By Andy Zou
For the approximately 200,000 Americans with a spinal cord injury suffering from partial or complete paralysis, there is something new to look forward to — a technology that will enable them to walk again, free from the constraints of a wheelchair or a traditional walker usually supported by a suspension harness.
Meet the ReWalk — a robotic battery-powered exoskeleton that mechanically powers movement of the hips and knees, enabling paraplegics to stand and walk freely again, invented by Israeli scientist and CEO of Argo Medical Technologies Inc. Dr. Amit Goffer.
On June 26, 2014, it was approved by the U.S. Food and Drug Administration for public use and became the first motorized device enabling Americans with lower-body paralysis to gain mobility. Prior to FDA approval, the exoskeleton could only be worn in the hospital.
The FDA cleared the ReWalk after extensively reviewing testing done on hardware, battery systems and safety systems, as well as reviewing clinical studies done on 30 participants and observational data gathered from 16 other patients who were asked to walk various distances on various terrains and surfaces in their homes or communities.
In clearing the ReWalk, the FDA also mandated post-market clinical studies by Argo Medical Technologies to collect data on various incidents related to the use of the ReWalk and to assess the adequacy of ReWalk’s training program.
ReWalk has received excellent reviews not only from its users, but also from manufacturers and company leaders alike who have heralded this cutting-edge technology as a breakthrough that will transform the lives of paralyzed individuals and enable them to stand up to disability. “The person walks the system, the system does not walk them,” remarked Goffer.
CEO of ReWalk Robotics Larry Jasinski commented that “individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and capitalize on the physiological and psychological benefits we have observed in clinical trials.”
U.S. Marine Derek Herera, a paraplegic and one of the first Americans to own a ReWalk, has described this device “as a milestone for people in the same situation who will now have access to this technology, to experience walking again, and all of the health benefits that come with ReWalking.”
The positive effects being evaluated include reductions in body fat; improvements in cardio-respiratory function, as well as bowel and bladder function; improvements in sitting posture; and decreased pain. Side effects include pressure sores, bruising or abrasions.
ReWalk has a battery capacity that lasts eight hours on a single charge, enabling paraplegic Americans to fulfill their daytime walking needs conveniently without having to worry about suddenly losing balance should the Rewalk lose power.
ReWalk consists of several components. On-board computers and motion and tilt sensors detect body weight shifts and, instinctively, the ReWalk takes its first step following the users’ commands.
A watch on the wrist enables users to tell the ReWalk when to sit, stand, walk forward or climb steps. Motor pods and metal braces help support the legs and lower parts of the upper body, driving them forward as needed to walk or climb.
Additional crutches provide a supplemental source of security and stability for the user, and can be used while walking or lifting oneself up from a wheelchair.
Altogether, the ReWalk Personal System costs about $70,000.
While the ReWalk goes a long way in helping people with spinal cord injuries gain mobility, it is not for everyone. Users must meet specific spinal cord injury conditions in order to benefit from using the ReWalk.
The spinal cord is divided into various segmental levels —seven neck, or cervical, vertebrae, 12 chest, or thoracic, vertebrae, five back, or lumbar, vertebrae and five tail, or sacral, vertebrae — corresponding to the sections of the body that the spinal nerves control.
The ReWalk has only been approved for patients suffering from spinal cord injuries from the seventh thoracic vertebra (T7) to the last lumbar vertebra (L5). It cannot be worn by patients with heart or lung conditions or those who have had a history of severe neurological injury beyond that of a spinal cord injury. In addition, users must be able to possess mobility in the arms and shoulders in order to operate the ReWalk.
ReWalk’s entry to the market raises hopes for its ascension into popular usage for hundreds of thousands of people.
Capitalizing on the successes of ReWalk, the exoskeleton company ReWalk Robotics already has plans to adapt the device to people who are diagnosed with other disabilities, such as cerebral palsy.