Evaluation of Advanced Lower Extremity Neuroprostheses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Case Western Reserve University
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
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.
Investigators
Ronald J. Triolo
Biomedical Engineer
Case Western Reserve University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
Time Frame: Change from immediately after intervention and 1 year after intervention
Repeated measures of walking distance in meters
Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge
Time Frame: Change from immediately after intervention and 1 year after intervention
Repeated measures of arm/leg loading measured in Kg
Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge
Time Frame: Change from immediately after intervention and 1 year after intervention
Repeated measures of standing duration in minutes
Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge
Time Frame: Change from immediately after intervention and 1 year after intervention
Repeated measures of walking time in minutes
Secondary Outcomes
- Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge(Change from immediately after intervention and 1 year after intervention)