Evaluation of an Advanced Lower Extremity Neuroprostheses
Purpose
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.
Conditions
- Spinal Cord Injuries
- Stroke
- Paralysis
- Tetraplegia
- Paraplegia
Eligibility
- Eligible Ages
- Between 21 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition - Skeletal maturity - Ability to understand and sign informed consents - Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing) - Intact and electrically excitable lower motor neurons - Greater than 6 months since injury or onset - Range of motion within normal limits
Exclusion Criteria
- Pacemaker - Cardiac arrythmia - Pregnancy - Contractures of any major joint of upper or lower extremities - Uncontrolled seizure disorder - Obesity - Untreated substance abuse - Immunodeficiency - Frequent urinary tract infections - Presence of decubitis ulcers - Acute or chronic psychological problems - Acute orthopaedic problems - Pulmonary compromise - Renal compromise - Circulatory compromise - History of spontaneous fractures or insulin dependent diabetes
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Device Feasibility
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
Recruiting Locations
Cleveland, Ohio 44109
More Details
- Status
- Recruiting
- Sponsor
- Case Western Reserve University
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.