Evaluation of an Advanced Lower Extremity Neuroprostheses for Paralysis
This study is evaluating a surgically implanted system called IST (Implanted Stimulator-Telemeter) for people with paralysis from conditions like spinal cord injuries or stroke. The IST system uses electrical stimulation to help with exercise, standing, stepping, and balance. To join, you must be between 21 and 75 years old, have skeletal maturity, and have paralysis that is not ventilator-dependent, affecting your trunk and/or lower limbs. Researchers will measure how well the device works and its technical performance by looking at changes in how long you can stand, how much weight you can bear while standing, and how far you can walk, from immediately after the intervention to 12 months later. The current status of this study is unclear.
- Study design
- This is an interventional study with a planned enrollment of 10 participants. It is not specified if it is randomized or blinded.
- What's involved
- You would undergo surgery to implant electrodes and the IST system, followed by training and rehabilitation with the system. This includes exercise, functional training, and laboratory assessments, with home-based training before discharge.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed at 6 and 12 months after discharge, and then annually thereafter.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluation of an Advanced Lower Extremity Neuroprostheses
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Ronald J Triolo, Ph.D. · PRINCIPAL_INVESTIGATOR · Case Western Reserve University
- Musa L Audu, Ph.D. · PRINCIPAL_INVESTIGATOR · Louis Stokes Cleveland VA Medical Center
Who to contact
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What this trial measures
- Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after dischargeChange 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 dischargeChange 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 dischargeChange 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 dischargeChange from immediately after intervention and 1 year after intervention
Repeated measures of walking time in minutes