Clinical Implementation of Multichannel Functional Electrical Stimulation Device for Gait Rehabil… (NCT07211672) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Implementation of Multichannel Functional Electrical Stimulation Device for Gait Rehabilitation in Subchronic Stroke: A Feasibility Study
5 participantsStarted 2025-10-31
Plain-language summary
The goal of this interventional study is to evaluate the effect of multichannel functionnal electrical stimulation for subchronic stroke gait rehabilitation. The main questions it aims to answer are:
* Does this new therapy help improve walking speed?
* Evaluate other aspects of therapeutic effectiveness such as different aspects of walking endurance, mobility, postural instability and autonomy.
* Evaluate physiological aspects of autonomous gait such as spasticity, muscle strength and motor and sensorimotor recovery.
* Evaluate the acceptability of this new therapy and its effect on quality of life.
Who can participate
Age range
18 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:
* First ischemic stroke or first hemorrhagic supratentorial stroke
* Stroke must be unique
* Stoke event in the last 12 months but no sooner than 6 months (post subchronic stroke phase)
* Able to walk with the support of one person and one or multiple walking aids (new functionnal ambulatory classification equal to 1, 2 or 3)
* Able to tolerate and respond to electrical stimulation(Muscle strength grading level 3 while having the quadriceps stimulated)
* Willing to delay anti-spastic treatments like botulinic toxins and motor blockers until the end of the rehabilitation period included in the protocol
Exclusion Criteria:
* Multiple strokes
* Does not respond sufficiently to electrical stimulation
* Contraindication to electrical stimulation
* Comprehension, psychiatric or cognitive problems that could hamper the protocol
* Bilateral stroke or subtentorial stroke
* Able to walk without the support of one person (new functionnal ambulatory clssification equal to 4 or more)
* Needing help from more than one person to walk (new functionnal ambulatory classification equal to 0)
* Moderate spasticity in one or more lower body muscle groups (Modified Ashworth Scale Score \>= 2)
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
Change in walking speed at intermediate evaluation
Timeframe: At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline)
2
Change in walking speed at post-treatment evaluation
Timeframe: At baseline evaluation and the post-treatment evaluation(8 to 12 weeks after baseline)
3
Change in walking speed at follow-up evaluation
Timeframe: At baseline evaluation and the follow-up evaluation(16 to 20 weeks after baseline)