Status:
NOT_YET_RECRUITING
Clinical Implementation of Multichannel Functional Electrical Stimulation Device for Gait Rehabilitation in Subchronic Stroke: A Feasibility Study
Lead Sponsor:
TOPMED
Collaborating Sponsors:
Kurage SAS
Natural Sciences and Engineering Research Council, Canada
Conditions:
Stroke Sequelae
Stroke ( 3 Months After Onset)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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: ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT07211672
Start Date
October 31 2025
End Date
February 28 2027
Last Update
October 8 2025
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