| Outcomes | № of participants (studies) Follow-up | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects | Comments | |
|---|---|---|---|---|---|---|
| Risk with any other intervention | Risk difference with robot-assisted arm training | |||||
| Person/participant health related quality of life (SF-36 PCS, 0-100, higher values are better, change score) at end of intervention |
215 (2 RCTs) follow-up: mean 5 weeks |
⨁◯◯◯ | - | The mean person/participant health related quality of life at end of intervention was 1.37 |
MD 0.73 higher (0.81 lower to 2.27 higher) | MID = 2 (SF-36 established MID) |
| Person/participant health related quality of life (SF-36 MCS, 0-100, higher values are better, change score) at end of intervention |
215 (2 RCTs) follow-up: mean 5 weeks |
⨁◯◯◯ | - | The mean person/participant health related quality of life at end of intervention was 3.84 |
MD 1.14 lower (3.5 lower to 1.22 higher) | MID = 3 (SF-36 established MID) |
| Person/participant health related quality of life (EQ5D, −0.11-1, higher values are better, final values and change scores) at end of intervention |
716 (2 RCTs) follow-up: mean 4 weeks |
⨁◯◯◯ | - | The mean person/participant health related quality of life at end of intervention was 0.23 |
MD 0.01 higher (0.02 lower to 0.03 higher) | MID = 0.03 (EQ-5D established MID) |
| Person/participant health related quality of life (EQ5D, 0-100, higher values are better, change score) at ≥6 months |
194 (1 RCT) follow-up: 12 months |
⨁◯◯◯ | - | The mean person/participant health related quality of life at ≥6 months was 19.08 |
MD 4.67 lower (10.58 lower to 1.24 higher) | MID = 9.9 (0.5 x median baseline SD) |
| Person/participant health related quality of life (EQ5D, −0.11-1, higher values are better, final values) at ≥6 months |
625 (1 RCT) follow-up: 6 months |
⨁⨁◯◯ | - | The mean person/participant health related quality of life at ≥6 months was 0.5 |
MD 0.04 lower (0.09 lower to 0.01 higher) | MID = 0.03 (EQ-5D established MID) |
| Activities of daily living (Barthel index, functional independence measure, stroke impact scale, MAL, Frenchay arm test, ABILHAND [different scale ranges], higher values are better, change scores) at end of intervention |
1318 (25 RCTs) follow-up: mean 5 weeks |
⨁◯◯◯ | - | - |
SMD 0.41 SD higher (0.16 higher to 0.67 higher) | MID = 0.5 SD (SMD) |
| Activities of daily living (Barthel index, functional independence measure, Motor activity log [different scale ranges], higher values are better, final values) at end of intervention |
988 (11 RCTs) follow-up: mean 5 weeks |
⨁⨁⨁⨁ High | - | - |
SMD 0.14 SD higher (0.01 higher to 0.27 higher) | MID = 0.5 SD (SMD) |
| Activities of daily living (Barthel index, functional independence measure, motor activity log [different scale ranges], higher values are better, change scores) at ≥6 months |
469 (9 RCTs) follow-up: mean 6 months |
⨁⨁◯◯ | - | - |
SMD 0.28 SD higher (0.09 higher to 0.46 higher) | MID = 0.5 SD (SMD) |
| Activities of daily living (Barthel index, Functional Independence Measure [different scale ranges], higher values are better, final values) at ≥6 months |
670 (2 RCTs) follow-up: mean 4 months |
⨁⨁◯◯ Lowf | - | - |
SMD 0.02 SD higher (0.14 lower to 0.17 higher) | MID = 0.5 SD (SMD) |
| Arm function (FMA UE, Quick DASH, manual function test [different scale ranges], higher values are better, change scores) at end of intervention |
2167 (48 RCTs) follow-up: mean 5 weeks |
⨁⨁◯◯ | - | - |
SMD 0.34 SD higher (0.26 higher to 0.43 higher) | MID = 0.5 SD (SMD) |
| Arm function (FMA UE, Chedoke Arm and Hand Activity [different scale ranges], higher values are better, final values) at end of intervention |
1496 (24 RCTs) follow-up: mean 6 weeks |
⨁⨁◯◯ | - | - |
SMD 0.2 SD higher (0.09 higher to 0.31 higher) | MID = 0.5 SD (SMD) |
| Arm function (FMA UE, 0-66, higher values are better, change scores) at ≥6 months |
517 (11 RCTs) follow-up: mean 6 months |
⨁⨁⨁◯ Moderateh | - | The mean arm function at ≥6 months was 9.01 |
MD 1.08 higher (0.09 higher to 2.07 higher) | MID = 6.6 (Fugl-Meyer upper extremity = Difference by 10% of the total scale) |
| Arm function (FMA UE, Korean DASH [different scale ranges], higher values are better, final values) at ≥6 months |
930 (9 RCTs) follow-up: mean 4 months |
⨁◯◯◯ | - | - |
SMD 0.61 SD higher (0.18 higher to 1.03 higher) | MID = 0.5 SD (SMD) |
| Arm muscle strength (Motricity index, MRC, manual muscle test, MRC total motor power [different scale ranges], higher values are better, change scores) at end of intervention |
1019 (21 RCTs) follow-up: mean 5 weeks |
⨁◯◯◯ | - | - |
SMD 0.45 SD higher (0.17 higher to 0.72 higher) | MID = 0.5 SD (SMD) |
| Arm muscle strength (Motricity index, MRC [different scale ranges], higher values are better, final values) at end of intervention |
107 (3 RCTs) follow-up: mean 4 weeks |
⨁◯◯◯ | - | - |
SMD 0.89 SD higher (0.19 higher to 1.6 higher) | MID = 0.5 SD (SMD) |
| Arm muscle strength (grip strength [kg], higher values are better, change scores and final values) at end of intervention |
123 (5 RCTs) follow-up: mean 5 weeks |
⨁⨁⨁◯ Moderateb | - | The mean arm muscle strength at end of intervention was 3.48 |
MD 0.92 higher (0.39 lower to 2.22 higher) | MID = 1.83 (0.5 x median baseline SD) |
| Arm muscle strength (grip strength [Newton meter], higher values are better, change score and final value) at end of intervention |
114 (2 RCTs) follow-up: mean 6 weeks |
⨁⨁⨁⨁ High | - | The mean arm muscle strength at end of intervention was 6.8 |
MD 0.64 lower (4.18 lower to 2.91 higher) | MID = 4.3 (0.5 x median baseline SD) |
| Arm muscle strength (MRC total, MRC total motor power [different scale ranges], higher values are better, change scores) at ≥6 months |
164 (4 RCTs) follow-up: mean 5 months |
⨁◯◯◯ | - | - |
SMD 0.48 SD higher (0.57 lower to 1.53 higher) | MID = 0.5 SD (SMD) |
| Arm muscle strength (MRC total, MI [different scale ranges], higher values are better, final value) at ≥6 months |
84 (2 RCTs) follow-up: mean 2 months |
⨁◯◯◯ | - | - |
SMD 1.05 SD higher (0.59 higher to 1.51 higher) | MID = 0.5 SD (SMD) |
| Arm muscle strength (grip strength [kg], higher values are better, change score and final value) at ≥6 months |
71 (2 RCTs) follow-up: mean 6 months |
⨁⨁⨁◯ Moderateb | - | The mean arm muscle strength at ≥6 months was 5.17 |
MD 1.06 higher (1.02 lower to 3.14 higher) | MID = 1.83 (0.5 x median baseline SD) |
| Spasticity (MAS, MAS total [different scale ranges], lower values are better, change scores) at end of intervention |
761 (16 RCTs) follow-up: mean 5 weeks |
⨁⨁◯◯ | - | - |
SMD 0.23 SD lower (0.46 lower to 0.01 lower) | MID = 0.5 SD (SMD) |
| Spasticity (MAS, MAS total [different scale ranges], lower values are better, final values) at end of intervention |
356 (10 RCTs) follow-up: mean 5 weeks |
⨁⨁◯◯ Lowk | - | - |
SMD 0.21 SD lower (0.42 lower to 0) | MID = 0.5 SD (SMD) |
| Spasticity (MAS, MAS total [different scale ranges], lower values are better, change scores) at ≥6 months |
247 (7 RCTs) follow-up: mean 5 months |
⨁⨁◯◯ | - | - |
SMD 0.09 SD lower (0.34 lower to 0.17 higher) | MID = 0.5 SD (SMD) |
| Spasticity (MAS, MAS total [different scale ranges], lower values are better, final values) at ≥6 months |
153 (4 RCTs) follow-up: mean 3 months |
⨁◯◯◯ | - | - |
SMD 0.2 SD lower (0.52 lower to 0.12 higher) | MID = 0.5 SD (SMD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale total, 0-100, higher values are better, final values and change scores) at end of intervention |
284 (5 RCTs) follow-up: mean 7 weeks |
⨁⨁◯◯ | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 37.40 |
MD 5.31 higher (2.6 higher to 8.02 higher) | MID = 6.12 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - hand function domain [different scale ranges], higher values are better, change scores) at end of intervention |
382 (5 RCTs) follow-up: mean 3 weeks |
⨁◯◯◯ | - | - |
SMD 0.8 SD higher (0.31 lower to 1.91 higher) | MID = 0.5 SD (SMD) |
| Stroke-specific Patient-Reported Outcome Measures (SS-QOL, 49-245, higher values are better, final value) at end of intervention |
37 (1 RCT) follow-up: 4 weeks |
⨁◯◯◯ | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 140.8 |
MD 2.21 lower (23.36 lower to 18.94 higher) | MID = 14.1 (0.5 x median baseline SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - strength domain, 0-100, higher values are better, change score) at end of intervention |
117 (1 RCT) follow-up: 10 weeks |
⨁⨁⨁⨁ High | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 4.43 |
MD 3.45 higher (2.58 higher to 4.32 higher) | MID = 1.03 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - memory domain, 0-100, higher values are better, change score) at end of intervention |
117 (1 RCT) follow-up: 10 weeks |
⨁⨁⨁◯ Moderateb | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 1.4 |
MD 0.19 higher (0.52 lower to 0.9 higher) | MID = 0.84 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - emotion domain, 0-100, higher values are better, change score) at end of intervention |
117 (1 RCT) follow-up: 10 weeks |
⨁⨁⨁◯ Moderateb | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 0.78 |
MD 1.24 lower (1.7 lower to 0.78 lower) | MID = 0.91 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - communication domain, 0-100, higher values are better, change score) at end of intervention |
117 (1 RCT) follow-up: 10 weeks |
⨁⨁⨁◯ Moderateb | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 0.9 |
MD 0.32 lower (0.94 lower to 0.3 higher) | MID = 0.8 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - ADL domain, 0-100, higher values are better, change scores and final value) at end of intervention |
742 (3 RCTs) follow-up: mean 8 weeks |
⨁◯◯◯ | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 20.8 |
MD 0.12 higher (4.56 lower to 4.8 higher) | MID = 7.44 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - mobility domain, 0-100, higher values are better, change score and final value) at end of intervention |
725 (2 RCTs) follow-up: 12 weeks |
⨁⨁⨁⨁ High | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 32.2 |
MD 0.44 higher (3.91 lower to 4.79 higher) | MID = 6.5 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - social participation domain, 0-100, higher values are better, change score and final value) at end of intervention |
721 (2 RCT) follow-up: 12 weeks |
⨁⨁⨁◯ Moderateb | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 25.5 |
MD 2.81 higher (5.98 lower to 11.6 higher) | MID = 6.7 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - stroke recovery domain, 0-100, higher values are better, change score) at end of intervention |
117 (1 RCT) follow-up: 10 weeks |
⨁⨁⨁◯ Moderateb | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 7.43 |
MD 1.11 higher (0.21 higher to 2.01 higher) | MID = 1.18 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - physical domain, 0-100, higher values are better, change score) at end of intervention |
117 (1 RCT) follow-up: 10 weeks |
⨁⨁⨁⨁ High | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 2.28 |
MD 3.52 higher (2.99 higher to 4.05 higher) | MID = 0.68 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - hand function domain, 0-100, higher values are better, final value) at end of intervention |
608 (1 RCT) follow-up: mean 12 weeks |
⨁⨁⨁◯ Moderateo | - | The mean stroke-specific Patient-Reported Outcome Measures at end of intervention was 18.1 |
MD 2.6 lower (6.75 lower to 1.55 higher) | MID = 13.0 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale total, 0-100, higher values are better, change score and final value) at ≥6 months |
90 (2 RCTs) follow-up: mean 5 months |
⨁⨁◯◯ | - | The mean stroke-specific Patient-Reported Outcome Measures at ≥6 months was 25.1 |
MD 4.36 higher (1.64 lower to 10.36 higher) | MID = 12.0 (0.5 x median baseline SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - hand function domain, 0-100, higher values are better, final values and change scores) at ≥6 months |
819 (3 RCTs) follow-up: mean 7 months |
⨁⨁⨁◯ Moderaten | - | The mean stroke-specific Patient-Reported Outcome Measures at ≥6 months was 23.22 |
MD 0.27 lower (3.98 lower to 3.45 higher) | MID = 8.3 (0.5 x median baseline SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - ADL domain, higher values are better, change score and final value) at ≥6 months |
625 (2 RCTs) follow-up: mean 4 months |
⨁⨁⨁◯ Moderaten | - | The mean stroke-specific Patient-Reported Outcome Measures at ≥6 months was 29.87 |
MD 2.21 lower (5.71 lower to 1.28 higher) | MID = 8.2 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - mobility domain, higher values are better, final value) at ≥6 months |
608 (1 RCT) follow-up: 6 months |
⨁⨁⨁◯ Moderateo | - | The mean stroke-specific Patient-Reported Outcome Measures at ≥6 months was 63.4 |
MD 1.7 lower (5.77 lower to 2.37 higher) | MID = 11.9 (0.5 x median control group SD) |
| Stroke-specific Patient-Reported Outcome Measures (Stroke Impact Scale - social participation domain, higher values are better, final value) at ≥6 months |
604 (1 RCT) follow-up: 6 months |
⨁⨁⨁◯ Moderateo | - | The mean stroke-specific Patient-Reported Outcome Measures at ≥6 months was 50.0 |
MD 3 lower (7.23 lower to 1.23 higher) | MID = 12.1 (0.5 x median control group SD) |
| Withdrawal for any reason at end of intervention |
3954 (72 RCTs) follow-up: mean 6 weeks |
⨁◯◯◯ | RD 0.00 (−0.02 to 0.02) | 86 per 1,000 |
0 fewer per 1,000 (20 fewer to 20 more)s | Precision calculated through Optimal Information Size (OIS) due to zero events in some studies. OIS determined power for the sample size = 0.04 (0.8-0.9 = serious, <0.8 = very serious). |
| Withdrawal for any reason at ≥6 months |
1672 (21 RCTs) follow-up: mean 6 months |
⨁◯◯◯ | RD −0.02 (−0.04 to 0.01) | 84 per 1,000 |
20 more per 1,000 (40 fewer to 10 more)s | Precision calculated through Optimal Information Size (OIS) due to zero events in some studies. OIS determined power for the sample size = 0.13 (0.8-0.9 = serious, <0.8 = very serious). |
| Adverse events (cardiovascular events) at end of intervention |
770 (1 RCT) follow-up: 3 months |
⨁⨁◯◯ Lowb | RR 4.99 (0.97 to 25.55) | 4 per 1,000 |
16 more per 1,000 (0 fewer to 96 more) | MID (precision) = RR 0.80 – 1.25. |
| Adverse events (cardiovascular events) at ≥6 months |
770 (1 RCT) follow-up: 6 months |
⨁⨁◯◯ Lowb | RR 2.00 (0.28 to 14.09) | 4 per 1,000 |
4 more per 1,000 (3 fewer to 51 more) | MID (precision) = RR 0.80 – 1.25. |
| Adverse events (injuries and pain) at end of intervention |
555 (5 RCTs) follow-up: mean 7 weeks |
⨁◯◯◯ | RD 0.03 (−0.07 to 0.13) | 311 per 1,000 |
30 more per 1,000 (70 fewer to 130 more)s | Precision calculated through Optimal Information Size (OIS) due to zero events in some studies. OIS determined power for the sample size = 0.12 (0.8-0.9 = serious, <0.8 = very serious). |
| Adverse events (injuries and pain) at ≥6 months |
299 (3 RCTs) follow-up: mean 6 months |
⨁⨁⨁⨁ High | RD 0.00 (−0.02 to 0.02) | 0 per 1,000 |
0 fewer per 1,000 (20 fewer to 20 more)s | Sample size used to determine precision: 75-150 = serious imprecision, <75 = very serious imprecision. MID (clinical importance) = 50 per 1,000. |
| Adverse events (other reported adverse events) at end of intervention |
1736 (19 RCTs) follow-up: mean 6 weeks |
⨁◯◯◯ | RD 0.01 (−0.01 to 0.04) | 87 per 1,000 |
10 more per 1,000 (10 fewer to 40 more)s | Precision calculated through Optimal Information Size (OIS) due to zero events in some studies. OIS determined power for the sample size = 0.25 (0.8-0.9 = serious, <0.8 = very serious). |
| Adverse events (other reported adverse events) at ≥6 months |
1274 (10 RCTs) follow-up: mean 5 months |
⨁◯◯◯ | RD 0.00 (−0.03 to 0.04) | 113 per 1,000 |
0 fewer per 1,000 (30 fewer to 40 more)s | Precision calculated through Optimal Information Size (OIS) due to zero events in some studies. OIS determined power for the sample size = 0.52 (0.8-0.9 = serious, <0.8 = very serious). |
Downgraded by 2 increments as the majority of the evidence was of very high risk of bias (due to bias arising from the randomisation process, bias due to deviation from the intended intervention, bias due to missing outcome data and bias in measurement of the outcome)
Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs
Downgraded by 2 increments as the majority of the evidence was of very high risk of bias (due to bias in the randomisation process, bias due to missing outcome data and bias in measurement of the reported result)
Downgraded by 2 increments as the majority of the evidence was of very high risk of bias (due to bias in measurement of the outcome and bias in selection of the reported result)
Downgraded by 1 increment as the majority of the evidence was of high risk of bias (due to bias in measurement of the outcome)
Downgraded by 1 or 2 increments because heterogeneity, unexplained by subgroup analysis
Downgraded by 1 increment as the majority of the evidence was of high risk of bias (due to a mixture of bias arising from the randomisation process, bias due to deviations from the intended intervention, bias due to missing outcome data, bias in measurement of the outcome and bias in selection of the reported result)
Downgraded by 1 increment as the majority of the evidence was of high risk of bias (due to a mixture of bias arising from the randomisation process, bias due to deviations from the intended intervention and bias due to missing outcome data)
Downgraded by 1 increment as the majority of the evidence was of high risk of bias (due to a mixture of bias arising from the randomisation process, bias due to deviations from the intended intervention, bias due to missing outcome data and bias in measurement of the outcome)
Downgraded by 1 increments due to outcome indirectness (as the majority of evidence was reported at a follow up of less than 6 months)
Downgraded by 2 increments as the majority of the evidence was of very high risk of bias (due to bias arising from the randomisation process, bias due to deviation from the intended intervention, bias due to missing outcome data, bias in measurement of the outcome and bias in selection of the reported result)
Downgraded by 1 increment as the majority of the evidence was of high risk of bias (due to a mixture of bias arising from the randomisation process, bias due to deviations from the intended intervention, bias due to missing outcome data and bias in measurement of the outcome)
Downgraded by 2 increments as the majority of the evidence was of very high risk of bias (due to bias due to deviation from the intended intervention and bias due to missing outcome data)
Downgraded by 1 increment as the majority of the evidence was of high risk of bias (due to a mixture of bias arising from the randomisation process and bias in measurement of the outcome)
Downgraded by 1 increment as the majority of the evidence was of high risk of bias (due to bias in measurement of the outcome)
Downgraded by 1 increment as the majority of the evidence was of high risk of bias (due to a mixture of bias arising from the randomisation process, bias due to deviations from the intended intervention and bias due to missing outcome data)
Downgraded for heterogeneity due to conflicting number of events in different studies (zero events in one or more studies)
Downgraded by 1 to 2 increments for imprecision due to zero events and small sample size
Absolute effect calculated by risk difference due to zero events in at least one arm of one study
From: Evidence reviews for robot-assisted arm training
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