Exoskeletal assisted walking devices currently do not demonstrate clear benefits for patients with paralysis

1. In veterans with spinal cord injuries, exoskeletons showed no clear benefits (medical, physical or psychological) compared to standard wheelchair use

2. Exoskeleton technology is still not adopted readily with participants only using the devices an average of 86 minutes per week

Evidence Rating Level: 1 (Excellent)

Spinal cord injuries (SCI) often result in severe walking limitations which lead to various degrees of permanent disabilities. Walking strategies post-SCI have included leg bracing or functional electrical stimulation with crutches or a walker. These methods are highly energy intensive and have minimal long-term adoption. Exoskeletal devices are an energy-efficient solution to support walking in patients with SCI. They are made of motors at the hip and knees, supportive balance devices, and computer algorithms. The safety and efficacy of exoskeletal-assisted walking (EAW) has yet to be studied which was the reason for this randomized clinical trial. Participants were randomized to receive standard care (wheelchair use) or an FDA-cleared exoskeletal EAW device for 4 months. Satisfaction with either modality was measured using the 36-Item Health Survey (MCS/VR-36) and the Spinal Cord Injury-Quality of Life (SCI-QOL) physical and health domain. The primary outcome measurement for “improvement” in either score was a 4.0 increase in the MCS/VR-36 and 10% improvement in the total T score of the SCI-QOL. Within the 161 included participants, there was no significant difference in the proportion of participants who noted an improvement. The only significant difference seen between the two groups was the EAW group noted a significant reduction in sleep disturbance relative to the control group except at the final time point (4 months) where there was no significant difference. No other significant differences were seen in either the SCI Functional Index, SCI-QOL emotional health domain, nor the SCI-QOL social participation domain. The main reasons noted for not using the exoskeleton included companion unavailability (43.9%), illness (17.4%), being busy (14.4%), travel (9.2%), and weather (6.0%). Overall, no clinically meaningful changes in mental, physical, or medical well-being were seen. This could have been due to the low usage of the devices (86 minutes per week) which might not be enough to elicit meaningful changes for patients. To improve devices in the future, increasing usability (donning and doffing, self-balancing technology, etc.) could lead to increased adaptation of the technology.

Click to read the study in JAMA Network Open

Image: PD

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