Trials / Recruiting
RecruitingNCT00623389
Evaluation of an Advanced Lower Extremity Neuroprostheses
Evaluation of Advanced Lower Extremity Neuroprostheses
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Case Western Reserve University · Academic / Other
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
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, 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 implanted components. Home-based training follows prior to discharge for home use of the system. Patients are followed at 6 and 12 months after discharge and then annually thereafter.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | IST (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. |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
- First posted
- 2008-02-26
- Last updated
- 2025-06-15
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT00623389. Inclusion in this directory is not an endorsement.