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Evaluation of an Advanced Lower Extremity Neuroprostheses
Recruiting
Evaluation of Advanced Lower Extremity Neuroprostheses
Who can join
Ages 21 to 75 · All sexes
Full eligibility criteria
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 study activities 4. Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities 5. History of spontaneous fractures or other evidence of excessively low bone density 6. History of vestibular dysfunction, balance problems, or spontaneous falls 7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
About the study
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.
What is being tested
- IST (Implanted Stimulator-Telemeter) (device)
Sponsor: Case Western Reserve University · Participants: 10 · Started: Jun 1, 2018
Contact the study team
- Lisa M Lombardo, MPT · Phone: 216-791-3800
- Maura Malenchek, PTA · Phone: 216-791-3800
Official record on ClinicalTrials.gov — NCT00623389
Locations in the U.S.
| Ohio | Louis Stokes Cleveland VA Medical Center, Cleveland MetroHealth System, Cleveland |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.