Table 2.
Primary outcome of Amended Motor Club Assessment (AMCA) scores at 36 weeks: primary modified intention-to-treat (mITT) analysis and Complier Average Causal Effect (CACE) sensitivity analyses
|
AMCA score for standing frame group (n=71) |
AMCA score for usual care group (n=69) |
AMCA score for compliers |
AMCA score for non-compliers plus usual care group |
Fully adjusted analysis, mean difference (95% CI)* | Analysis adjusted for baseline alone, mean difference (95% CI) | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Week 36 | Baseline | Week 36 | Baseline | Week 36 | Baseline | Week 36 | ||||
| mITT analysis | 26·1 (13·9; 3·0–59·0; n=71)† | 29·3 (17·2; 1·0–68·0; n=61)† | 30·2 (14·6; 6·0–66·0; n=69)† | 28·2 (17·0; 0·0–68·0; n=61)† | .. | .. | .. | .. | 4·7 (1·9–7·5); p=0·0014 | 4·6 (1·6–7·6); p=0·0030 | |
| CACE analyses | |||||||||||
| Best 16 weeks | .. | .. | .. | .. | 26·2 (13·7; 3·0–56·0; n=49)† | 29·9 (16·0; 6·0–65·0; n=46)† | 29·1 (14·6; 6·0–66·0; n=91)† | 28·4 (17·5; 1·0–68·0; n=76)† | 6·1 (2·5–9·8); p=0·00094 | 6·1 (2·2–9·9); p=0·0020 | |
| Worst 16 weeks | .. | .. | .. | .. | 28·2 (13·4; 8·0–56·0; n=36)† | 31·6 (16·4; 8·0–65·0; n=35)† | 28·1 (14·7; 3·0–66·0; n=104)† | 27·9 (17·1; 1·0–68·0; n=87)† | 7·9 (3·1–12·8); p=0·0013 | 7·9 (2·8–13·0); p=0·0025 | |
| Weeks 5–20 | .. | .. | .. | .. | 26·7 (14·0; 3·0–56·0; n=46)† | 30·5 (15·9; 6·0–65·0; n=43)† | 28·8 (14·5; 6·0–66·0; n=94)† | 28·1 (17·5; 1·0–68·0; n=79)† | 6·5 (2·6–10·4); p=0·0010 | 6·5 (2·3–10·6); p=0·0022 | |
| Best 32 weeks | .. | .. | .. | .. | 26·6 (14·0; 3·0–56·0; n=46)† | 32·4 (16·6; 6·0–65·0; n=43)† | 32·4 (16·6; 6·0–65·0; n=43)† | 28·0 (14·5; 6·0–66·0; n=94)† | 6·5 (2·7–10·4); p=0·00077 | 6·5 (2·4–10·5); p=0·0016 | |
| Worst 32 weeks | .. | .. | .. | .. | 28·4 (13·9; 8·0–56·0; n=36)† | 32·4 (16·6; 6·0–65·0; n=35)† | 28·0 (14·5; 3·0–66·0; n=104)† | 27·5 (16·9; 1·0–68·0; n=87)† | 7·9 (3·1–12·7); p=0·0013 | 7·8 (2·8–12·9); p=0·0025 | |
| Weeks 5–36 | .. | .. | .. | .. | 27·3 (13·8; 3·0–56·0; n=42)† | 31·9 (15·7; 6·0–65·0; n=41)† | 28·5 (14·6; 4·0–66·0; n=98)† | 27·5 (17·4; 1·0–68·0; n=81)† | 6·8 (2·8–10·8); p=0·00078 | 6·8 (2·6–11·0); p=0·0016 | |
Data are mean (SD; range), unless otherwise specified. Mean differences in both analyses are between the standing and usual care group.
*
Adjusted for baseline AMCA Score, region and Expanded Disability Status Scale category.
†
n is the total number of participants who provided data at that timepoint.