Researchers testing the ReWalk ReStore soft robotic exosuit for gait training in individuals undergoing post-stroke rehabilitation suggest it is safe and reliable during treadmill and overground walking under the supervision of physical therapists.

The results of the multi-center, single-arm trial was published open access recently in the Journal of NeuroEngineering and Rehabilitation.

The authors are the principal investigators of each of the five testing sites, per a media release from Kessler Foundation: Louis N. Awad, PT, DPT, PhD, of Spaulding Rehabilitation Hospital, Boston; Alberto Esquenazi, MD, of MossRehab Stroke and Neurological Disease Center, Elkins Park, Pa; Gerard E. Francisco, MD, of TIRR Memorial Hermann, Houston; Karen J. Nolan, PhD, of Kessler Foundation, West Orange, NJ; and lead investigator Arun Jayaramam, PT, PhD, of the Shirley Ryan AbilityLab, Chicago.

The ReStore exosuit, from ReWalk Robotics Ltd, Marlborough, Mass, is reportedly the first soft robotic exosuit cleared by the FDA for use in stroke survivors with mobility deficits. The device is indicated for individuals with hemiplegia undergoing stroke rehabilitation under the care of licensed physical therapists.

ReStore is designed to augment ankle plantarflexion and dorsiflexion, allowing a more normal gait pattern. Motors mounted on a waist belt transmit power through cables to attachment points on an insole and the patient’s calf. Sensors clipped to the patient’s shoes transmit data to a handheld smartphone controller used by a trained therapist to adjust levels of assistance and monitor and record key metrics of gait training, per the release.

Tested on Stroke Patients with Hemiparesis

The trial enrolled 44 participants with post-stroke hemiparesis who were able to walk unassisted for 5 feet. The protocol consisted of 5 days of 20-minute sessions of treadmill and overground training under the supervision of licensed physical therapists.

To assess the therapeutic potential for ReStore in rehabilitation, the researchers also explored the effects of the device on maximum walking speed, measuring participants’ walking speed in and out of the device using the 10-m walk test, before and after the five training visits. For safety purposes, some participants were allowed to use an AFO or cane during walking sessions.

The trial determined the safety, reliability, and feasibility of the device in this stroke population.

“We found that the ReStore provided targeted assistance for plantarflexion and dorsiflexion of the paretic ankle, improving the gait pattern,” explained Dr. Nolan, senior research scientist in the Center for Mobility and Rehabilitation Engineering Research at Kessler Foundation. “This is an important first step toward expanding options for rehabilitative care for the millions of individuals with mobility impairments caused by ischemic and hemorrhagic stroke.”

— Karen J. Nolan, PhD, senior research scientist in the Center for Mobility and Rehabilitation Engineering Research at Kessler Foundation

The trial’s exploratory data indicated positive effects of the training on the walking speed of participants during exosuit-assisted walking and unassisted walking (walking without the device). More than one third of participants achieved a significant increase in unassisted walking speed, indicating that further research is warranted, the release continues.

Nolan emphasizes that the trial was not designed to measure the device’s efficacy, adding that controlled trials are needed to determine the efficacy of ReStore for improving mobility outcomes of stroke rehabilitation.

[Source(s): Kessler Foundation, Science Daily]

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