A Phase 1 interventional study of IRS-8 (8 channel implanted receiver stimulator) in Stroke, Partial Paralysis and Spinal Cord Injury, sponsored by Louis Stokes VA Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-14.
Sponsored by Louis Stokes VA Medical Center · Phase 1, Interventional, and Treatment
The purpose of this research study is to evaluate the effectiveness of functional electrical stimulation (FES) provided by an implanted pulse generator (IPG) in correcting hip, knee and ankle function to improve walking in people with partial paralysis.
In a surgical procedure electrodes are inserted into muscles of the lower extremities to correct hip, knee and ankle function. The electrode leads are connected to an implanted pulse generator located in the abdomen. After a typical post-operative period of two to five days, the recipient will be discharged home for two to six weeks of moderate activity. Following a 6 week period of laboratory exercise and training, functional use of the neuroprosthesis will begin at home and in the community with follow-up evaluations at 1, 3, 6 and 12 months. Laboratory assessments include walking speed and distance, physiologic cost, muscle strength, measure of spasticity, and gait analysis with and without stimulation. A number of self-reporting instruments are administered to capture individual's participation, quality of life and various aspects of perceived community ambulation.
601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.
This study's planned enrollment of 6 is below the median of 46 across 444 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →Louis Stokes VA Medical Center is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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: IRS-8 (8 channel implanted receiver stimulator)
Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities
Also known as: Implanted pulse generator for ambulation, Implanted FES system for lower extremities, Implated FES system for ambulation, FES system for walking, Implanted neuroprosthesis for gait correction, Gait correction in partial paralysis
The effect of functional electrical stimulation of the hip, knee and ankle muscles to improve walking in people with partial paralysis
Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without stimulation to determine if individuals are able to improve community ambulatory access with use of neuroprosthesis.
Time frame: up to 36 months
Feasibility of initiating a step with a trigger from an accelerometer incorporated in the external control unit to adjust to environmental circumstances and situations encountered in community ambulation
Experiments involving analyses of individual's speed, distance and quality of walking will be performed both with and without accelerometer triggered stepping to determine if individuals are able to adjust to environmental circumstances and situations encountered in community ambulation.
Time frame: up to 36 months
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Louis Stokes VA Medical Center