Table 2. Results of the Primary and Major Secondary Outcome Measures by Time Point and Group (Primary Analysis, All Participants)^a.

Outcome	EAW group (n = 78)	SOC group (n = 83)	RR (95% CI)	P value
Mental component summary of the Veterans RAND 36-Item Health Surveyb
Baseline score, median (IQR)	65.4 (58.4 to 67.3) (n = 78)	63.4 (53.9 to 67.2) (n = 82)		.34
Training and orientation	66.5 (59.8 to 68.6) (n = 54)	62.4 (55.8 to 66.1) (n = 68)		.01
2 Months (intervention)	65.3 (58.0 to 68.3) (n = 48)	63.7 (49.6 to 67.6) (n = 60)		.17
4 Months (intervention)	65.4 (60.2 to 69.1) (n = 45)	62.1 (48.1 to 67.8) (n = 57)		.15
Change from baseline by time point
Training and orientation	1.3 (−2.2 to 6.1) (n = 54)	−1.2 (−4.7 to 3.4) (n = 67)		.08
2 Months (intervention)	1.1 (−2.4 to 4.3) (n = 48)	0.3 (−4.3 to 3.8) (n = 59)		.36
4 Months (intervention)	0.0 (−4.8 to 4.3) (n = 45)	0.8 (−6.7 to 3.9) (n = 56)		.88
Primary outcome (≥4-point improvement), No. (%)
Success	12 (15.4)	14 (16.9)	0.91 (0.45 to 1.85)	.80
Failure	66 (84.6)	69 (83.1)
SCI-QOL physical medical health domainc
Baseline score, median (IQR)	152 (137 to 167) (n = 78)	149 (135 to 170) (n = 83)		.86
Training and orientation	146 (137 to 162) (n = 54)	153 (134 to 173) (n = 67)		.61
2 Months (intervention)	147 (130 to 161) (n = 47)	145 (134 to 169) (n = 58)		.41
4 Months (intervention)	146 (133 to 163) (n = 43)	147 (129 to 170) (N = 57)		.58
Change from baseline by time point
Training and orientation	−3.2 (−13.4 to 5.9) (n = 54)	0.0 (−11.6 to 1.9) (n = 67)		.19
2 Months (intervention)	−1.3 (−12.4 to 3.0) [47]	−1.4 (−12.9 to 9.4) (n = 58)		.26
4 Months (intervention)	−4.1 (−17.2 to 3.3) (n = 43)	−1.0 (−1.5 to 12.0) (n = 57)		.16
Primary outcome (10% improvement in summary T score), No. (%)
Success	10 (12.8)	11 (13.3)	0.97 (0.44 to 2.15)	.94
Failure	68 (87.2)	72 (86.7)
Total body fat massd
Baseline, mean (SD), kg	27.3 (9.1) (n = 78)	27.0 (8.6) (n = 83)		.86
Training and orientation	28.4 (9.5) (n = 54)	27.4 (8.7) (n = 65)		.57
2 Months (intervention)	28.5 (9.6) (n = 47)	27.0 (8.5) (n = 57)		.41
4 Months (intervention)	28.5 (9.7) (n = 45)	26.5 (7.7) (n = 55)		.26
Change from baseline by time point, median (IQR)
Training and orientation	0.4 (−0.9 to 1.2) (n = 54)	0.2 (−0.8 to 1.3) (n = 65)		.84
2 Months (intervention)	0.6 (−1.1 to 2.2) (n = 47)	0.0 (−1.3 to 1.2) (n = 57)		.45
4 Months (intervention)	0.4 (−1.7 to 1.9) (n = 45)	−0.2 (−1.2 to 1.9) (n = 55)		.79
Major secondary outcome (≥1.0 kg loss), No. (%)
Success	14 (17.9)	16 (19.3)	0.93 (0.49 to 1.78)	.83
Failure	64 (82.1)	67 (80.7)

Abbreviations: EAW, exoskeletal-assisted walking; RR, relative risk; SCI-QOL, Spinal Cord Injury–Quality of Life; SOC, standard of care.

^a The 2 primary and the major secondary outcome measurements were based on the percentage of individuals in each group who achieved the described specific criteria (success) for each variable at 4 months after randomization. Continuous data with normal distribution are presented as mean (SD) using unpaired, 2-tailed t tests, and nonnormally distributed data are presented as median (IQR) using Wilcoxon tests.

^b Mental component summary of the Veterans RAND 36-Item Health Survey for vitality, social functioning, role-emotional, and mental health.^22,23

^c Summary T score for the SCI-QOL physical, medical, and health domain for 4 of the item banks: bladder management difficulties, bladder complications, bowel management difficulties, and pain interference.²⁴

^d Total body fat mass was determined by dual energy x-ray absorptiometry scanning.^25,26