NCT00623389 Evaluation of an Advanced Lower Extremity Neuroprostheses
| NCT ID | NCT00623389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Case Western Reserve University |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2018-06-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2018-06-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 of paralysis.
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.
Contact & Investigator
Ronald J Triolo, Ph.D.
PRINCIPAL INVESTIGATOR
Case Western Reserve University
Frequently Asked Questions
Who can join the NCT00623389 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 75 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00623389 currently recruiting?
Yes, NCT00623389 is actively recruiting participants. Contact the research team at lisa.lombardo2@va.gov for enrollment information.
Where is the NCT00623389 trial being conducted?
This trial is being conducted at Cleveland, United States, Cleveland, United States.
Who is sponsoring the NCT00623389 clinical trial?
NCT00623389 is sponsored by Case Western Reserve University. The principal investigator is Ronald J Triolo, Ph.D. at Case Western Reserve University. The trial plans to enroll 10 participants.