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Table 4 Changes in primary and secondary endpoints over the course of the study periods

From: Cybernic treatment with wearable cyborg Hybrid Assistive Limb (HAL) improves ambulatory function in patients with slowly progressive rare neuromuscular diseases: a multicentre, randomised, controlled crossover trial for efficacy and safety (NCY-3001)

  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)       
  1. *p value was calculated using a one-sample t test or Wilcoxon signed-rank test
  2. **p value was calculated using a two-sample t test or ††Mann–Whitney U test
  3. SD, standard deviation; CI, Confidence Interval; 2MWT, two-minute walk test; 10MWT, ten-metre walk test; MMT, manual muscle test; PRO, patient-reported outcome