MossRehab to host clinical trials of new ReStore-assistive walking device
MossRehab, the largest provider of inpatient and outpatient physical and cognitive rehabilitation in the Philadelphia region, is proud to announce that its Elkins Park location will serve as one of only five U.S. clinical trial sites for ReStore, a soft, exo-suit device that will assist patients with lower limb disabilities due to stroke to walk.
ReStore, a first-of-its-kind device unveiled in 2017, is the second product developed by ReWalk. (In 2009, MossRehab was the site of U.S. clinical trial for ReWalk, a motorized exoskeleton suit that enables patients with lower limb disabilities, including complete paralysis, to independently stand, walk, and–in some cases–climb stairs.) Designed to be a versatile, cost-effective gait therapy solution, the ReStore provides therapists with the ability to adjust and optimize a patient's treatment using real-time analytics. The ReStore promotes an improved gait with coordinated plantarflexion and dorsiflexion assistance to a patient's impaired foot and ankle. Power is transmitted from waist belt-mounted motors through cables to attachment points on the calf and an insole which is placed in the patient's shoe. Sensors clipped to the patient's shoes detect motion and inform timing of the assistance. Using a handheld smartphone controller, a trained therapist is able to adjust assistance level, monitor key metrics such as session progress and gait symmetry, and record standard gait training assessments. The company has announced pricing of under $20,000 for the device.
ReWalk anticipates commercializing the ReStore device for use by stroke patients in Europe and the United States in the first half of 2019, subject to the timing and receipt of CE mark and FDA clearance, respectively. Enrollment for the multi-center study is underway. The five research centers participating in the study with MossRehab include:
The Shirley Ryan AbilityLab in Chicago, Ill.;
Spaulding Rehabilitation Hospital in Boston, Mass., in partnership with Boston University College of Health and Rehabilitation Sciences: Sargent College;
TIRR Memorial Hermann in Houston, Texas; and K
essler Foundation in West Orange, N.J.
"We expect that the expansion of our clinical study to these renowned research organizations will bring the ReStore exo-suit closer to CE and FDA clearance,'' said ReWalk CEO Larry Jasinski. ''The ReStore will offer an immediate and cost-effective solution for the more than three million stroke patients in the U.S. with lower limb disabilities. We are thrilled to be partnering with the most prestigious institutions in the world to bring our product to market."