ReWalk Robotics Ltd announces the launch of its clinical study of the ReStore soft exo-suit system for the rehabilitation of individuals with lower limb disability due to a stroke.
Researchers from the Boston University College of Health and Rehabilitation Sciences: Sargent College are leading the study, which is intended to provide clinical data for an upcoming submission to the US Food and Drug Administration.
The first clinical study participant began using a ReStore suit recently at Spaulding Rehabilitation Hospital in Boston.
Up to 40 participants are being sought from rehabilitation hospitals across the United States, according to a media release from ReWalk Robotics Ltd.
“Launching the clinical study is a crucial step forward in the effort to offer the ReStore as a commercial product for the rehabilitation of stroke survivors worldwide,” says ReWalk CEO Larry Jasinski, in the release. “We are thrilled to continue our work with Spaulding—a renowned rehabilitation facility—and help patients access this cutting edge technology.”
The ReStore soft exo-suit system is a gait therapy solution powered with software and mechanics designed to transmit power to key points in the patient’s legs via cables connected to fabric-based designs that attach to the legs and feet.
“The ReWalk ReStore is an innovative device with potential to alter how we treat gait impairments after stroke,” states lead investigator Lou Awad, PT, DPT, PhD, per the release.
“We are excited to work with industry-leader ReWalk Robotics to kick off the first clinical trial of this next-generation rehabilitation technology,” adds, Awad, assistant professor, College of Health and Rehabilitation Sciences at Boston University, and Research Faculty Member at Spaulding’s Stroke Research & Recovery Institute.
[Source(s): ReWalk Robotics Ltd, PR Newswire]