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 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.
How does ReWalk work?
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 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 ReWalk?
By keeping patients upright on a daily basis and exercising their paralyzed limbs, 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 ReWalk?
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 ReWalk.
Is the device approved for use in the United States?
Not yet. The 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 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.
What are the details of the trial?
Dr. Esquenazi, MD, chairman and chief medical officer of MossRehab continues his work validating the safety and efficacy of ReWalk. To date, Dr. Esquenazi and his team have screened 14 subjects and completed training in 10 subjects. Every subject was able to independently transfer from sitting to standing, and was able to walk using the ReWalk with crutches. The velocity of walking ranged from 0.3 to 0.6 m/s and patients were able to walk distances common in most households. Patients were able to stand safely and sit independently. Over the course of the study, Dr. Esquenazi notes a marked improvement in his subjects’ physical endurance. There have been no significant adverse effects, and all patients were satisfied and are willing to use the system long-term when it is commercially available in the United States.
The patient criteria are as follows:
- Men and women
- Ages between 18 and 55
- Height between 1.60 and 1.90 meters (5’3”-6’2”)
- Weight less than 100 kg (220 lbs.)
- Patients are paraplegic due to spinal cord injury at or below T2
- Injuries occurred at least six months prior to the trial
- Patients are regular users of an orthotic walking device or standing frame
- Patients do not have a history of other cardiac, respiratory or metabolic medical problems, severe spasticity, uncontrolled clonus, or history of traumatic brain injury or psychiatric disorders.
Prior to the trial, patients must undergo radiographic assessments of their spines and leg bones, skin examinations, and DEXA scans to assess bone density.
When will 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.
How much will the ReWalk cost? Will insurances cover this cost?
At this time we are unable to project the retail cost of 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?
ReWalk News Coverage
FOX TV_Glee - A Very Glee Christmas episode_Minute 38 - December 7, 2010
Glee Clip from YouTube - December 7, 2010
ABC's Good Morning America visits MossRehab
New York Daily News - February 4, 2010
Forbes Break Out - August 2009
6ABC video - Update to Hope for SCI Patients - August 26, 2009
6ABC video - Hope for Spinal Cord Injury Patients - June 30, 2009
CBS3 video - Device Changes Life of Area Paraplegic - June 30, 2009
MossRehab Exclusive Site for U.S. Clinical Trials - June 30, 2009