Study of an Implanted Electrical Stimulation Device to Improve Mobility and Balance in Adults with Paralysis

What this Trial Is About

Researchers are evaluating an implanted functional electrical stimulation FES system designed to help people with paralysis improve their ability to exercise, stand, step, and maintain balance. The study focuses on adults with various types of paralysis, including spinal cord injuries, stroke, tetraplegia, and paraplegia. This research aims to understand how the implanted neuroprosthesis impacts mobility and functional abilities over time. Participants undergo surgery to have electrodes implanted into muscles of the trunk and legs, which are connected to an implanted stimulator-telemeter device. After surgery, they receive training in standing, transfers, and advanced mobility skills using the FES system. The study includes prescribed exercise, functional training, and rehabilitation with the device, followed by laboratory assessments of strength, balance, and function both with and without the system. Home-based training is provided before discharge for ongoing use at home. During the study, participants are assessed at discharge and then followed up at 6 months, 12 months, and annually thereafter. Evaluations include measuring standing duration, standing loads, walking distance, and walking duration compared to baseline. Researchers also assess changes in daily functional activities and monitor the technical performance and reliability of the implanted components throughout the study period, which can last up to several years.

Evaluation of an Advanced Lower Extremity Neuroprostheses