A clinical protocol specific to ReWalk Robotics’ ReWalk Personal System has been established by the U.S. Department of Veterans Affairs (VA). The protocol includes definitions, veteran evaluation components, indications and contraindications, clinician documentation requirements, and recommendations for informed consent, as well as the specific criteria for providing the device to a veteran for use in rehabilitation, at home, and in community settings for both temporary lease and definitive purchase.
This is currently the only robotic exoskeleton that is cleared by the U.S. Food and Drug Administration (FDA) for issuance to an individual with a spinal cord injury (SCI) when specific and extensive criteria are met. The VA stated that a clinical protocol, instead of a definitive national policy, was documented in recognition that updates will be necessary as clinical knowledge and experience with the ReWalk and other exoskeletons evolve.
Veterans interested in being evaluated for robotic exoskeleton technologies will be referred to one of the Veterans Health Administration’s 24 regional SCI Centers. When preliminary criteria are met following a comprehensive initial evaluation, the veteran will be referred to a VA SCI ReWalk Training Center. As of December 17, 2015, there are 11 VA SCI ReWalk Training Centers. Additionally, as of December 2015, robotic exoskeleton technologies are owned by 14 VA medical centers (VAMCs), 12 of which are regional SCI Centers; both the ReWalk and Ekso Bionics’ Ekso GT are utilized in VAMCs in a clinical setting.
“The research support and effort to provide eligible veterans with paralysis an exoskeleton for home use is a historic move on the part of the VA because it represents a paradigm shift in the approach to rehabilitation for persons with paralysis,” Ann Spungen, PhD, said according to a quote by the AP news service. Spungen led VA research on the system; she is the director and associate director of the VA’s Rehabilitation Research & Development National Center of Excellence for the Medical Consequences of Spinal Cord Injury.
