13Movement

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.

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 review^{68,142,178,285} 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.

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 studies^136,195 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 studies^136,195 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.

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

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.

Clinical evidence statements

Economic evidence statement

No cost-effectiveness evidence was identified.

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.

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 contact^r.

Clinical evidence statements

Economic evidence statements

No cost effectiveness evidence was identified.

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.

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, 20–21^st 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.

Clinical evidence statements

Two studies^6,7 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 studies^6,7 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 studies^6,7 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 studies^{41;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 studies^{168; 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.

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.

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).

Clinical evidence statements

Four studies^{72,182,197,270} 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 studies^54,254,294 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 studies^54,254,294 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 studies^{153,197, 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 studies^{153,197,291,292} 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 studies^72,182 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.

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.

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.

Clinical evidence statements

Two studies^27,229 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 studies^27,229 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 studies^140,229 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:

• Action research arm test (upper limb training versus standard care)¹⁴⁰
• Motor assessment scale (hand) (upper limb training versus standard care)²⁷

Economic evidence statements

No cost effectiveness evidence was identified.

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.

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.

Clinical evidence statements

Two studies^{74, 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 studies^{74,143,147,208} 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 studies^74,190 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 studies^{272, 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 studies^{272, 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:

• Barthel index (treadmill with or without body weight support versus usual care)⁸⁶
• Rivermead gross function (treadmill with or without body weight support versus usual care)⁷⁴

Economic evidence statements

No cost-effectiveness evidence was identified.

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.

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, 20^th 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.

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.

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.

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 contact^s.

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.