Paralysis, Paraplegia, Spinal Cord Injuries, Stroke, Tetraplegia
Conditions
Keywords
Neurologic disorders, Rare disease, Spinal cord injuries, Stroke, Paraplegia, Tetraplegia
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.
Interventions
DEVICEIST (Implanted Stimulator-Telemeter)
Pre-surgical exercise with surface electrical stimulation, surgery including electrode and IST- implanted pulse generator insertion, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.
Sponsors
Case Western Reserve University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Phase I Inclusion Criteria 1. Skeletal maturity and ability to sign informed consent (\>18 years) 2. 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 3. Innervated and excitable lower extremity and trunk musculature 4. Adequate social support and stability 5. Willingness to comply with follow-up procedures Phase I
Exclusion criteria
1. Non-English speaking 2. Females who are pregnant 3. Current pressure injuries that would be exacerbated by study activities 4. 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 5. History of spontaneous fractures or other evidence of excessively low bone density 6. History of vestibular dysfunction, balance problems, or spontaneous falls 7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTLisa M Lombardo, MPT
CONTACTMaura Malenchek, PTA
PRINCIPAL_INVESTIGATORRonald J Triolo, Ph.D.
Case Western Reserve University
PRINCIPAL_INVESTIGATORMusa L Audu, Ph.D.
Louis Stokes Cleveland VA Medical Center
Outcome results
None listed