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

NCT ID: NCT07211672

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-02-28

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multichannel functionnal electrical stimulation

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.

Group Type: EXPERIMENTAL

Multichannel functionnal electrical stimulation

Intervention Type: 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).

Interventions

Multichannel functionnal electrical stimulation

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).

Intervention Type: DEVICE

Other Intervention Names

Neuroskin

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kurage SAS

OTHER

Sponsor Role: collaborator

Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role: collaborator

Clinique Synapse - Réadaptation & Vie Active

UNKNOWN

Sponsor Role: collaborator

TOPMED

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Edith Martin, Ph. D

Role: CONTACT

emartin@topmed.ca

418-780-1301

Gabriel Diamond Ouellette, Ph.D

Role: CONTACT

gdiamondouellette@topmed.ca

Other Identifiers

RD-25-0532

Identifier Type: -

Identifier Source: org_study_id