Evaluation of Advanced Lower Extremity Neuroprostheses
Case Western Reserve University
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.
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 impla…
Eligibility
- Age range
- 21–75 years
- Sex
- All
- Healthy volunteers
- No
Phase I Inclusion Criteria 1. Skeletal maturity and ability to sign informed consent (\>18 years) 2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs 3. Innervated and excitable lower extremity and trunk musculature 4. Adequate social support and stability 5. Willingness to comply with follow-up procedures Phase I Exclusion Criteria 1. Non-English speaking 2. Females who are pregnant 3. Current pressure injuries that would be exacerbated by…
Interventions
- DeviceIST (Implanted Stimulator-Telemeter)
Pre-surgical exercise with surface electrical stimulation, surgery including electrode and IST- implanted pulse generator insertion, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.
Locations (2)
- Louis Stokes Cleveland VA Medical CenterCleveland, Ohio
- MetroHealth SystemCleveland, Ohio