Table 5.
As-treated and per-protocol analyses of primary and secondary walking outcomes
| Variable | As-treated | Per-protocol | ||||
|---|---|---|---|---|---|---|
| Exoskeleton n = 14 | Usual Care n = 22 | p-value | Exoskeleton n = 14 | Usual Care n = 17 | p-value | |
| FAC, median (IQR) | ||||||
| Baseline | 0 (0–1) | 0 (0–1) | 0 (0–1) | 0 (0–1) | ||
| Discharge | 4 (3–4) | 3 (2–4) | 4 (3–4) | 3 (3–4) | ||
| Change from baseline | 3 (2–4) | 2.5 (2–3) | 0.12a | 3 (2–4) | 3 (2–3) | 0.40a |
| 6-month follow-up | 4.5 (4–5) | 4 (2.25–4) | 4.5 (4–5) | 4 (3–5) | ||
| Change from baseline | 4 (3–4.75) | 3 (2–4) | 0.09a | 4 (3–4.75) | 3 (3–4) | 0.40a |
| Gait speed, m/s, mean (SD) | ||||||
| Discharge | 0.47 (0.3) | 0.30 (0.3) | 0.15a | 0.47 (0.3) | 0.35 (0.3) | 0.31b |
| 6-month follow-up | 0.67 (0.5) | 0.35 (0.3) | 0.04a | 0.67 (0.5) | 0.42 (0.3) | 0.10b |
| 6MWT, m, mean (SD) | ||||||
| Discharge | 145.8 (110.2) | 80.1 (85.0) | 0.08a | 145.8 (110.2) | 93.0 (84.0) | 0.14b |
| 6-month follow-up | 211.2 (147.2) | 103.0 (93.5) | 0.03a | 211.2 (147.2) | 123.4 (90.1) | 0.05b |
| Days to unassisted walkingc | 24.1 (9.7) | 36.7 (16.1) | 0.03b | 24.1 (9.7) | 35.3 (15.7) | 0.05b |
6MWT 6-minute walk test, FAC Functional Ambulation Category, IQR interquartile range, SD standard deviation
aAnalyzed using Mann–Whitney U test
bAnalyzed using independent t-test
cExoskeleton n = 11, Usual Care (as-treated) n = 15, Usual Care (per-protocol) n = 14
Bold indicates a significant p-value < 0.05