NCT00623389Recruiting
Evaluation of an Advanced Lower Extremity Neuroprostheses
Evaluation of Advanced Lower Extremity Neuroprostheses
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 24 Jan 2008
- Start date
- 1 Jun 2018
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Case Western Reserve University
- Diseases
- Stroke
- NCT number
- NCT00623389
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 1 Jun 2018 to the primary completion date, 31 Dec 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Phase I Inclusion Criteria
- Skeletal maturity and ability to sign informed consent (\>18 years)
- 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
- Innervated and excitable lower extremity and trunk musculature
- Adequate social support and stability
- Willingness to comply with follow-up procedures
- Phase I Exclusion Criteria
- Non-English speaking
- Females who are pregnant
- Current pressure injuries that would be exacerbated by study activities
- 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
- History of spontaneous fractures or other evidence of excessively low bone density
- History of vestibular dysfunction, balance problems, or spontaneous falls
- Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Louis Stokes Cleveland VA Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| MetroHealth System Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.