Robotic Exoskeleton Does Not Enhance QOL in Veterans With Spinal Cord Injury

Use of an exoskeleton does not enhance quality of life (QOL) in veterans with spinal cord injury (SCI), likely due to low device usage, according to study results published in JAMA Network Open.

Researchers conducted a parallel, 2-group, randomized controlled trial at 15 Veterans Affairs medical centers in the US between September 2016 and September 2021 to evaluate whether the use of an exoskeleton plus wheelchair use vs wheelchair use alone leads to more improved mental and physical health outcomes. Veterans aged 18 and older with spinal cord injury of more than 6 months who used a wheelchair for mobility were randomly assigned 1:1 to receive standard care (wheelchair use) plus voluntary use of a US Food and Drug Administration (FDA)-approved exoskeletal-assisted walking device or standard care alone for 4 months. Primary outcomes, which were measured at baseline, post-randomization, and at 2 and 4 months in the intervention period, included a 4.0-point and greater improvement in the mental component summary score on the Veterans RAND 36-Item Health Survey (MCS-VR-36) and 10% improvement in the summary T score of the Spinal Cord Injury-Quality of Life (SCI-QOL) physical and medical health domains. Generalized linear mixed models were used in statistical analysis.  

A total of 161 veterans were included in the analysis, of whom 83 (median age, 46; men, 95.2%; White, 65.1%; non-Hispanic/Latino, 75.9%) were randomly assigned to standard care and 78 (median age, 47; men, 92.3%; White, 70.5%; non-Hispanic/Latino, 84.6%) to the intervention. Overall, the median time since injury was 7.3 years.

No statistically significant differences were observed in the proportion of successes between the intervention vs standard care groups for the following outcomes:

• MCS/VR-36: 15.4% vs 16.9% (relative risk [RR], 0.91; 95% CI,0.45-1.85; P =.80);
• SCI-QOL physical and medical health domain: 12.8% vs 13.3% (RR, 0.97; 95% CI, 0.44-2.15; P =.93); and,
• TBFmass loss: 17.9% vs 19.3% (RR, 0.93; 95% CI, 0.49-1.78; P =.83).

Compared with the standard care group, the intervention group reported significant reduction in sleep disturbance at training and orientation (median change from baseline T score, -1.9 vs 1.3;  P =.01) and at 2 months (median change from baseline T score, -2.7 vs 1.8; P =.01), but not at 4 months.

Mean weekly use of the exoskeletal device was 86 minutes for 7.7 weeks. The primary barrier to device usage was companion unavailability (43.9%). The mean times of participation in typical activities (ie, household chores, stretching) was similar between the intervention (830 minutes per week) and standard care (937 minutes per week) groups.

In all, 11 fractures occurred, of which 9 were non-study-related and 2 were associated with exoskeleton device usage.

Study limitations include the high number of screen failures and withdrawals, as well as the low amount of device use.

“Solutions for companion requirements and user-friendly technological adaptations should be considered for improved personal use of [exoskeletal-assisted walking] devices,” the researchers concluded.