Background
Atypical
walking in the months and years after stroke constrain community
reintegration and reduce mobility, health, and quality of life. The
ReWalk ReStore™ is a soft robotic exosuit designed to assist the
propulsion and ground clearance subtasks of post-stroke walking by
actively assisting paretic ankle plantarflexion and dorsiflexion.
Previous proof-of-concept evaluations of the technology demonstrated
improved gait mechanics and energetics and faster and farther walking in
users with post-stroke hemiparesis. We sought to determine the safety,
reliability, and feasibility of using the ReStore™ during post-stroke
rehabilitation.
Methods
A
multi-site clinical trial (NCT03499210) was conducted in preparation
for an application to the United States Food and Drug Administration
(FDA). The study included 44 users with post-stroke hemiparesis who
completed up to 5 days of training with the ReStore™ on the treadmill
and over ground. In addition to primary and secondary endpoints of
safety and device reliability across all training activities, an
exploratory evaluation of the effect of multiple exposures to using the
device on users’ maximum walking speeds with and without the device was
conducted prior to and following the five training visits.
Results
All
44 study participants completed safety and reliability evaluations.
Thirty-six study participants completed all five training days. No
device-related falls or serious adverse events were reported. A low rate
of device malfunctions was reported by clinician-operators. Regardless
of their reliance on ancillary assistive devices, after only 5 days of
walking practice with the device, study participants increased both
their device-assisted (Δ: 0.10 ± 0.03 m/s) and
unassisted (Δ:
0.07 ± 0.03 m/s) maximum walking speeds (P’s < 0.05).
Conclusions
When
used under the direction of a licensed physical therapist, the ReStore™
soft exosuit is safe and reliable for use during post-stroke gait
rehabilitation to provide targeted assistance of both paretic ankle
plantarflexion and dorsiflexion during treadmill and overground walking.
Trial registration
NCT03499210. Prospectively registered on March 28, 2018.
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