ReWalk Robotics Ltd. (“ReWalk” or “Company”), the leading global exoskeleton developer and manufacturer, announced that the Department of Veterans Affairs (“VA”) has publicly listed details of a national, multi-center study utilizing the Company’s Personal 6.0 Exoskeleton Systems.
The VA released full details of the study titled, “Exoskeleton Assisted-Walking in Persons With SCI: Impact on Quality of Life” on the clinical trials section of the National Institutes of Health (NIH) website. (www.clinicaltrials.gov Identifier: NCT02658656).
Several key components of the study outlined by the VA, include:
- Enrollment of 160 participants nationwide
- Eligibility criteria for study participants
- Study start date: October 2016
- Locations of six participating VA Medical Centers with Spinal Cord Injury Services in California, Florida, Massachusetts, Texas and Virginia
It was announced in January that the VA awarded a delivery order to Veterans Healthcare Supply Solutions (VHSS), the Service Disabled Veteran Owned Small Business (SDVOSB) authorized distributor of ReWalk Robotics, for six ReWalk exoskeleton systems to support this first-of-its-kind national study. ReWalk is the only FDA cleared exoskeleton technology for individuals with spinal cord injury. The Company has already shipped the order of six systems for the multi-center trial to the VA, and continues to work in coordination with the department as the study leads prepare for its launch this year.
“This VA clinical trial is groundbreaking in both its purpose and scope, and will undoubtedly provide a wealth of quality research data to the department’s already impressive research,” said ReWalk CEO Larry Jasinski. “ReWalk is glad to provide our technology to enable this critical national study.”
The Department of Veterans Affairs is the largest single healthcare provider to persons with Spinal Cord Injury (SCI) in the United States. This is the first study in the United States to examine the impact of exoskeleton use in a home or daily life setting. ReWalk has Class II FDA clearances for exoskeleton use in the rehabilitation and personal setting, with the latter intended for home and community use.
About ReWalk Personal 6.0
ReWalk Personal 6.0 is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury to stand upright and walk. The system provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system and motion sensors. The system allows independent, controlled walking while mimicking the natural gait patterns of the legs. The ReWalk device is the most studied exoskeleton in the industry. Studies have identified a number of health benefits including: improved bladder and bowel function, improved mental health, improved sleep, reduced fatigue, decreased body fat, decreased pain and improved posture and balance.