Exoskeletal-Assisted Walking in Veterans With Paralysis: A Randomized Clinical Trial

Abstract

Importance: Robotic exoskeletons leverage technology that assists people with spinal cord injury (SCI) to walk. The efficacy of home and community exoskeletal use has not been studied in a randomized clinical trial (RCT).

Objective: To examine whether use of a wheelchair plus an exoskeleton compared with use of only a wheelchair led to clinically meaningful net improvements in patient-reported outcomes for mental and physical health.

Design, setting, and participants: This RCT of veterans with SCI was conducted at 15 Veterans Affairs medical centers in the US from September 6, 2016, to September 27, 2021. Data analysis was performed from March 10, 2022, to June 20, 2024.

Interventions: Participants were randomized (1:1) to standard of care (SOC) wheelchair use or SOC plus at-will use of a US Food and Drug Administration (FDA)-cleared exoskeletal-assisted walking (EAW) device for 4 months in the home and community.

Main outcomes and measures: Two primary outcomes were studied: 4.0-point or greater improvement in the mental component summary score on the Veterans RAND 36-Item Health Survey (MCS/VR-36) and 10% improvement in the total T score of the Spinal Cord Injury-Quality of Life (SCI-QOL) physical and medical health domain and reported as the proportion who achieved clinically meaningful changes. The primary outcomes were measured at baseline, post randomization after advanced EAW training sessions, and at 2 months and 4 months (primary end point) in the intervention period. Device usage, reasons for not using, and adverse events were collected.

Results: A total of 161 veterans with SCI were randomized to the EAW (n = 78) or SOC (n = 83) group; 151 (94%) were male, the median age was 47 (IQR, 35-56) years, and median time since SCI was 7.3 (IQR, 0.5 to 46.5) years. The difference in proportion of successes between the EAW and SOC groups on the MCS/VR-36 (12 of 78 [15.4%] vs 14 of 83 [16.9%]; relative risk, 0.91; 95% CI, 0.45-1.85) and SCI-QOL physical and medical health domain (10 of 78 [12.8%] vs 11 of 83 [13.3%]; relative risk, 0.97; 95% CI, 0.44-2.15) was not statistically different. Device use was lower than expected (mean [SD] distance, 1.53 [0.02] miles per month), primarily due to the FDA-mandated companion being unavailable 43.9% of the time (177 of 403 instances). Two EAW-related foot fractures and 9 unrelated fractures (mostly during wheelchair transfers) were reported.

Conclusions and relevance: In this RCT of veterans with SCI, the lack of improved outcomes with EAW device use may have been related to the relatively low device usage. Solutions for companion requirements and user-friendly technological adaptations should be considered for improved personal use of these devices.

Trial registration: ClinicalTrials.gov Identifier: NCT02658656.

Figure.. Participant Flow Diagram

EAW indicates exoskeletal-assisted walking; ITT, intention to treat; and SOC, standard of care control group. Note that the EAW group is labeled “EAW and SOC” but is referred to in analyses as the EAW group. ^aThe major reasons for 1 or more screening failures were bone mineral density loss (n = 64), range of motion or spasticity (n = 39), medical contraindications (n = 31), failed EAW basic skills test (n = 32), anthropometric or weight limits (n = 27), fracture history (n = 21), level of spinal cord injury or neurologic status (n = 21), no companion available (n = 15), and other (n = 9). ^bThe COVID-19 early administrative withdrawals were participants who were actively enrolled in the study when the pandemic necessitated a study hold and were eventually terminated by the data monitoring committee due to an inability to restart the study. ^cThe 4 serious adverse events in the EAW group that resulted in early withdrawals were 2 fractures, including 1 femur fracture that occurred during transfer from wheelchair to toilet (not related) and 1 foot stress fracture (related) diagnosed as a probable preexisting stress fracture reoccurring during EAW; the other 2 serious adverse events were due to substance abuse and a medical issue, both of which were not study related. There were no adverse event–related early terminations in either group.