Evaluation of an Advanced Lower Extremity Neuroprostheses (NCT00623389) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of an Advanced Lower Extremity Neuroprostheses
United States10 participantsStarted 2018-06-01
Plain-language 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.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Skeletal maturity and ability to sign informed consent (\>18 years)
. 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
. Innervated and excitable lower extremity and trunk musculature
. Adequate social support and stability
. Willingness to comply with follow-up procedures
Exclusion criteria
. Non-English speaking
. Females who are pregnant
. Current pressure injuries that would be exacerbated by study activities
. 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
. History of spontaneous fractures or other evidence of excessively low bone density
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge
Timeframe: Change from immediately after intervention and 1 year after intervention
2
Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge
Timeframe: Change from immediately after intervention and 1 year after intervention
3
Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
Timeframe: Change from immediately after intervention and 1 year after intervention
4
Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge
Timeframe: Change from immediately after intervention and 1 year after intervention