Evaluation of an Advanced Lower Extremity Neuroprostheses
Start Date
6/1/2018
Completion Date
12/31/2027
Summary
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.
Detailed Description
Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system. Patients are followed at 6 and 12 months after discharge and then annually thereafter.
Eligibility Criteria
Age Range: 21 years to 75 years
Interventions
IST (Implanted Stimulator-Telemeter)
Conditions
Locations
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio 44106
United States
MetroHealth System
Cleveland, Ohio 44109
United States