Evaluation of an Advanced Lower Extremity Neuroprostheses
- Conditions
- Spinal Cord InjuriesParalysisTetraplegiaStrokeParaplegia
- Interventions
- Device: IST-16 (16-channel implanted stimulator-telemeter)
- Registration Number
- NCT00623389
- Lead Sponsor
- Case Western Reserve University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Implant IST-16 (16-channel implanted stimulator-telemeter) 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.
- Primary Outcome Measures
Name Time Method Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge 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 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 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 Change from immediately after intervention and 1 year after intervention Repeated measures of walking time in minutes
- Secondary Outcome Measures
Name Time Method 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 Repeated measures of standing reach in cm, and transfer height in cm
Trial Locations
- Locations (2)
Louis Stokes Cleveland VA Medical Center
🇺🇸Cleveland, Ohio, United States
MetroHealth System
🇺🇸Cleveland, Ohio, United States