Table 3.
Secondary outcomes in the intention-to-treat population
|
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 |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | n | Mean (SD) | Unadjusted mean difference (98·3% CI) | Adjusted* mean difference (98·3% CI) | Unadjusted mean difference (98·3% CI) | Adjusted* mean difference (98·3% CI) | Unadjusted mean difference (98·3% CI) | Adjusted* mean difference (98·3% CI) | |
| ARAT score† | ||||||||||||
| 3 months | 232 | 15·5 (19·1) | 234 | 17·3 (20·1) | 203 | 14·2 (19·6) | 1·24 (−3·30 to 5·69) | 1·37 (−1·05 to 3·79) | 3·03 (−1·59 to 7·54) | 2·54 (0·02 to 5·14) | −1·80 (−6·15 to 2·58) | −1·18 (−3·62 to 1·21) |
| 6 months | 221 | 16·5 (19·7) | 218 | 17·2 (19·9) | 185 | 16·4 (21·3) | 0·14 (−4·80 to 5·01) | 0·97 (−1·85 to 3·70) | 0·78 (−4·27 to 5·64) | 0·26 (−2·60 to 2·98) | −0·64 (−5·15 to 3·91) | 0·70 (−1·82 to 3·30) |
| FMA total score† | ||||||||||||
| 3 months | 232 | 76·6 (22·1) | 234 | 77·8 (22·8) | 202 | 74·2 (23·6) | 2·37 (−2·90 to 7·64) | 3·12 (−0·03 to 6·50) | 3·62 (−1·76 to 8·93) | 3·66 (0·52 to 6·84) | −1·25 (−6·16 to 3·71) | −0·54 (−3·41 to 2·63) |
| 6 months | 221 | 78·2 (22·8) | 218 | 79·4 (24·1) | 186 | 77·9 (23·2) | 0·33 (−5·20 to 5·77) | 1·62 (−1·84 to 5·17) | 1·46 (−4·27 to 7·03) | 1·84 (−1·77 to 5·29) | −1·13 (−6·46 to 4·24) | −0·22 (−3·63 to 3·42) |
| FMA: motor subscale† | ||||||||||||
| 3 months | 232 | 26·2 (17·7) | 234 | 27·1 (18·3) | 202 | 24·2 (18·4) | 2·03 (−2·16 to 6·17) | 2·79 (0·66 to 5·01) | 2·91 (−1·34 to 7·10) | 2·96 (0·86 to 5·02) | −0·87 (−4·84 to 3·13) | −0·17 (−2·18 to 1·95) |
| 6 months | 221 | 27·2 (18·4) | 217 | 28·2 (19·3) | 186 | 26·3 (18·9) | 0·90 (−3·59 to 5·33) | 2·54 (0·07 to 5·06) | 1·90 (−2·69 to 6·40) | 2·40 (−0·16 to 4·84) | −0·99 (−5·32 to 3·29) | 0·14 (−2·32 to 2·72) |
| Barthel ADL Index† | ||||||||||||
| 3 months | 233 | 15·5 (3·4) | 236 | 15·9 (3·4) | 207 | 15·3 (3·8) | 0·18 (−0·65 to 1·00) | 0·18 (−0·37 to 0·75) | 0·65 (−0·17 to 1·47) | 0·70 (0·16 to 1·25) | −0·47 (−1·22 to 0·28) | −0·51 (−1·02 to −0·01) |
| 6 months | 223 | 15·6 (3·4) | 222 | 16·0 (3·5) | 190 | 15·3 (3·7) | 0·28 (−0·55 to 1·12) | 0·45 (−0·12 to 1·05) | 0·64 (−0·21 to 1·50) | 0·88 (0·29 to 1·48) | −0·36 (−1·15 to 0·42) | −0·43 (−0·98 to 0·13) |
| SIS: hand function† | ||||||||||||
| 3 months | 219 | 15·5 (24·4) | 223 | 21·4 (27·9) | 193 | 14·3 (22·9) | 1·26 (−4·25 to 6·83) | 2·56 (−2·62 to 7·93) | 7·16 (1·11 to 13·08) | 7·93 (2·24 to 13·51) | −5·90 (−11·85 to 0·12) | −5·37 (−10·86 to 0·18) |
| 6 months | 213 | 15·7 (25·2) | 216 | 18·4 (26·2) | 179 | 14·8 (23·5) | 0·94 (−4·99 to 6·78) | 1·94 (−3·56 to 7·47) | 3·60 (−2·42 to 9·52) | 3·91 (−1·76 to 9·59) | −2·65 (−8·58 to 3·35) | −1·96 (−7·40 to 3·59) |
| SIS: mobility† | ||||||||||||
| 3 months | 219 | 61·6 (25·1) | 223 | 66·4 (23·2) | 192 | 61·0 (24·6) | 0·64 (−5·27 to 6·45) | 1·31 (−4·30 to 6·87) | 5·44 (−0·13 to 11·11) | 5·81 (0·45 to 11·20) | −4·80 (−10·35 to 0·71) | −4·50 (−9·87 to 0·88) |
| 6 months | 213 | 61·7 (24·8) | 216 | 63·9 (23·7) | 180 | 62·9 (23·8) | −1·19 (−7·05 to 4·73) | −0·46 (−6·00 to 5·09) | 1·07 (−4·65 to 6·79) | 1·44 (−4·06 to 6·83) | −2·26 (−7·91 to 3·32) | −1·90 (−7·28 to 3·48) |
| SIS: ADL† | ||||||||||||
| 3 months | 220 | 50·8 (22·5) | 223 | 55·9 (19·8) | 194 | 50·8 (21·1) | 0·004 (−5·11 to 5·20) | 0·75 (−4·16 to 5·77) | 5·13 (0·30 to 9·91) | 5·55 (0·87 to 10·21) | −5·13 (−9·97 to −0·27) | −4·81 (−9·48 to −0·12) |
| 6 months | 212 | 50·4 (22·3) | 216 | 52·5 (22·3) | 179 | 51·9 (21·3) | −1·42 (−6·68 to 3·88) | −0·56 (−5·60 to 4·52) | 0·59 (−4·65 to 5·85) | 1·10 (−3·90 to 6·13) | −2·01 (−7·18 to 3·14) | −1·66 (−6·66 to 3·31) |
| SIS: social participation† | ||||||||||||
| 3 months | 217 | 47·7 (24·7) | 221 | 51·7 (23·0) | 193 | 47·1 (23·7) | 0·62 (−5·14 to 6·32) | 0·54 (−5·18 to 6·19) | 4·64 (−0·90 to 10·11) | 4·70 (−0·75 to 10·13) | −4·02 (−9·48 to 1·47) | −4·16 (−9·57 to 1·34) |
| 6 months | 210 | 47·0 (25·9) | 216 | 50·2 (24·4) | 179 | 49·2 (23·8) | −2·24 (−8·30 to 3·87) | −2·21 (−8·23 to 3·87) | 1·02 (−4·84 to 6·86) | 1·22 (−4·66 to 7·03) | −3·26 (−9·07 to 2·62) | −3·43 (−9·16 to 2·43) |
| Upper limb pain (numerical rating scale) | ||||||||||||
| 3 months | 232 | 2·5 (3·2) | 236 | 2·2 (2·9) | 206 | 2·7 (3·2) | −0·19 (−0·93 to 0·54) | −0·24 (−0·90 to 0·42) | −0·55 (−1·26 to 0·15) | −0·55 (−1·20 to 0·09) | 0·36 (−0·32 to 1·03) | 0·31 (−0·31 to 0·93) |
| 6 months | 223 | 2·5 (3·2) | 221 | 2·5 (3·2) | 190 | 2·0 (2·9) | 0·52 (−0·22 to 1·24) | 0·37 (−0·32 to 1·06) | 0·48 (−0·26 to 1·20) | 0·36 (−0·34 to 1·06) | 0·04 (−0·69 to 0·77) | 0·01 (−0·68 to 0·70) |
Data are n or mean (SD). ARAT=Action Research Arm Test. FMA=Fugl–Meyer Assessment. ADL=activities of daily living. SIS=Stroke Impact Scale.
*
Adjusted for the variables of time since stroke, baseline scale score (not available for SIS), and centre.
†
Simple imputation was used in the calculation of the score.