MossRehab is the exclusive site in the U.S. for clinical trials of ReWalk™, the first commercially viable upright device that enables wheelchair users to stand, walk, and climb stairs.

In July, two individuals with spinal cord injuries demonstrated the use of ReWalk at MossRehab’s Gain and Motion Analysis Lab, moving independently from a wheelchair to standing and walking. Alysse Einbender, a 49-year-old woman paralyzed for the last five years, is the first subject to be part of U.S. clinical trials; and Radi Kaiuf, an experienced male user and paraplegic soldier from Israel, is an original patient from the trials held by Argo Medical Technologies, the Israeli company that developed the device.

MossRehab was selected as the site for U.S. clinical trials because of its international reputation for comprehensive clinical rehabilitation and research programs. Alberto Esquenazi, MD, director of the trial and Chief Medical Officer and Chairman of PM&R at MossRehab, was instrumental in the development of ReWalk.

The Device

Until now, there has not been a significant development for mobility-impaired people since the invention of the first molded plastic leg braces at MossRehab in the 1970s. ReWalk is a motorized quasi-robotic suit that consists of a lightweight wearable brace support suit, motorized joints, rechargeable batteries, an array of sensors and a computer-based patient control system. Working with users, rather than for them, the ReWalk suit weights just 35 pounds, and is worn around the legs and back and fits closely to the body on top of everyday clothing. The concurrent use of crutches stabilizes the upright patient, who is able to initiate and control movements through simple body language to control the legs.

The Proposed Benefit

ReWalk offers users more freedom than the traditional wheelchair. “There is a notion that being in a wheelchair is an acceptable paradigm for individuals who are paralyzed, and indeed wheelchairs have been the standard for decades,” notes Dr. Esquenazi. “But the ReWalk allows patients the choice of sitting, walking or standing. It offers them the freedom of interacting with the environment the way they choose.”

In an interview with the Associated Press, Alysse described her first time using ReWalk as “amazing…exhilarating [and] thrilling.” She said regaining the ability to stand upright felt “wonderful” and extolled ReWalk’s positive effect on her “self-esteem, life, enthusiasm and spirit.”

The device may also provide several key health benefits. By keeping patients upright on a daily basis and exercising their paralyzed limbs, ReWalk may alleviate many 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.

The Trial

The eight-week clinical trial will involve about twelve patients and will take one year to complete. The trial will be a single-center, open, non-comparative, non-randomized study of the safety and performance of the ReWalk. Subjects will be asked to put on the device and transfer from sit to stand, complete a 10-meter timed walk, and a six-minute walk test.

In Dr. Esquenazi’s Gait Lab, the subjects will be outfitted with dozens of specialized sensors that are able to detect movement within 2 millimeters. Using three-dimensional movement analysis software, Dr. Esquenazi will track the subtlest details of the subjects’ gait as they walk with ReWalk. The information he gathers will be used to calibrate ReWalk’s software to better interpret body language, and to develop a training manual that instructs users how to move smoothly with the device.

Results from Alysse’s trial have already led to adjustments in ReWalk’s software. Dr. Esquenazi noticed that she would occasionally move her trunk forward in an exaggerated manner to spur the device to move. ReWalk interpreted this as an intent to take two steps forward, which interrupted the flow of movement. To address this, Dr. Esquenazi added a delay to ReWalk’s software that prevents the device from taking more than one step per second.

Radi Kaiuf has been walking with the ReWalk for more than a year, and is the most experienced ReWalk user in the world. He underwent a full gait analysis at MossRehab’s Gait Lab, the results of which have formed the beginnings of the ReWalk training manual.

“Over the course of a year, Radi has acclimated his movement to the device. As he kicks right leg forward, his trunk leans back a bit. Then he moves his arms forward, and that triggers the next step,” Dr. Esquenazi said. “That synchronization is very difficult because it’s not natural. But he’s learned to do that, that’s what we need to teach our patients.”

If  the trials are successful and regulatory approvals are granted, Dr. Esquenazi believes the device could be on the market in 2011.