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Related Experiment Video

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

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Robotic exoskeletons did not show improved mental or physical health outcomes for veterans with spinal cord injury (SCI) in a randomized clinical trial. Low device usage, often due to companion app issues, may explain the results.

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Area of Science:

  • Rehabilitation Engineering
  • Assistive Technology
  • Clinical Trials

Background:

  • Robotic exoskeletons offer potential mobility assistance for individuals with spinal cord injury (SCI).
  • The effectiveness of home and community use of exoskeletons in SCI populations has not been rigorously evaluated through randomized clinical trials (RCTs).

Purpose of the Study:

  • To investigate if using a wheelchair with an exoskeleton, compared to wheelchair use alone, leads to meaningful improvements in patient-reported mental and physical health outcomes.
  • To assess the efficacy of exoskeletal-assisted walking (EAW) in a real-world setting for veterans with SCI.

Main Methods:

  • A randomized clinical trial involving 161 veterans with SCI across 15 US Department of Veterans Affairs medical centers.
  • Participants were assigned to either standard of care (SOC) wheelchair use or SOC with at-will use of an FDA-cleared EAW device for 4 months.
  • Primary outcomes included clinically meaningful improvements in mental component summary scores (MCS/VR-36) and SCI-QOL physical and medical health domain scores.

Main Results:

  • No statistically significant differences were observed between the EAW and SOC groups for the primary mental or physical health outcomes.
  • Device usage was lower than anticipated, with the companion app unavailable 43.9% of the time, impacting consistent use.
  • Two EAW-related foot fractures and nine unrelated fractures were reported; most unrelated fractures occurred during wheelchair transfers.

Conclusions:

  • The study did not find improved patient-reported outcomes with EAW device use in veterans with SCI, potentially due to low device utilization.
  • Addressing companion technology availability and enhancing user-friendliness are crucial for improving the personal utility of EAW devices.
  • Further research should focus on optimizing device accessibility and user experience to realize the full benefits of exoskeletal technology for SCI rehabilitation.