Table 4.
Changes in primary and secondary endpoints over the course of the study periods
| First treatment period (V13–V4) | First + second treatment periods (V23–V4) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment 1 in Group A (Control) N = 13 |
p value* | Treatment 2 in Group B (HAL) N = 11 |
p value* | Treatment 2 vs. Treatment 1 N = 11,13 |
p value** | Group A (Control + HAL) N = 13 |
p value* | Group B (HAL + Control) N = 11 |
p value* | Group A vs. Group B N = 13,11 |
p value** | |
| Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | |||||||
| 2MWT Distance | 9.297 (− 0.153, 18.746) | 0.053 | 24.874 (11.439, 38.309) | 0.021 | 15.577 (0.494, 30.660) | 0.044 | 16.808 (4.694, 28.922) | 0.011 | 41.944 (17.266, 66.622) | 0.004 | − 25.14 (− 49.650, − 0.621) | 0.045 |
| 10MWT Speed | 7.706 (− 1.327, 16.740) | 0.088 | 19.366 (8.870, 29.863) | 0.002 | 11.660 (− 1.304, 24.624) | 0.075 | 17.321 (4.776, 29.867) | 0.011 | 30.951 (18.934, 42.969) | 0.0002 | − 13.630 (− 30.204, 2.943) | 0.102 |
| 10MWT Cadence | 2.802 (− 2.928, 8.533) | 0.308 | 11.276 (6.221, 16.331) | 0.0006 | 8.474 (1.127, 15.820) | 0.026 | 10.603 (0.461, 20.746) | 0.042 | 13.270 (7.619, 18.921) | 0.0004 | − 2.661(− 14.249, 8.914) | 0.638 |
| 10MWT Step length | 4.555 (− 0.717, 9.828) | 0.084 | 7.163 (0.228, 14.098) | 0.044 | 2.607 (− 5.451, 10.666) | 0.509 | 6.176 (0.335, 12.016) | 0.040 | 15.581 (7.102, 24.059) | 0.002 | − 9.405(− 18.84, 0.031) | 0.051 |
| Visual gait assessment total score | − 0.462 SD(3.126) | n/a | 1.000 SD(1.483) | n/a | 1.462 (− 0.676, 3.599) | 0.17 | ||||||
| MMT total score | 0.23 (− 1.46, 1.92) | 0.844† | 1.77 (0.34, 3.20) | 0.016† | 1.54(− 0.60,3.68) | 0.150†† | 0.77 (− 0.31, 1.85) | 0.191† | 1.91 (0.40, 3.42) | 0.023† | − 1.14 (− 2.85, 0.57) | 0.180†† |
| Barthel index score | 1.2 (− 0.2, 2.5) | 0.250† | 1.4 (− 0.8, 3.5) | 0.500† | 0.2 (− 2.1,2.5) | 0.902†† | 1.5 (− 0.4, 3.4) | 0.250† | 1.4 (− 0.8, 3.5) | 0.500† | 0.2 (− 2.5, 2.9) | 0.838†† |
| PRO total score (Post–Pre) | 101.6 (4.2, 199.0) | 0.042 | 89.0 (19.5, 158.5) | 0.017 | − 12.6 (− 129.9, 104.6) | 0.825 | 128.5 (30.6, 226.5) | 0.014 | 121.9 (46.9, 196.9) | 0.005 | 6.6 (− 113.5, 126.8) | 0.9099 |
| PRO total score (Post-Then) | 80.2 (3.1, 157.4) | 0.042 | 107.4 (30.2, 184.5) | 0.011 | 27.1 (− 76.5, 130.8) | 0.593 | ||||||
| All periods (V24–V4) | ||||||
|---|---|---|---|---|---|---|
| Group A (Control + HAL) N = 12 |
p value* | Group B (HAL + Control) N = 11 |
p value* | Group A vs. Group B N = 12,11 |
p value** | |
| Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | ||||
| 2MWT Distance | 12.534 (− 3.505, 28.573) | 0.113 | 35.594 (11.276, 59.911) | 0.0086 | − 23.059 (− 49.924, 3.805) | 0.089 |
| 10MWT Speed | 18.180 (− 0.853, 37.212) | 0.060 | 27.429 (13.160, 41.699) | 0.0016 | − 9.250 (− 31.967, 13.467) | 0.407 |
| 10MWT Cadence | 9.190 (− 2.3335, 20.714) | 0.107 | 11.04 (6.9550, 15.125) | 0.0001 | − 1.850 (− 13.813, 10.113) | 0.751 |
| 10MWT Step length | 7.486 (− 0.235, 15.206) | 0.056 | 14.680 (3.060, 26.301) | 0.0183 | − 7.195 (− 20.065, 5.675) | 0.258 |
| Visual gait assessment total score | ||||||
| MMT total score | 0.46 (− 1.29, 2.22) | 0.605† | 2.05 (0.36, 3.73) | 0.027† | − 1.58 (− 3.91, 0.74) | 0.171†† |
| Barthel index score | 1.5 (− 0.4, 3.4) | 0.250† | 0.9 (− 0.4, 2.3) | 0.500† | 0.6 (− 1.7, 2.9) | 0.743†† |
| PRO total score (Post–pre) | ||||||
| PRO total score (Post–then) | ||||||
*p value was calculated using a one-sample t test or †Wilcoxon signed-rank test
**p value was calculated using a two-sample t test or ††Mann–Whitney U test
SD, standard deviation; CI, Confidence Interval; 2MWT, two-minute walk test; 10MWT, ten-metre walk test; MMT, manual muscle test; PRO, patient-reported outcome