Table 1.
Baseline demographics and clinical characteristics by randomisation group in the intention-to-treat population
| Robot-assisted training (n=257) | Enhanced upper limb therapy (n=259) | Usual care (n=254) | ||
|---|---|---|---|---|
| Gender | ||||
| Female | 101 (39%) | 100 (39%) | 101 (40%) | |
| Male | 156 (61%) | 159 (61%) | 153 (60%) | |
| Age at randomisation, years | 59·9 (13·5) | 59·4 (14·3) | 62·5 (12·5) | |
| Time from stroke to randomisation, days | 233 (102–549) | 258 (115–546) | 242 (107–549) | |
| Time from stroke to randomisation, months | ||||
| <3 | 57 (22%) | 46 (18%) | 58 (23%) | |
| 3–12 | 105 (41%) | 117 (45%) | 106 (42%) | |
| >12 | 95 (37%) | 96 (37%) | 90 (35%) | |
| Stroke type | ||||
| Cerebral infarction | 197 (77%) | 202 (78%) | 214 (84%) | |
| Primary intracerebral haemorrhage | 58 (23%) | 56 (22%) | 38 (15%) | |
| Subarachnoid haemorrhage | 2 (1%) | 1 (<1%) | 2 (1%) | |
| National Institute of Health Stroke Scale total score* | 5·6 (3·2) | 5·7 (3·2) | 5·8 (3·2) | |
| Arm affected by the stroke | ||||
| Right | 112 (44%) | 116 (45%) | 113 (44%) | |
| Left | 145 (56%) | 143 (55%) | 141 (56%) | |
| Handedness* | ||||
| Right | 221 (87%) | 223 (86%) | 228 (90%) | |
| Left | 34 (13%) | 35 (14%) | 25 (10%) | |
| Ambidextrous | 0 | 1 (<1%) | 1 (<1%) | |
| Action Research Arm Test† | ||||
| Mean (SD) | 8·5 (11·9) | 8·7 (11·9) | 8·1 (11·5) | |
| Median (IQR) | 3·0 (0·0–11·5) | 3·0 (0·0–13·0) | 3·0 (0·0–11·0) | |
| Score 0–7 | 178 (70%) | 175 (68%) | 173 (68%) | |
| Score 8–13 | 18 (7%) | 22 (8%) | 23 (9%) | |
| Score 14–19 | 13 (5%) | 9 (3%) | 13 (5%) | |
| Score 20–39 | 47 (18%) | 53 (20%) | 45 (18%) | |
| Fugl–Meyer assessment | ||||
| Motor score* | 18·0 (13·1) | 18·2 (14·1) | 18·2 (13·9) | |
| Total upper extremity score‡ | 68·9 (16·5) | 69·0 (17·9) | 68·9 (17·4) | |
| Barthel ADL Index* | 14·5 (3·8) | 14·3 (4·0) | 14·4 (3·9) | |
| Numerical pain scale§ | 2·9 (3·2) | 2·7 (3·0) | 2·6 (3·1) | |
Data are n (%), mean (SD), or median (IQR). ADL=activities of daily living.
*
Total number of patients was 255 in the robot-assisted training group.
†
Total number of patients was 256 in the robot-assisted training group.
‡
Total number of patients was 254 in the robot-assisted training group.
§
Total number of patients was 253 in the robot-assisted training group.