A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit (RW)
The ReWalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other severe walking impairments. The device promises to restore the dignity of disabled persons, enabling them to work and improve their general health and quality of life, as well as significantly reduce medical and other related expenses.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Study of the ReWalk Motorized Exoskeleton Suit That Enables Individuals With Lower Limbs Impairment to Walk and to Perform Other Basic Mobility Functions.|
- Observation and subject feedback [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- subject tolerance [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
A group of paraplegics.
Device: ReWalk - a motorized exoskeleton suit
The subject will wear the ReWalk suit and have training sessions for walking with the device.
Other Name: Exoskeleton suit
The ReWalk comprises light wearable brace support suit, which integrates DC motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system. It is snugly fitted on the body and worn underneath the clothing, if desired. ReWalk is a new realization of the Powered Exoskeleton concept, first tried about fifty years ago with no success. Employing an innovative, non-robotic design approach, it uniquely matches the user's capabilities with the control mechanisms. Upper-body movements of the user are detected and used to initiate and maintain walking processes. User stability and safety during ambulation is secured by concurrent use of safety aids such as crutches for walking and railing for stairs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627107
|Sheba Medical Center, Neurological Rehabilitation Department|
|Tel-Hashomer, Israel, 52621|
|Principal Investigator:||Gabi Zeilig, MD||Sheba Medical Center|