Objective: The aim of this study was to assess the safety and performance of ReWalk in enabling people with paraplegia due to spinal cord injury to carry out routine ambulatory functions.
Design: This was an open, noncomparative, nonrandomized study of the safety and performance of the ReWalk powered exoskeleton. All 12 subjects have completed the active intervention; three remain in long-term follow-up.
Results: After training, all subjects were able to independently transfer and walk, without human assistance while using the ReWalk, for at least 50 to 100 m continuously, for a period of at least 5 to 10 mins continuously and with velocities ranging from 0.03 to 0.45 m/sec (mean, 0.25 m/sec). Excluding two subjects with considerably reduced walking abilities, average distances and velocities improved significantly. 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.
Conclusions: ReWalk holds considerable potential as a safe ambulatory powered orthosis for motor-complete thoracic-level spinal cord injury patients. Most subjects achieved a level of walking proficiency close to that needed for limited community ambulation. A high degree of performance variability was observed across individuals. Some of this variability was explained by level of injury, but other factors have not been completely identified. Further development and application of this rehabilitation tool to other diagnoses are expected in the future.