Clinical Implementation of Multichannel Functional Electrical Stimulation Device for Gait Rehabilitation in Subchronic Stroke: A Feasibility Study

TOPMED

Status: Not yet enrolling

Conditions: Stroke ( 3 Months After Onset); Stroke Sequelae

Treatments: Device: Multichannel functionnal electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07211672

RD-25-0532

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Multichannel functionnal electrical stimulation

Experimental group

Description:

The participants will complete 24 rehabilitation sessions over the course of 8 to 12 weeks. During each rehab session, they will receive functionnal electrical stimulation only on their paretic side, the non-paretic side will not receive functionnal electrical stimulation.

Treatment:

Device: Multichannel functionnal electrical stimulation