LE-IST: Evaluation of an Advanced Lower Extremity Neuroprostheses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: A 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. |
Device: IST-16 (16-channel implanted stimulator-telemeter)
Pre-surgical exercise with surface electrical stimulation, surgery including electrode insertion and IST-16 stimulator/telemeter implantation, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.
|
Outcome Measures
Primary Outcome Measures
- Device reliability and technical performance measuring changes in standing 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 standing 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 walking 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 walking 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition
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Skeletal maturity
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Ability to understand and sign informed consents
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Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing)
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Intact and electrically excitable lower motor neurons
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Greater than 6 months since injury or onset
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Range of motion within normal limits
Exclusion Criteria:
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Pacemaker
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Cardiac arrythmia
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Pregnancy
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Contractures of any major joint of upper or lower extremities
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Uncontrolled seizure disorder
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Obesity
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Untreated substance abuse
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Immunodeficiency
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Frequent urinary tract infections
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Presence of decubitis ulcers
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Acute or chronic psychological problems
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Acute orthopaedic problems
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Pulmonary compromise
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Renal compromise
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Circulatory compromise
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History of spontaneous fractures or insulin dependent diabetes
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio | United States | 44106 |
| 2 | MetroHealth System | Cleveland | Ohio | United States | 44109 |
Sponsors and Collaborators
- Case Western Reserve University
- National Institutes of Health (NIH)
- US Department of Veterans Affairs
Investigators
- Principal Investigator: Ronald J Triolo, Ph.D., Case Western Reserve University
- Principal Investigator: Musa L Audu, Ph.D., Louis Stokes Cleveland VA Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Agarwal S, Triolo RJ, Kobetic R, Miller M, Bieri C, Kukke S, Rohde L, Davis JA Jr. Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury. J Rehabil Res Dev. 2003 May-Jun;40(3):241-52.
- Bogie KM, Triolo RJ. Effects of regular use of neuromuscular electrical stimulation on tissue health. J Rehabil Res Dev. 2003 Nov-Dec;40(6):469-75.
- Davis JA Jr, Triolo RJ, Uhlir J, Bieri C, Rohde L, Lissy D, Kukke S. Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? J Rehabil Res Dev. 2001 Nov-Dec;38(6):609-17.
- Dutta A, Kobetic R, Triolo RJ. Ambulation after incomplete spinal cord injury with electromyogram-triggered functional electrical stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:5408-11.
- Uhlir JP, Triolo RJ, Davis JA Jr, Bieri C. Performance of epimysial stimulating electrodes in the lower extremities of individuals with spinal cord injury. IEEE Trans Neural Syst Rehabil Eng. 2004 Jun;12(2):279-87.
- EB-001889
- NS-040547