results be presented together as no greater emphasis would be placed on one over another. The GDG agreed to use the following minimal important differences (MIDs) published in the literature for the following outcomes reported; 20 cm/sec for the walking speed, 12 and 17 points for the affected dominant and non-dominant sides respectively when assessing the outcome of Action Research Arm (ARAT) and difference by 10% of the total scale for the Fugl-Meyer assessment (FMA) (please refer to Table 5 in the methodology chapter for more details on the published sources of the agreed minimal important differences). |
| Trade-off between clinical benefits and harms | The GDG agreed there were no significant harms associated with these interventions. The consensus of the GDG was that repeated practice for both upper and lower limb functions was likely to be beneficial in terms of patients’ quality of life and social inclusion. |
| Economic considerations | No relevant cost effectiveness evidence was identified. The clinical studies included in the review did not indicate a difference in resource use between repetitive task training and usual care; however, it was considered that in reality there may be some additional personnel time, therefore costs associated with repetitive task training. The GDG considered these costs to be offset by the benefits. |
| Quality of evidence | The GDG noted that two of the studies included in the review (Salbach, 2004 and Higgins 2002) are the same study with one reporting upper extremity intervention results and the other mobility. Two studies showed a significant improvement in the 6-minute walk test (Blennerhassett, 2004 and Salbach, 200527,229) and two in the timed metres walks (Kwakkel, 1999 and Salbach, 2004 140,229). The GDG noted that this improvement was found at the end of the study (post treatment effect) but not at 6 months follow-up (Kwakkel, 1999140), however it would usually be expected that once patients were walking this would be maintained. The lower limb outcomes were graded between low and moderate due to study limitations and imprecision around the effect estimate. The Winstein (2004) study demonstrated that functional task arm training was associated with a significant improvement with motor function compared to usual care group at the end of treatment. Confidence in the results for these outcomes was graded as very low due to limitations in study design (inadequate allocation concealment and randomisation) and the effect estimate not reaching the minimal important difference of 10% of the scale. However this improvement in the motor ability outcomes was not preserved at 9 months follow-up. It was not possible to estimate the size of effect of the upper limb interventions within the Kwakkel and Blennerhassett studies as results were presented only as medians (IQR). |
| Other considerations | The GDG considered that the interventions used for upper limb which included tasks such as manipulating playing cards and handwriting are not representative of usual therapeutic interventions. However the GDG believed such tasks are important in terms of enabling the patient to undertake activities themselves and promoting participation and self- esteem. The GDG agreed that although useful for some patients these are high level tasks. The GDG agreed that the trials included those people who already had some upper limb function, and that this is the group who are most likely to benefit from the interventions. |
13.8. Walking therapies: treadmill and treadmill with body weight support
There are two types of treadmill training that are currently used to assist with the re-education of gait following a stroke. The first is a conventional treadmill that requires the stroke survivor to mobilise bearing the full weight of their body. The second is a treadmill with body weight support that allows the stroke survivor to mobilise without requiring that they carry the full weight of their body. As they become stronger they are able to gradually reduce the body weight support. The use of treadmill training both with and without body weight support has been shown to assist with the re-education of gait following stroke, as an adjunct to conventional physiotherapy. It has not been demonstrated to be of benefit instead of routine physiotherapy intervention.
13.8.1. Evidence review: In people after stroke what is the clinical and cost-effectiveness of all treadmill versus usual care on improving walking?
13.8.2. Evidence review: In people after stroke who can walk, what is the clinical and cost effectiveness of treadmill plus body support versus treadmill only on improving walking?
| Clinical Methodological Introduction | |
|---|---|
| Population | Adults and young people 16 or older who have had a stroke |
| Intervention | Any treadmill training (with or without body support) |
| Comparison |
|
| Outcomes |
|
13.8.2.1. Clinical evidence review
Searches were conducted for systematic reviews (of randomized controlled trials (RCTs) and cohort studies) and RCTs that compared the effectiveness of all treadmill therapies with usual care to improve walking for adults and young people 16 or older who have had a stroke. Only studies with a minimum sample size of 20 participants (10 in each arm) and including at least 50% of participants with stroke were selected. Sixteen (16) RCTs were identified. One study 190 included treadmill training exercise with body support compared to usual care and three studies 15,115,272 compared treadmill training exercise with body support with treadmill training exercise without body support. All the other studies compared treadmill without body weight support versus usual care. Table 110 summarises the population, intervention, comparison and outcomes for each of the studies included in the clinical evidence review.
Table 110
Summary of studies included in the clinical evidence review. For full details of the extraction please see Appendix H.
Comparison: Treadmill training (with or without body support) versus usual care
Table 111
All treadmill training (with or without body support) versus usual care - Clinical study characteristics and clinical summary of findings.
Comparison: Early treadmill training exercise (2 months after stroke) with body weight support versus home exercise program
Table 112
Early treadmill training exercise (2 months after stroke) with body weight support versus home exercise program – Clinical study characteristics and clinical summary of findings.
Comparison: Treadmill training exercise with body support versus treadmill training exercise without body support
Table 113
Treadmill plus body weight support versus treadmill only - Clinical study characteristics and clinical summary of findings.
13.8.2.2. Economic evidence
Literature review
No relevant economic evaluations were identified comparing treadmill training with usual care, or treadmill training with body support with treadmill training without body support.
Intervention costs
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
In most studies identified in the clinical review the main difference in terms of resources use between treadmill training and usual care was the use of the treadmill and there was no substantial difference in personnel time. Illustrative treadmill costs are presented below.
A GDG member supplied price data on a specific type of treadmill without body support unit. This data was obtained from the manufacturer of the treadmill (Cranlea & Co Medical). The treadmill model was a Woodway model desmohip, and its cost amounted to £9,421 (2011 prices), with an additional £500 estimated as delivery and installation costs. The GDG also supplied data regarding the rate of utilisation of a treadmill without body weight support for an NHS Trust with an inpatient sub-acute stroke rehabilitation service (based at Guy’s and St Thomas’ NHS Foundation Trust) where patients are usually 0–60 days post stroke. The treadmill alone is used to the level of approximately 2–4 treatment sessions each day, where each session lasts for about 1 hour. Annuitising this cost assuming a useful lifetime of 5 years, no resale value and a discount rate of 3.5%, and assuming usage of 3 sessions per day, this would equate to a cost per session of £1.94.
The estimate for the cost of a treadmill with body weight support was obtained by contacting the author of a US study (Walker, 2010279).The overall cost quoted by the author was of $20,000 (of which $2,000 was the cost of the treadmill alone), equivalent to £13,029 (at 2009 prices). The manufacturer of the treadmill and of the BSW unit was Biodex (a US company). A GDG member supplied data regarding the rate of utilisation of a treadmill with body weight support for an NHS Trust with an inpatient sub-acute stroke rehabilitation service (based at Guy’s and St Thomas’ NHS Foundation Trust) where patients are usually 0–60 days post stroke. The treadmill with BWS unit is used for approximately 1 patient per month for approximately 4–6 treatments overall. Annuitising this cost assuming a useful lifetime of 5 years, no resale value and a discount rate of 3.5%, and assuming usage of 5 sessions per month, this would equate to a cost per session of £46.47.
13.8.2.3. Evidence statements
Clinical evidence statements
Two studies74, 143 of 83 participants with acute stroke found that there was no significant difference in walking capacity (6 minute walk test) (m) between the participants who received treadmill training with no body weight support and those who had usual care at the end of the study (MODERATE CONFIDENCE IN EFFECT).
Three studies 193 94,131 of 100 participants with chronic stroke (up to 24 months post-stroke) found that there was no significant difference in walking capacity (6 minute walk test) (m) between those who received treadmill training without body weight support and the usual care group at the end of the study (LOW CONFIDENCE IN EFFECT).
One study74 of 49 participants found that treadmill training with no body weight support was associated with a statistically significant improvement in walking capacity (6 minute walk test) (m) compared to those receiving usual care at the end of the 18 weeks follow-up (MODERATE CONFIDENCE IN EFFECT).
Four studies74,143,147,208 comprising of 148 participants with acute stroke found a statistically significant improvement in gait speed (10 metre timed walk test)(m/sec) in those who received treadmill training with no body weight support compared to those who received usual care at the end of the study (LOW CONFIDENCE IN EFFECT).
Three studies 193 94,131 of 100 participants with chronic stroke (up to 24 months post-stroke) found a statistically significant larger improvement in gait speed (10 metre timed walk test) (m/sec) in those who received treadmill training, compared to those who received usual care at the end of the study (MODERATE CONFIDENCE IN EFFECT).
Two studies74,190 comprising of 102 participants found no significant difference in gait speed (10 metre timed walk test) (m/sec) between the all treadmill training group (with and without body weight support) and those who received usual care at the end of the follow-up (average 29 weeks) (MODERATE CONFIDENCE IN EFFECT).
One study138 comprising of 56 participants found no significant difference between the partial body weight support treadmill group and those who received aggressive bracing assisted walking at the end of the study on the following outcomes:
- walking speed over a 2-minute test period (m/minute)(VERY LOW CONFIDENCE IN EFFECT)
- walking endurance (m) (VERY LOW CONFIDENCE IN EFFECT).
One study190 comprising of 60 participants found no significant difference between the treadmill training group with body weight support and those who received usual care at 10 months follow-up on the following outcomes:
- FIM motor items (LOW CONFIDENCE IN EFFECT)
- FIM cognitive items (LOW CONFIDENCE IN EFFECT).
One study139 comprising of 30 participants found no significant difference between the participants received the treadmill training group and those who received usual care at 6 and 18 months follow-up on the following outcomes:
- walking endurance (LOW CONFIDENCE IN EFFECT)
- comfortable walking speed (m/sec) (LOW CONFIDENCE IN EFFECT)
- fast walking speed (m/sec) (LOW CONFIDENCE IN EFFECT).
One study73 comprising of 265 participants found that there was significant difference between the participants who received early body weight supported treadmill training and those who received home exercise program on the following outcomes:
- 10 metre timed walk test (m/sec) at the end of the study and 6 months follow-up (MODERATE CONFIDENCE IN EFFECT)
- 6 minute walk test (m) at the end of the study and 6 months follow-up (MODERATE CONFIDENCE IN EFFECT)
Two studies272, 115 comprising of 139 participants found no significant difference (in 10 metre timed walk test) between the participants who received body weight supported treadmill training and those who received only treadmill training post intervention (MODERATE CONFIDENCE IN EFFECT)
Two studies272, 115 comprising of 139 participants showed significant difference in 10 metre timed walk test in favour of the participants who received body weight supported treadmill training compared with those who received only treadmill training at the end of follow-up (VERY LOW CONFIDENCE IN EFFECT)
One study272 comprising of 100 participants found no significant difference between the participants who received body weight supported treadmill training and those who had only treadmill training on the following outcomes:
- walking endurance (m) at the end of the study (VERY LOW CONFIDENCE IN EFFECT)
- walking endurance (m) at 3 months follow-up (VERY LOW CONFIDENCE IN EFFECT).
One study15 comprising of 100 participants found that there was no significant difference on the proportion of participants achieved over ground walking speed over 0.2 m/s between those who received body weight supported treadmill and those who had only treadmill training (VERY LOW CONFIDENCE IN EFFECT).
One study15 comprising of 100 participants found that there was no significant difference on the proportion of participants achieved over ground walking endurance over 20 m between those who received body weight supported treadmill and those who had only treadmill training (LOW CONFIDENCE IN EFFECT).
One study 115 comprising 60 participants found no significant difference (in 6 metre walk test) between the group that received body weight treadmill and the group that received only treadmill post intervention and at the end of follow-up (LOW CONFIDENCE IN EFFECT)
One study 115 comprising 60 participants found no significant difference (in the Functional Independence measure scales 9 and 13) between the group that received body weight treadmill and the group that received only treadmill post intervention and at the end of follow-up (VERY LOW CONFIDENCE IN EFFECT)
Evidence statements could not be produced for the following outcome(s) as results were not presented in a way that enabled the size of the intervention’s effect to be estimated:
Economic evidence statements
No cost-effectiveness evidence was identified.
13.8.3. Recommendations and link to evidence
| |
|---|---|
| Relative values of different outcomes | The outcomes considered in the evidence review were: walking speeds (5 m/ 10 m / 30 m), timed walk, walking endurance, FIM, Barthel and Rivermead Mobility Index. The GDG considered outcomes demonstrating changes in walking to be of more significance. Overall, the sixteen (16) studies included in the review showed there was an improvement in walking outcomes in both the intervention and control groups, but treadmill provided no greater improvement than other forms of physiotherapy. |
| Trade-off between clinical benefits and harms | The patient representatives on the group felt that too much emphasis was being placed on distance and speed, and that for patients, the primary concern was the motivation to walk from point A to B safely and feeling comfortable. They felt that speed of walking would not be a significant concern of patients. Group members noted that the trials were conducted in a gym setting and this would not necessarily translate to walking outdoors. The consensus view was that variety was an important part of rehabilitation treatment for patients, and treadmill is a reasonable tool for use in gait training for people who are already walking and can increase walking speed and capacity. |
| Economic considerations | No relevant cost effectiveness studies were identified. The main difference in cost of using treadmill training over usual care was considered to be the cost of the treadmill. The capital cost of a treadmill is high at around £10,000, however when this cost is spread over the lifetime of the equipment and the amount of usage it gets the cost per patient per session was estimated at £2 for treadmill without body weight support, and £47 for treadmill with body weight support. The GDG also noted that a treadmill may already be available in many hospitals and used for purposes other than stroke rehabilitation; if currently not fully utilised, use in stroke patients could be accommodated without incurring the full costs estimated. |
| Quality of evidence | All the studies were small (range of participants in the included studies 25–113). The studies using both the 6 minute walk test and 10 metre timed walk as measurements over different follow-up periods present mixed results but overall showed no significant difference between the intervention arm (treadmill with or without body weight) and the control arm in walking capacity or gait speed outcomes. Confidence in the results for walking capacity and speed outcomes was moderate to very low due to limitations in study design or imprecision in the effect estimate. The GDG noted that all the people within the studies had some walking capacity except for one trial 86. The GDG questioned why the results in the Visintin study (1998) showed there was late gain achieved in the 10 metre walk outcome when there was no immediate response after the intervention. After discussion, the GDG concluded that it may be that with body support better gait is achieved and therefore this would explain the late gain. There were also differences in gait speed between the two groups which may have allowed the intervention arm to reach a certain threshold. The GDG concluded that the patients within the trials used in the clinical evidence could already walk with some support; therefore the recommendation should state that this group are most likely to benefit from treadmill. |
| Other considerations | Treadmill facilities are widely available in rehabilitation units and the GDG agreed that treadmill was one method of delivering an intensive treatment. As treadmill was found to be as good as conventional therapy the GDG agreed it could be considered for patients. Patients currently would usually receive fixed amounts of therapy which includes treadmill training as part of their rehabilitation therapy. If patients are stable then treadmill users can work with minimal supervision once they are set up on the equipment. Treadmill enables patients to get much more practice walking than they can by walking outdoors and it also offers the opportunity to do forced speed training. The GDG agreed that treadmill was a useful tool and offered some benefit to the patients after stroke even if no greater than usual care. The GDG agreed that it was important for everyone to be offered walking training, and this was backed up by the evidence reviewed which showed both arms of studies making an improvement following walking exercises. |
13.9. Electromechanical gait training
An electromechanical gait trainer is a robotic gait assistive device that is designed to provide physical support and mechanical walking action during gait re-education. There are several types of electromechanical gait training interventions that provide repetitive locomotor therapy. Locomat and Reha-stim are the trade-names of the trainers used in the studies considered. Both are robotic, or servo controlled motor assisted devices, and provide variable amounts of assistance during walking training, including timing of leg movements with the option of body weight support (up to 40%). The advocates of electromechanical gait trainers claim that it improves walking by stimulating a normal, symmetrical gait cycle.
Asymmetrical muscle weakness, tonal changes, loss of sensation including proprioception, and poor balance and coordination are major obstacles in the successful rehabilitation of gait in the recovering stroke patient. The use of assistive devices such as electromechanical gait trainer aims to assist in the re-education of gait through supported repetition of walking behaviour.
The use of the aid is assumed to be in the context of a professionally directed rehabilitation programme to improve walking ability. A suitably qualified Physiotherapist and assistant will be required to design the appropriate walking training, position the patient correctly and to encourage and advise throughout the duration of the intervention.
This type of intervention may be used throughout any stage in the rehabilitation following stroke as long as the patient is medically fit and has no contraindications to exercise.
Due to the cost and scarcity of the equipment this form of intervention is rarely seen within NHS facilities.
13.9.1. Evidence review: In people after stroke what is the clinical and cost effectiveness of electromechanical gait training versus usual care on improving function and reducing disability?
| Clinical Methodological Introduction | |
|---|---|
| Population | Adults and young people 16 or older who have had a stroke |
| Intervention | Electromechanical gait training Locomat training |
| Comparison | Usual care |
| Outcomes |
|
13.9.1.1. Clinical evidence review
Searches were conducted for systematic reviews and RCTs comparing the effectiveness of electromechanical gait training with usual care as interventions for improving function and reducing disability for adults and young people 16 or older who have had a stroke. Only studies with a minimum sample size of 20 participants (10 in each arm) and including at least 50% of participants with stroke were selected. Eleven RCTs were identified. Table 114 summarises the population, intervention, comparison and outcomes for each of the studies.
Table 114
Summary of studies included in the clinical evidence review. For full details of the extraction please see Appendix H.
Comparison: Electromechanical gait training versus usual care
Table 115
Electromechanical gait training versus usual care - Clinical study characteristics and clinical summary of findings.
One RCT (Morone 2012179) stratified participants with stroke according to their initial motor impairment levels into separate groups from the outset. Results of this trial are presented in a separate GRADE table since overall values were not provided.
Comparison: Electromechanical gait training versus conventional gait training (in groups stratified by level of motor impairments)
Table 116
GRADE characteristics and clinical summary of findings. (Note. LM=low motricity – greater level of impairments; HM= high motricity – lower level of impairment)
Narrative summary
The following study is summarised as a narrative because the results were not presented in numerical data that could be included in the GRADE table:
- One study 203 randomised 56 patients to gait trainer exercise, walking training and conventional treatment. At the end of 3 weeks training, mean walking velocity (10 metre timed walk test) and walking distance (6 minute walk test) were not different between the gait trainer exercise and walking groups (10 metre timed walk test, p=0.452; 6 minute walk test, p=0.547). The Rivermead Mobility Index improved in all groups (from baseline to end of treatment) but p value for group difference was not statistically significant (p=0.703). Analysis was based on the number of patients who were able to walk 20 minutes (different level of patients’ participation in different measurements at different time points) and reconstructed data for 10 metre timed walk test and 6 minute walk test was used; therefore this study was not included in the meta-analysis.
13.9.1.2. Economic evidence
Literature review
No relevant economic evaluations comparing electromechanical gait training with usual care were identified.
Intervention costs
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
The manufacturers of Lokomat and of Reha-Stim electromechanical gait trainers were contacted and they each supplied costs for their products. The Lokomat electromechanical gait trainer costs ranged between ~£173,000 to ~£264,000 (costs provided by Hocoma by email, 20th June 2011; VAT is excluded). The Reha-Stim electromechanical gait trainer cost was provided but is not reported here as it was deemed commercial in confidence. Assuming a discount rate of 3.5%, a life expectancy for the machine of 10 years, a utilization rate of the machine of 208 days per year and of 4 hours each day, for an intervention consisting of 6 hours of use of the electromechanical gait training, the attributable cost for the intervention using a Lokomat trainer would be between ~£145 and ~£221. To these costs it may be necessary to add personnel costs when the patient needs to be aided in using the electromechanical gait trainer.
13.9.1.3. Evidence statements
Clinical evidence statements
Six studies 114,118,204,209,260,281 of 344 participants found no significant difference in 5 and 10 metre timed walk test (m/sec) between the electromechanical gait training group and the usual care group at the end of the intervention (LOW CONFIDENCE IN EFFECT).
One study 110 of 72 participants found that those who received usual care was associated with a statistically significant improvement in 5 metre timed walk test (m/sec) compared with the electromechanical gait training group at the end of the intervention (LOW CONFIDENCE IN EFFECT).
One study 110 of 72 participants found that those who received usual care was associated with a statistically significant improvement in 5 and 10 metre timed walk test (m/sec) than the electromechanical gait training group, at 3 months follow-up (LOW CONFIDENCE IN EFFECT).
One study 114 of 62 participants (>6 months post-stroke) found no significant difference in 5 and 10 metre timed walk test (m/sec) between the electromechanical gait training group and the usual care group at the end of 6 months follow-up (LOW CONFIDENCE IN EFFECT).
One study 209 of 155 participants (<2 months post-stroke) found that the electromechanical gait training group was associated with a statistically significant improvement in 10 metre timed walk test (self-selected) (m/sec) compared with the usual care group at the end of 6 months follow-up (LOW CONFIDENCE IN EFFECT).
Four studies 64,114,204,209 of 287 participants found no significant difference in 6 minute walk test (m) between the electromechanical gait training and the usual care group at the end of intervention (LOW CONFIDENCE IN EFFECT).
One study 110 of 72 participants found that those who received usual care was associated with a statistically significant greater improvement in 6 minute walk test (m) compared with the electromechanical gait training group at the end of intervention (LOW CONFIDENCE IN EFFECT).
One study 110 of 72 participants found no significant difference in 6 minute walk test (m) (self-selected) between the electromechanical gait training and the usual care group at 3 months follow-up (LOW CONFIDENCE IN EFFECT).
One study 114 of 62 participants (>6 months post-stroke) found no significant difference in 6 minute walk test (m) between the electromechanical gait training and the usual care group at 6 months follow-up (VERY LOW CONFIDENCE IN EFFECT).
One study 209 of 155 participants (<60 days post-stroke) found that those who received electromechanical gait training was associated with a statistically significant greater improvement in 6 minute walk test (m) compared with those who received usual care at 6 months follow-up (LOW CONFIDENCE IN EFFECT).
One study 204 of 30 participants found no significant difference in total Functional Independence Measure between the electromechanical gait training and the usual care group at the end of intervention (VERY LOW CONFIDENCE IN EFFECT).
One study 233 of 67 participants found no significant difference in Functional Independence Measure (Motor item) between electromechanical gait training and usual care at the end of intervention (LOW CONFIDENCE IN EFFECT).
Three studies 64,110,209 of 267 participants found that electromechanical gait training was associated with a statistically significant improvement on the Rivermead Mobility Index compared with the usual care group at the end of intervention (LOW CONFIDENCE IN EFFECT).
One study 110 of 72 participants found that electromechanical gait training was associated with a statistically significant improvement on the Rivermead Mobility Index compared with those who received usual care at 3 months (LOW CONFIDENCE IN EFFECT)
One study 209 of 155 participants found that electromechanical gait training was associated with a statistically significant improvement on the Rivermead Mobility Index compared with those who received usual care at 6 months follow-up (MODERATE CONFIDENCE IN EFFECT).
One study 209 of 155 participants found that electromechanical gait training was associated with a statistically significant improvement on Barthel Index compared with those who received usual care at the end of intervention (MODERATE CONFIDENCE IN EFFECT) and 6 months follow-up (MODERATE CONFIDENCE IN EFFECT).
Electromechanical gait training versus conventional gait training in groups divided by initial motor impairment level
One study179 of 48 participants found that robotic gait training significantly improved functional ambulatory abilities (as measured by the Functional Ambulation Classification scale) in those with higher levels of motor impairments (at baseline). These improvements were observed both at discharge and at 2 year follow-up compared to conventional gait training. However, these improvements were not observed in participants with fewer impairments (at baseline).
One study179 of 48 participants found that robotic gait training significantly improved performance in activities of daily living (as measured by the Barthel Index) in those with higher levels of motor impairments (at baseline). These improvements were observed both at discharge and at 2 year follow-up compared to conventional gait training. However, these improvements were not observed in participants with fewer impairments (at baseline).
One study179 of 48 participants found that robotic gait training significantly improved mobility (as measured by the Rivermead Mobility Index) in those with higher levels of motor impairments (at baseline). These improvements were observed both at discharge and at 2 year follow-up compared to conventional gait training. However, these improvements were not observed in participants with fewer impairments (at baseline).
Economic evidence statements
No cost effectiveness evidence was identified.
13.9.2. Recommendations and link to evidence
| |
|---|---|
| Relative values of different outcomes | The outcomes of interest included in the review were walking speed and endurance, the Rivermead Mobility Index and two measures of dependence the Functional Independence Measure, and the Barthel Index. The GDG considered the results of the walking outcomes were of more relevance to the intervention. |
| Trade-off between clinical benefits and harms | Not applicable. The availability and usage of this equipment is currently extremely limited within the NHS. |
| Economic considerations | No cost effectiveness studies were identified for this question. The GDG noted that the main cost component for these interventions consists of the cost of acquiring and maintaining the machine, as well as the personnel costs (for example physiotherapist time) that may be required to aid the patient in using the electromechanical gait training. In addition, the GDG noted that there is very limited use of electromechanical gait training devices currently in the UK NHS. Considering the high initial outlay cost for electromechanical gait trainers and the limited evidence for their potential health benefits, the GDG concluded that there was insufficient evidence to conclude that electromechanical gain training represents a cost-effective use of NHS resources. |
| Quality of evidence | The GDG noted that many of the studies presented had severe to very serious limitations in terms of sample size and study design and there was insufficient evidence to support the use of electromechanical gait training. Many studies did not show a significant difference for the walking speed or capacity outcomes 114,118,204,233,260,281. In one well designed study by Pohl 209 there is evidence that in patients early after stroke (up to 2 months post stroke) with very poor mobility, who used the electro mechanical gait trainer showed an improvement in walking speed over usual practice which was maintained after 6 months. In addition, patients in the electromechanical gait trainer group showed a clinically significant improvement in Rivermead Mobility Index (post treatment and at 3, 6 months follow-up) and the Barthel Index (6 months follow-up). The recent publication of a study by Morone and colleagues (2012)179 with a 2 year follow-up showed that robotic gait training improved performance in the Rivermead Mobility and the Barthel index as well as in the Functional Ambulation categories. However, this effect was restricted to those with more severely impaired motor functioning at the outset. It was a small study with 12 participants in each arm and the confidence in effects was very variable ranging from moderate to very low. |
| Other considerations | The studies examined two different electromechanical gait trainers which vary in design and may feed into different physiological mechanisms. The Lokomat is a driven gait orthosis with electrical drives in knee and hip joints with 4 force transducers with 4 amplifiers that automates locomotion therapy on a treadmill. The orthosis is adaptable to subjects’ femur length. Reha-Stim is an electromechanical gait trainer with 2 foot plates whose movements simulated stance and swing phases. Step length and walking speed are continuously adjustable by a servo motor. Both use an element of body weight support. Future studies should address the underlying mechanisms of action. This type of intervention is used in some units but not commonly within the UK. There was agreement by the GDG that the evidence, based on two studies (Pohl et al., 2007 and Morone et al., 2012)209 )179 in favour of the Reha-Stim trainer was not strong enough to make a recommendation for use within the NHS, but that the intervention showed promise and an ‘only in research’ recommendation should be made. |
13.10. Ankle-foot orthoses
An Ankle-Foot Orthosis (AFO) is an appliance designed to support the foot and ankle. After stroke, it is typically prescribed for walking problems where the foot needs to be held up to prevent dragging (foot drop) and/or to give support to the ankle to prevent the leg from collapsing over the foot and ankle in stance. There are many different AFOs, but two common types are those which are rigid which offer greater stability and those that are hinged which offer help with dorsiflexion but less stability at the subtalar joint. AFOs may be custom made or ‘off the shelf’ and can be made from wide range of different materials. Assessment for use of an AFO should be carried out by an appropriately trained professional. An AFO is an adjunct to therapy and thus should be considered in the context of a comprehensive rehabilitation program with input from a multidisciplinary team.
13.10.1. Evidence review: In people after stroke what is the clinical and cost-effectiveness of Ankle-Foot orthoses of all types to improve walking function versus usual care?
| Clinical Methodological Introduction | |
|---|---|
| Population: | Adults and young people 16 or older who have had a stroke |
| Intervention: |
|
| Comparison: | Usual care |
| Outcomes: |
|
13.10.1.1. Clinical evidence
Searches were conducted for systematic reviews (of randomized controlled trials (RCTs) and cohort studies) and RCTs that compared the effectiveness of all types of ankle-foot orthoses with usual care to improve walking function for adults and young people 16 or older who have had a stroke. Only studies with a minimum sample size of 20 participants (10 in each arm) and including at least 50% of participants with stroke were selected. 5 RCTs (2 parallel and 3 cross-over RCTs) were identified.
Table 117
Summary of studies included in the clinical evidence review. For full details of the extraction please see Appendix H.
Comparison: Ankle-Foot Orthosis (AFO) of all types versus usual care
Table 118
Ankle-Foot Orthosis versus usual care-Clinical study characteristics and clinical summary of findings.
Narrative summary
The following study is summarised as a narrative because the results were not presented in numerical data that could be included in the GRADE table:
- Tyson, 2009 265 compared Ankle-Foot Orthosis (AFO) us with no AFO use in a crossover trial. Outcomes reported were functional mobility (measured with the Functional Ambulatory Category [FAC] scores) and walking impairments (walking speed and step length). The study design had serious limitations as there was no clear randomization [NB: The randomisation was the order of the 5 different trial conditions] and the outcome assessors were not blinded. Authors reported that functional mobility improved significantly with AFO use (P =.0001), while the walking impairments were unchanged (mean difference= 0; P [speed (m/s)] = 0.935, P [weak step length (m)] = 0.998. The study included severely impaired acute stroke patients who were not walking outside of Physiotherapy treatments.
13.10.1.2. Economic evidence
Literature review
No relevant economic evaluations comparing Ankle-Foot orthoses with usual care were identified.
Intervention costs
In the absence of cost-effectiveness analysis for this review question, the GDG considered the expected differences in resource use between the comparators and relevant UK NHS unit costs. Consideration of this alongside the clinical review of effectiveness evidence was used to inform their qualitative judgement about cost effectiveness.
An expert advisor to the GDG provided costs for AFOs similar to the ones in DeWit, 2004 study57 included in the clinical review (these were pre-fabricated, that is not custom-made):
- AFO with small posterior strut, £30.90 + VAT
- AFO with big posterior strut, £35.54 + VAT
- AFO with two crossed posterior struts, £51.05
Custom made AFOs would be made by a member of specialist multidisciplinary orthotics team and would incur higher costs. In addition, there would be personnel costs related to the time required to fit, trial and adjust the AFO to take into account the specific patient’s needs. The GDG has suggested that, in most cases, an orthotist would be performing this task. Adjustments may be made by either orthotists and experienced physiotherapists or occupational therapists (band 6 or 7), depending on the requirements (for example orthotists tend to make permanent and more complex adjustments). The estimated costs range from £45 to £59 per hour of client contacts.
Evidence statements
13.10.1.3. Clinical evidence statements
One study57 of 20 participants found that there was a statistically significant improvement in the group with Ankle-Foot Orthosis compared with the usual care group (post-treatment effect) in the following outcomes:
- Walking speed (cm/sec) (LOW CONFIDENCE IN EFFECT)
- Timed Up and Go (TUG) test (sec) (LOW CONFIDENCE IN EFFECT)
- stairs test (LOW CONFIDENCE IN EFFECT)
One study 266 of 25 participants found that the Ankle-Foot Orthosis group was associated with a statistically significant improvement compared with the usual care group at one month in the following outcomes:
- sound and weak stride length (MODERATE CONFIDENCE IN EFFECT)
- cadence (step frequency) (MODERATE CONFIDENCE IN EFFECT)
- walking speed (m/sec) (LOW CONFIDENCE IN EFFECT)
One study 266 of 25 participants found that there was no significant difference between the group with Ankle-Foot Orthosis and the group without Ankle-Foot Orthosis at one month in the following outcomes:
- sound and weak step length (VERY LOW CONFIDENCE IN EFFECT)
- step symmetry (VERY LOW CONFIDENCE IN EFFECT)
One study 21 of 30 participants showed no significant difference between the group with Ankle-Foot Orthosis and the usual care group at 12 weeks in the following outcomes:
- walking ability using Sickness Impact Profile scores: total score (VERY LOW CONFIDENCE IN EFFECT), ambulation (VERY LOW CONFIDENCE IN EFFECT) and physical dimension (VERY LOW CONFIDENCE IN EFFECT)
- walking speed: comfortable with shoes (LOW CONFIDENCE IN EFFECT) and maximal safe, with shoes (m/sec) (MODERATE CONFIDENCE IN EFFECT)
One study77 of 32 participants found no significant difference between the group with Ankle/Foot Orthoses and the usual care group (post-treatment effect) in the following outcomes:
- Timed Up and Go (TUG) test (sec) (LOW CONFIDENCE IN EFFECT)
- Timed Down Stairs (sec) (VERY LOW CONFIDENCE IN EFFECT)
- Timed Up Stairs (sec) (LOW CONFIDENCE IN EFFECT)
One study77 of 32 participants showed a statistical significant improvement in the Ankle foot orthoses group compared to the group that received usual care in walking speed (m/sec) (post-treatment effect) (MODERATE CONFIDENCE IN EFFECT)
13.10.1.4. Economic evidence statements
No cost-effectiveness evidence was identified.
13.10.2. Recommendations and link to evidence
| |
|---|---|
| Relative values of different outcomes | Effective AFOs should lead to improvements in walking speed and endurance. A number of factors are important in determining the long term effectiveness of an AFO, including comfort and the ability to put on the AFO easily. Some of the studies considered by the GDG may be regarded as efficacy trials (Tyson, 2001266) in that they examined immediate benefits and not long term outcomes. Attention needs to be paid to long-term functional outcomes within the home and community. |
| Trade-off between clinical benefits and harms | No harms were reported in the studies reviewed. The GDG agreed ankle foot orthoses (AFOs) should have a bio-mechanical rationale (to improve function), should be comfortable and well fitted to prevent pain and pressure sores. |
| Economic considerations | No cost effectiveness studies were identified for this question. The typical cost of AFOs was estimated to be between £30 and £51 depending on the type. Custom made AFOS would cost more. In addition there is some personnel time required to make adjustments for the patient. The GDG considered that in selected patients the additional cost of AFOs, both pre-made and custom made, had the potential to be offset by benefits to the patient in terms of improved function, and therefore improved quality of life. The GDG were aware that limited use is made of many prescribed orthoses with significant cost implications. |
| Quality of evidence | Three small studies demonstrated that the use of an AFO resulted in a statistically significant effect on velocity at post treatment (de Witt, 2004, Erel, 2011, Tyson, 2001 77.57,266). The study by Erel (2011) demonstrated a clinically significant improvement in walking speed in the ankle foot orthoses group. Confidence in the effects shown for this outcome ranged from very low to moderate due to limitations in study design and the mean difference not reaching the minimal important difference in two of the studies (de Witt 2004 and Tyson 200157,266). It was noted by the GDG that the effects shown in the De Wit study 57 may be underestimated because a flexible AFO was used. In clinical practice a rigid AFO would normally be used if the patient was very immobile. The mobility of the patients within this study was poor therefore for the patient the results may be considered highly clinically significant. In one study (by Beckerman 199621) some participants had already used ankle foot orthoses (AFO’s) which may have introduced a bias but it is unclear what direction the bias would effect. The population were stable and walked independently at a median velocity of .32 – .45 m/s, however, there was a large range of walking speeds in each group and no other treatment interventions. Therefore, though the study showed no effect, it is unclear how much difference would be seen with training. The GDG considered the Tyson 2009 study 265 to be one off tests, and although it demonstrated a statistically significant difference in favour of AFO it is unclear how these will translate into home and community settings. The GDG concluded that further research needs to be undertaken to evaluate the use of AFOs in the community setting. |
| Other considerations | The GDG considered that AFOs are used to support swing phase foot clearance to prevent tripping or falling and stance phase control to prevent the ankle of knee collapsing and therefore AFOs should be considered for patients who have these difficulties. The view of the group was that AFO’s improve walking speed in selected patients and the studies reviewed demonstrate this. The person would need to be able to put on the AFO themselves or have a family member/carer able to do this for them. The GDG agreed that all stroke units should have access to an orthotics service. AFOs should only be provided after assessment, fitting and trial by an appropriately trained and skilled multi-disciplinary team. Patients should be offered regular review and follow-up to ensure comfort, the appropriateness of the prescription to the individual’s day to day requirements and to ensure regular use. |
Footnotes
- r
Estimated based on data and methods from Personal Social Services Research Unit ‘Unit costs of health and social care’ report and Agenda for Change salary band 6 and 751 (typical salary band identified by clinical GDG members). Assumed that an orthotist is costed similar to a physiotherapist.
- s
Estimated based on data and methods from the Personal Social Services Research Unit ‘Unit costs of health and social care’ report and Agenda for Change salary bands 6 and 751 (typical salary band identified by clinical GDG members). Assumed that an orthotist is costed similar to a physiotherapist.
- Strength training
- Fitness Training
- Hand and arm therapies: orthoses for the upper limb
- Electrical stimulation: upper limb
- Constraint induced movement therapy
- Shoulder pain
- Repetitive task training
- Walking therapies: treadmill and treadmill with body weight support
- Electromechanical gait training
- Ankle-foot orthoses
- Movement - Stroke RehabilitationMovement - Stroke Rehabilitation
- Glossary - Stroke RehabilitationGlossary - Stroke Rehabilitation
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