The ReWalk powered exoskeleton to restore ambulatory function to individuals with thoracic-level motor-complete spinal cord injury.
This open, non-comparative, non-randomized study was performed to assess the safety and performance of the ReWalk powered exoskeleton in enabling people with paraplegia to ambulate. This study comprised 12 subjects with paraplegia due to spinal cord injury who completed the active intervention. Subjects were trained for up to 24 sessions of 60- to 90-min duration over approximately 8 weeks. Near the completion of training, subjects had a performance evaluation visit that consisted of a 6-min walk test, a 10-m walk test, and a gait laboratory evaluation including three-dimensional motion capture and temporo-spatial data. After training, while using the ReWalk 10 of the 12 subjects were able to independently transfer and walk, without assistance, for at least 50 to 100 meters continuously, for a period of at least 5 to 10 mins continuously, and with velocities ranging from 0.03 to 0.45 m/sec. Some subjects reported improvements in pain, bowel and bladder function, and spasticity during the trial. All subjects had strong positive comments regarding the emotional/psychosocial benefits of the use of ReWalk. Most subjects achieved a level of walking proficiency close to that needed for limited community ambulation. The research shows that the ReWalk holds considerable potential as a safe ambulatory powered orthosis for patients with motor-complete thoracic-level SCI.
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