Evaluation of Advanced Lower Extremity Neuroprostheses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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.
Arms & Interventions
Implant
Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.
Intervention: IST (Implanted Stimulator-Telemeter) (Device)
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)
Investigators
Ronald J. Triolo
Biomedical Engineer
Case Western Reserve University