Feasibility and safety of training with an exoskeletal robotic device for Japanese individuals with spinal cord injuries: a retrospective study.

[Purpose] To provide practical suggestions for the clinical application of robotic exoskeletal orthoses, we conducted a retrospective survey of patients with spinal cord lesions. [Participants and Methods] We studied the records of patients with spinal cord lesions who were trained using the ReWalk system (ReWalk Robotics). These records included the neurological level of injury, American Spinal Injury Association Impairment Scale, time since injury, total training time, adverse events, level of assistance required, dropouts, and reasons for dropout. [Results] Twenty-eight patients were trained with the ReWalk system at least once. Three of them underwent a modified training program owing to their severe paralysis. Eight patients dropped out from the regular training program or required a moderate or greater level of assistance. Twelve patients regained ambulation with the ReWalk system in indoor environments on a flat surface. The remaining five achieved ambulation with the ReWalk system in outdoor environments, including on slopes. Thirty-four adverse events were recorded. These events resolved within a few days with rest, adhesive dressing bandages, or other means. [Conclusion] The feasibility and safety of the training program and the outcomes achieved were comparable to those in previous studies. The device fit may need more careful attention.