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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