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)

Table 3 Crossover analyses of the primary and other endpoints

Group A (N = 13) vs Group B (N = 11)	Treatment effect Mean(95% CI)	p value	Carryover effect Mean(95% CI)	p value	Period effect Mean(95% CI)	p value
Outcome measures
2MWT %	10.066 (0.667, 19.464)	0.037	5.511 (− 5.982, 17.005)	0.331	− 9.371 (− 18.769, 0.027)	0.051
10MWT speed	9.140 (− 0.357, 18.636)	0.059	2.520 (− 6.919, 11.959)	0.585	− 4.623 (− 14.120, 4.873)	0.324
10MWT cadence	7.100 (2.609, 11.591)	0.003	1.373 (− 4.658, 7.405)	0.641	− 1.760 (− 6.251, 2.731)	0.425
10MWT step length	1.238 (− 4.811, 7.288)	0.675	1.369 (3.878, − 6.616)	0.594	− 2.529 (− 8.578, 3.520)	0.395
Visual gait assessment total score	1.167 (− 0.056, 2.389)	0.060	0.75 (− 0.221,1.721)	0.123	0.015 (− 1.056, 1.389)	0.780
Total MMT score*	3.04 SD (5.57)	0.039	1.81 SD (3.24)	0.148	− 2.68 SD (5.57)	0.063
Barthel index score*	0.4 SD (1.6)	0.909	0.0 SD (2.4)	0.675	− 0.9 SD (1.6)	0.119
PRO total score (Post–pre)	− 5.294 (− 70.379, 59.792)	0.868	− 7.3217 (− 84.858, 70.2150)	0.847	− 23.4755 (− 88.561, 41.610)	0.462
PRO total score (Post−then)	4.032 (− 52.215, 60.278)	0.883	23.101 (− 68.065, 114.267)	0.604	− 31.877 (− 88.124, 24.369)	0.252
Response shift total score (Pre−then)	9.325 (− 42.263, 60.913)	0.711	30.423 (− 36.371, 97.217)	0.355	− 8.402 (− 59.990, 43.186)	0.739

p value was calculated using a two-sample t test or Mann–Whitney U test*; CI, confidence interval; SD, standard deviation; 2MWT, two-minute walk test; 10MWT, ten-metre walk test; MMT, manual muscle test; PRO, patient-reported outcome

ISSN: 1750-1172