Table 2.
Assessments at baseline, 8 weeks, 6 months, and 12 months after randomisation
|
Baseline |
8 weeks |
6 months |
12 months |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Co-careldopa (n=308) | Placebo (n=285) | Co-careldopa (n=271) | Placebo (n=261) | Co-careldopa (n=242) | Placebo (n=250) | Co-careldopa (n=222) | Placebo (n=221) | ||
| Able to walk independently | 10 (3%) | 7 (3%) | 125/308 (41%) | 127/285 (45%) | 159/308 (52%) | 152/285 (53%) | 159/308 (52%) | 162/285 (57%) | |
| Odds ratio (95% CI); p value | .. | .. | .. | 0·78 (0·53–1·15); 0·212 | .. | .. | .. | .. | |
| Patient-reported RMI (as continuous) | 2·4 (2·2) | 2·5 (2·2) | 6·8 (4·2) | 7·0 (4·2) | 8·3 (4·6) | 8·1 (4·5) | 8·7 (4·7) | 8·5 (4·6) | |
| Adjusted mean difference (95% CI); p value | .. | .. | .. | −0·35 (−0·89 to 0·19); 0·198 | .. | 0·14 (−0·50 to 0·79); 0·662 | .. | 0·17 (−0·54 to 0·88); 0·637 | |
| NEADL* | 59·0 (11·0) | 58·6 (12·4) | 21·0 (17·7) | 20·0 (15·8) | 27·2 (18·2) | 27·3 (18·1) | 30·4 (19·4) | 29·8 (18·9) | |
| Adjusted mean difference (95% CI); p value | .. | .. | .. | 1·02 (−1·27 to 3·30); 0·382 | .. | 0·027 (−2·72 to 2·78); 0·985 | .. | 1·04 (−1·56, 3·64); 0·434 | |
| Barthel Index | 7·7 (3·8) | 7·8 (3·7) | 12·9 (5·1) | 13·2 (4·9) | 14·0 (5·1) | 14·4 (5·1) | 14·4 (5·4) | 14·6 (5·1) | |
| Adjusted mean difference (95% CI); p value | .. | .. | .. | −0·22 (−0·87 to 0·43); 0·511 | .. | −0·33 (−1·08 to 0·41); 0·378 | .. | −0·22 (−1·04 to 0·59); 0·591 | |
| ABILHAND, logits | 0·8 (3·9) | 0·3 (1·8) | 0·2 (2·3) | 0·4 (2·2) | 0·1 (2·4) | 0·3 (2·5) | 0·2 (2·6) | 0·4 (2·6) | |
| Adjusted mean difference (95% CI); p value | .. | .. | .. | −0·10 (−0·46 to 0·26); 0·585 | .. | −0·15 (−0·57 to 0·27); 0·478 | .. | −0·16 (−0·59 to 0·28); 0·479 | |
| GHQ-12 | 19·4 (6·7) | 19·3 (7·0) | 16·9 (7·2) | 16·4 (6·6) | 15·1 (7·0) | 16·3 (6·8) | 14·0 (6·8) | 14·4 (7·2) | |
| Adjusted mean difference (95% CI); p value | .. | .. | .. | 0·24 (−0·88 to 1·36); 0·677 | .. | −1·33 (−2·57 to 0·10); 0·035 | .. | −0·77 (−2·01 to 0·52); 0·241 | |
| No sign of psychological distress | 91 (30%) | 94 (33%) | 128 (42%) | 121 (43%) | 139 (45%) | 125 (44%) | 152 (49%) | 133 (47%) | |
| FAS | NA | NA | 25·1 (7·6) | 24·8 (7·4) | 25·9 (8·1) | 25·4 (7·6) | 24·9 (8·3) | 24·5 (8·2) | |
| mRS† | NA | NA | .. | .. | .. | .. | NA | NA | |
| 0 | .. | .. | 3 (1·0) | 1 (0·4) | 1 (0·3) | 2 (0·7) | .. | .. | |
| 1 | .. | .. | 15 (4·9) | 11 (3·9) | 29 (9·4) | 25 (8·8) | .. | .. | |
| 2 | .. | .. | 24 (7·8) | 30 (10·5) | 23 (7·5) | 30 (10·5) | .. | .. | |
| 3 | .. | .. | 101 (32·8) | 114 (40·0) | 123 (39·9) | 128 (44·9) | .. | .. | |
| 4 | .. | .. | 95 (30·8) | 79 (27·7) | 41 (13·3) | 47 (16·5) | .. | .. | |
| 5 | .. | .. | 34 (11·0) | 34 (11·9) | 27 (8·8) | 16 (5·6) | .. | .. | |
| 6 | .. | .. | 6 (1·9) | 1 (0·4) | 6 (1·9) | 4 (1·4) | .. | .. | |
| Odds ratio (95% CI); p value | .. | .. | .. | 0·87 (0·63 to 1·21); 0·404 | .. | 0·81 (0·57 to 1·14); 0·226 | .. | Not reported | |
| MoCA | 20·0 (6·6) | 20·5 (6·0) | 22·4 (6·3) | 22·9 (5·5) | 23·1 (6·2) | 23·6 (5·5) | 23·1 (5·9) | 23·5 (5·6) | |
| Adjusted mean difference (95% CI); p value | .. | .. | .. | −0·16 (−0·75 to 0·43); 0·592 | .. | −0·27 (−0·96 to 0·42); 0·445 | .. | −0·19 (−0·95 to 0·56); 0·613 | |
| Caregiver Burden Scale† | NA | NA | 43·0 (13·4) | 46·6 (13·9) | 44·6 (13·6) | 49·1 (14·7) | 44·6 (15·1) | 51·8 (15·3) | |
| Adjusted mean difference (95% CI); p value | .. | .. | .. | −4·55 (0·14 to 8·96); 0·043 | .. | −4·99 (0·173 to 9·811); 0·042 | .. | −7·17 (1·70 to 12·64); 0·011 | |
| Number of carer respondents | .. | .. | 74 | 72 | 62 | 65 | 50 | 107 | |
Data are mean (SD) or n (%), unless otherwise specified. The proportion of patients included for the secondary analyses are based on number of patients randomly assigned. RMI=Rivermead Mobility Index; a higher score indicates increasing ability to walk independently. NEADL=Nottingham Extended Activities of Daily Living Scale; a higher score indicates greater independence. ABILHAND=a Manual Ability Measure; raw scores are converted into a linear measure and expressed as logits; a higher number logit indicates greater patient's perceived ability. GHQ-12=General Health Questionnaire 12; a higher score indicates worse health. FAS=Fatigue Assessment Scale; a higher score indicates more severe fatigue. mRS=modified Rankin Scale; a higher score indicates greater levels of current functional independence; patients who die are given a score of 6. MoCA=Montreal Cognitive Assessment; score <26 indicates cognitive impairment. NA=not assessed. For Bartel index, a higher score indicates greater degree of functional independence.
Pre-stroke score.
Higher score indicated higher burden.