| ReWalk - Frequently Asked Questions |
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What is ReWalk? MossRehab is the exclusive U.S. clinical trial site for a new assistive device called ReWalk. ReWalk is a motorized exoskeleton suit that enables patients with lower limb disabilities, including complete paralysis, to independently engage in ambulatory activities, including standing, walking and in some cases climbing stairs. ReWalk consists of a lightweight wearable brace support suit, motorized joints, rechargeable batteries, an array of sensors and a computer-based control system. Worn around the legs, chest and back, it fits closely to the body on top of everyday clothing. Patient stability during ambulation is provided by concurrent use of crutches.
The ReWalk contains intricate motion sensors that measure the patient’s upper body movements and shifts in gravity. These signals are processed by an onboard computer system that initiates and maintains walking in the desired direction at the appropriate speed. Which patients can use the ReWalk? ReWalk can be used by patients with spinal cord and brain injuries, stroke, multiple sclerosis, cerebral palsy and other diseases that result in walking impairments. What are the proposed benefits of the ReWalk? By keeping patients upright on a daily basis and exercising their paralyzed limbs, the ReWalk may alleviate many of the health problems associated with long-term immobility, including osteoporosis, pressure sores, and problems with the urinary, respiratory, cardiovascular and digestive systems. ReWalk is also an alternative to other walking assistive and standing devices. Likewise, patients who use ReWalk can reduce their dependence on powered wheelchairs and the oversized vehicles required to transport them. Who developed the ReWalk? The ReWalk was designed by Argo Medical Technologies, a medical device company located in Haifa, Israel. Visit their web site to view a video of a paraplegic patient regaining mobility with the ReWalk. Is the device approved for use in the United States? Not yet. An exclusive U.S. clinical trial of the device is currently being held at MossRehab. A preliminary trial has been conducted in Israel to demonstrate safety. Availability of the device for clinical use is dependent upon FDA approval. What are the details of the trial? The trial is a single-center, open, non-comparative, non-randomized study of the safety and performance of the ReWalk. The overall objectives and endpoints of this clinical trial are to establish the safety and performance of the ReWalk suit and demonstrate initial efficacy and user satisfaction. Under the direction of principal investigator Alberto Esquenazi, MD, twelve subjects with paraplegia due to spinal cord injury at or below the thoracic level will use the ReWalk over a three-month period. The primary outcome measures will be the completion of independent walking using the ReWalk and crutches, and the ability to independently stand from a seated position using the device. The patient criteria are as follows:
Prior to the trial, patients will undergo radiographic assessments of their spines and leg bones, skin examinations, and DEXA scans to assess bone density. What is the goal of the trial? We hope that positive outcomes data will garner FDA approval for clinical use of the device in the United States. When will the ReWalk be available for purchase? Due to the complex nature of the clinical trials process, we are unable to estimate when the device will be available for purchase. However, Argo Medical Technologies expects the ReWalk to be commercially available in late 2010. How much will the ReWalk cost? Will insurances cover this cost? At this time we are unable to project the retail cost of the ReWalk. We do not yet know if U.S. insurance carriers will cover the device. Which other technologies does MossRehab utilize in the course of treatment? Over the years, MossRehab has eagerly adopted a variety of innovative robotic technologies, including the Lokomat™, SMART Balance Master®, and Reo Therapy™ robotic system. For a partial list of some of the technologies our patients use on a daily basis, please visit the Therapeutic Modalities & Tools section of the MossRehab.com web site. To receive more information on the ReWalk as it becomes available, please email Nancy Dawes ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it .) |