Status:
RECRUITING
Evaluation of an Advanced Lower Extremity Neuroprostheses
Lead Sponsor:
Case Western Reserve University
Conditions:
Spinal Cord Injuries
Stroke
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief 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 ...
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, patien...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00623389
Start Date
June 1 2018
End Date
December 31 2027
Last Update
June 15 2025
Active Locations (2)
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1
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, United States, 44106
2
MetroHealth System
Cleveland, Ohio, United States, 44109