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Table 3 Crossover analyses of the primary and other endpoints

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)

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
  1. 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