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

NCT07211672 | Not Yet Recruiting

• 1 other identifier: RD-25-0532
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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:

• 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.

Conditions

Stroke Sequelae; Stroke ( 3 Months After Onset)

Keywords

Subchronic stroke; Gait; Rehabilitation; Functionnal electrical stimulation; Motor; Sensorimotor; Multichannel

Outcome Measures

Primary Outcomes (3)

• Change in walking speed at intermediate evaluation

  Walking speed was evaluated with a 10 meters walking test without any electrical stimulation. Two trials were done for each evaluation, one at comfortable speed and one at maximal speed. This test is done with a flying start, therefore participants are already at said walking speed when the timer begins. The timer stops when they complete the 10 meters distance. The distance is covered in a straight line. For each speed(comfortable and maximal), the measure is calculated using this formula: Change at V2 = Speed at V2(intermediate) - Speed at V1(baseline).

  At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline)

• Change in walking speed at post-treatment evaluation

  Walking speed was evaluated with a 10 meters walking test. Two trials were done for each evaluation, one at comfortable speed and one at maximal speed. This test is done with a flying start, therefore participants are already at said walking speed when the timer begins. The timer stops when they complete the 10 meters distance. The distance is covered in a straight line. For each speed(comfortable and maximal), the measure is calculated using this formula: Change at V3 = Speed at V3(post-treatment) - Speed at V1(baseline).

  At baseline evaluation and the post-treatment evaluation(8 to 12 weeks after baseline)

• Change in walking speed at follow-up evaluation

  Walking speed was evaluated with a 10 meters walking test. Two trials were done for each evaluation, one at comfortable speed and one at maximal speed. This test is done with a flying start, therefore participants are already at said walking speed when the timer begins. The timer stops when they complete the 10 meters distance. The distance is covered in a straight line. For each speed(comfortable and maximal), the measure is calculated using this formula: Change at V4 = Speed at V4(follow-up) - Speed at V1(baseline).

  At baseline evaluation and the follow-up evaluation(16 to 20 weeks after baseline)

Secondary Outcomes (21)

• Change in walking endurance at intermediate evaluation

  At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline)

• Change in walking endurance at post-treatment evaluation

  At baseline evaluation and the post-treatment evaluation(8 to 12 weeks after baseline)

• Change in walking endurance at follow-up evaluation

  At baseline evaluation and the follow-up evaluation(16 to 20 weeks after baseline)

• Change in muscle spasticity at intermediate evaluation

  At baseline evaluation and intermediate evaluation(4 to 6 weeks after baseline)

• Change in muscle spasticity at post-treatment evaluation

  At baseline evaluation and post-treatment evaluation (8 to 12 weeks after baseline)

Study Arms (1)

Multichannel functionnal electrical stimulation

EXPERIMENTAL

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.

Device: Multichannel functionnal electrical stimulation

Interventions

Multichannel functionnal electrical stimulation DEVICE

The participants completed 24 gait rehabilitation sessions over the course of 8 to 12 weeks. Each session lasted between 30 minutes and 1 hour. A minimum of 2 days seperated two consecutive sessions. The number of sessions was used for standardization of the protocol instead of duration of treatment. Four evaluations were completed throughout the protocol. Baseline evaluation(V1) was completed between 2 and 7 days before the first rehabilitation session. Intermediate evaluation(V2) was completed between 2 and 7 days after the 12th rehabilitation session, in other words 4 to 6 weeks after the baseline evaluation (V1) . Post-treatment evaluation(V3) was completed between 2 and 7 days after the 24th rehabilitation session, in other words 8 to 12 weeks after the baseline evaluation (V1). Follow-up evaluation(V4) was completed 2 months(60 days) after the 24th rehabilitation session, in other words 16 to 20 weeks after the baseline evaluation (V1).

Also known as: Neuroskin

Multichannel functionnal electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• TOPMED: lead
• Kurage SAS: collaborator
• Natural Sciences and Engineering Research Council, Canada: collaborator
• Clinique Synapse - Réadaptation & Vie Active: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Edith Martin, Ph. D

CONTACT

418-780-1301; emartin@topmed.ca

Gabriel Diamond Ouellette, Ph.D

CONTACT

gdiamondouellette@topmed.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10