Table 2.
Comparison of ARAT success between groups
| Robot-assisted training | Enhanced upper limb therapy | Usual care |
Robot-assisted training vs usual care |
Enhanced upper limb therapy vs usual care |
Robot-assisted training vs enhanced upper limb therapy |
||||
|---|---|---|---|---|---|---|---|---|---|
| Unadjusted odds ratio (98·3% CI) | Adjusted* odds ratio (98·3% CI) | Unadjusted odds ratio (98·3% CI) | Adjusted* odds ratio (98·3% CI) | Unadjusted odds ratio (98·3% CI) | Adjusted* odds ratio (98·3% CI) | ||||
| Primary outcome†(3 months) | |||||||||
| ITT | 103/232 (44%) | 118/234 (50%) | 85/203 (42%) | 1·11 (0·70–1·76) | 1·17 (0·70–1·96)‡ | 1·41 (0·89–2·24) | 1·51 (0·90–2·51)† | 0·78 (0·50–1·22) | 0·78 (0·48–1·27)† |
| Sensitivity analysis 1 | 89/197 (45%) | 94/187 (50%) | 66/157 (42%) | 1·14 (0·68–1·91) | 1·11 (0·63–1·95) | 1·39 (0·83–2·35) | 1·39 (0·79–2·44) | 0·82 (0·50–1·33) | 0·80 (0·47–1·37) |
| Sensitivity analysis 2 | 71/148 (48%) | 81/145 (56%) | 56/116 (48%) | 0·99 (0·55–1·79) | 1·12 (0·56–2·22) | 1·36 (0·75–2·47) | 1·56 (0·78–3·12) | 0·73 (0·42–1·28) | 0·72 (0·38–1·38) |
| Per-protocol analysis | 97/222 (44%) | 112/219 (51%) | NA | NA | NA | NA | NA | 0·74 (0·47–1·17) | 0·73 (0·43–1·22) |
| Secondary outcome†(6 months) | |||||||||
| ITT | 103/221 (47%) | 118/218 (54%) | 81/185 (44%) | 1·12 (0·69–1·81) | 1·24 (0·72–2·14) | 1·52 (0·94–2·45) | 1·63 (0·94–2·82) | 0·74 (0·47–1·17) | 0·76 (0·45–1·28) |
| Sensitivity analysis 1 | 91/200 (46%) | 110/203 (54%) | 71/163 (44%) | 1·08 (0·65–1·80) | 1·26 (0·71–2·23) | 1·53 (0·92–2·54) | 1·64 (0·93–2·90) | 0·71 (0·44–1·14) | 0·77 (0·45–1·31) |
| Sensitivity analysis 2 | 72/139 (52%) | 84/136 (62%) | 55/109 (50%) | 1·06 (0·57–1·95) | 1·31 (0·62–2·76) | 1·59 (0·85–2·96) | 1·92 (0·90–4·11) | 0·67 (0·37–1·20) | 0·68 (0·34–1·38) |
| Per-protocol analysis | 97/213 (46%) | 113/206 (55%) | NA | NA | NA | NA | NA | 0·69 (0·43–1·10) | 0·70 (0·41–1·20) |
Data are n/N (%) unless otherwise stated. ARAT=Action Research Arm Test. ITT=intention to treat. NA=not applicable because a formal comparison to usual care would be biased. Per-protocol analysis=participants included if they attended at least 20 sessions of therapy. Sensitivity analysis 1=ITT patients who were assessed within the specified window of 3 months ± 14 days for 3-month assessment or 6 months ± 28 days for the 6-month assessment. Sensitivity analysis 2=ITT patients excluding those with a baseline ARAT score of zero.
*
Adjusted for the variables of time since stroke, baseline ARAT score, and centre.
†
Simple imputation was used in the calculation of the ARAT total score.
‡
Primary outcome analysis.