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Stroke SequelaeNCT07211672

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

A study testing Multichannel functionnal electrical stimulation in people with Stroke Sequelae and Stroke ( 3 Months After Onset), run by TOPMED.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Multichannel functionnal electrical stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
No sites listed yet
Study dates
31 Oct 2025to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Edith Martin, Ph. D contact

418-780-1301

emartin@topmed.ca

Gabriel Diamond Ouellette, Ph.D contact

gdiamondouellette@topmed.ca

About this study

Official title: Effictiveness of Multichannel Functionnal Electrical Motor and Sensorimotor Stimulation for Subchronic Stroke Gait Rehabilitation

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.
Being tested
Multichannel functionnal electrical stimulation
Keywords
Subchronic stroke, Gait, Rehabilitation, Functionnal electrical stimulation, Motor, Sensorimotor, Multichannel
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multichannel functionnal electrical stimulationDevice

    Also called Neuroskin

    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).

Study groups in NCT07211672
Study groupRoleWhat they receive
Multichannel functionnal electrical stimulationExperimentalThe 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.
Receives: Device: Multichannel functionnal electrical stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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).

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

  3. 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).

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

Secondary outcomes (21)

  1. Change in walking endurance at intermediate evaluation

    Walking endurance was evaluated with a 6 minute walking test. Participants begin walking at the start of the timer. When the participant can't continue walking or when the timer stops, whichever comes first, the distance covered is measured. The distance is covered in a rectangle on flat ground so as to reduce deceleration during turns. Participants performed 2 trials, the maximal distance was kept as the score for the evaluation. Questionnaires were performed in between the two trials, which were separated by at least 30 minutes, so the participants could rest. The measure is calculated using this formula:

    Change at V2 = Distance at V2[intermediate] - Distance at V1[baseline]

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

  2. Change in walking endurance at post-treatment evaluation

    Walking endurance was evaluated with a 6 minute walking test. Participants begin walking at the start of the timer. When the participant can't continue walking or when the timer stops, whichever comes first, the distance covered is measured. The distance is covered in a rectangle on flat ground so as to reduce deceleration during turns. Participants performed 2 trials, the maximal distance was kept as the score for the evaluation. Questionnaires were performed in between the two trials, which were separated by at least 30 minutes, so the participants could rest. The measure is calculated using this formula:

    Change at V3 = Distance at V3[post-treatment] - Distance at V1[baseline]

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

  3. Change in walking endurance at follow-up evaluation

    Walking endurance was evaluated with a 6 minute walking test. Participants begin walking at the start of the timer. When the participant can't continue walking or when the timer stops, whichever comes first, the distance covered is measured. The distance is covered in a rectangle on flat ground so as to reduce deceleration during turns. Participants performed 2 trials, the maximal distance was kept as the score for the evaluation. Questionnaires were performed in between the two trials, which were separated by at least 30 minutes, so the participants could rest. The measure is calculated using this formula:

    Change at V4 = Distance at V4[follow-up] - Distance at V1[baseline]

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

  4. Change in muscle spasticity at intermediate evaluation

    Muscle spasticity was assessed with the Modified Ashworth Scale for 7 lower body muscles groups(Hip: flexors, extensors and adductors, Knee: flexors and extensors, Ankle: flexors and evertors). Each side was scored independently. This scale has 6 levels, minimum is 0(no increase in tone), maximum is 5(segment is rigid in flexion or extension). The value for each visit is the sum of all scores(all muscle group on both sides). The measure is calculated using this formula:

    Change at V2 = Spasticity at V2[intermediate] - Spasticity at V1[baseline]

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

  5. Change in muscle spasticity at post-treatment evaluation

    Muscle spasticity was assessed with the Modified Ashworth Scale for 7 lower body muscles groups(Hip: flexors, extensors and adductors, Knee: flexors and extensors, Ankle: flexors and evertors). Each side was scored independently. This scale has 6 levels, minimum is 0(no increase in tone), maximum is 5(segment is rigid in flexion or extension). The value for each visit is the sum of all scores(all muscle group on both sides). The measure is calculated using this formula:

    Change at V3 = Spasticity at V3[post-treatment] - Spasticity at V1[baseline]

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

  6. Change in muscle spasticity at follow-up evaluation

    Muscle spasticity was assessed with the Modified Ashworth Scale for 7 lower body muscles groups(Hip: flexors, extensors and adductors, Knee: flexors and extensors, Ankle: flexors and evertors). Each side was scored independently. This scale has 6 levels, minimum is 0(no increase in tone), maximum is 5(segment is rigid in flexion or extension). The value for each visit is the sum of all scores(all muscle group on both sides). The measure is calculated using this formula:

    Change at V4 = Spasticity at V4[follow-up] - Spasticity at V1[baseline]

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

  7. Change in muscle strength at intermediate evaluation

    Muscle strength was assessed on both sides for 10 lower body muscle groups with the Medical Research Council scale for muscle strength. Muscle groups were hip flexors, hip extensors, hip abductors, hip adductors, knee flexors, knee extensors, tibialis anterior, triceps surae, tibialis posterior, fibular muscles. This scale has 6 levels, minimum is 0(no visible contraction), maximum is 5(normal muscle strength). The value for each visit is the sum of all scores(all muscle groups on both sides). The measure is calculated using this formula:

    Change at V2 = Strength at V2[intermediate] - Strength at V1[baseline]

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

  8. Change in muscle strength at post-treatment evaluation

    Muscle strength was assessed on both sides for 10 lower body muscle groups with the Medical Research Council scale for muscle strength. Muscle groups were hip flexors, hip extensors, hip abductors, hip adductors, knee flexors, knee extensors, tibialis anterior, triceps surae, tibialis posterior, fibular muscles. This scale has 6 levels, minimum is 0(no visible contraction), maximum is 5(normal muscle strength). The value for each visit is the sum of all scores(all muscle groups on both sides). The measure is calculated using this formula:

    Change at V3 = Strength at V3[post-treatment] - Strength at V1[baseline]

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

  9. Change in muscle strength at follow-up evaluation

    Muscle strength was assessed on both sides for 10 lower body muscle groups with the Medical Research Council scale for muscle strength. Muscle groups were hip flexors, hip extensors, hip abductors, hip adductors, knee flexors, knee extensors, tibialis anterior, triceps surae, tibialis posterior, fibular muscles. This scale has 6 levels, minimum is 0(no visible contraction), maximum is 5(normal muscle strength). The value for each visit is the sum of all scores(all muscle groups on both sides). The measure is calculated using this formula:

    Change at V4 = Strength at V4[follow-up] - Strength at V1[baseline]

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

  10. Change in ambulation capacity at intermediate evaluation

    The ambulation capacity is evaluated with the modified emory functional ambulation profile(Baer and Wolf, 2001). It is a timed measure of walking under 5 environnemental challenges, the score is the sum of all timed activities. Minimal value is 0, maximal value is infinite. The measure is calculated using this formula: Change at V2 = Score at V2[intermediate] - Score at V1[baseline]

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

  11. Change in ambulation capacity at post-treatment evaluation

    The ambulation capacity is evaluated with the modified emory functional ambulation profile(Baer and Wolf, 2001). It is a timed measure of walking under 5 environnemental challenges, the score is the sum of all timed activities. Minimal value is 0, maximal value is infinite. The measure is calculated using this formula: Change at V3 = Score at V3[post-treatment] - Score at V1[baseline]

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

  12. Change in ambulation capacity at follow-up evaluation

    The ambulation capacity is evaluated with the modified emory functional ambulation profile(Baer and Wolf, 2001). It is a timed measure of walking under 5 environnemental challenges, the score is the sum of all timed activities. Minimal value is 0, maximal value is infinite. The measure is calculated using this formula: Change at V4 = Score at V4[follow-up] - Score at V1[baseline]

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

  13. Change in health perception at intermediate evaluation

    Health perception was assessed with the EQ-5D-5L developped by EuroQol Research Foundation. This questionnaire as 5 items(mobility, self-care, usual activities, pain/discomfort, anxiety/depression) all of which have 5 levels(minimum: no problems[1], maximum : incapacitity/extreme problems[5]). The EQ-5D index is then calculated according to the country specific formula using the health state data(Canada=EQ-VT v1.0). The EQ VAS is a visual analog scale ranging from 0(worst health you can imagine) to 100(best health you can imagine). The measure is calculated using this formula:

    Change at V2 = Variable at V2[intermediate] - Variable at V1[baseline]

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

  14. Change in health perception at post-treatment evaluation

    Health perception was assessed with the EQ-5D-5L developped by EuroQol Research Foundation. This questionnaire as 5 items(mobility, self-care, usual activities, pain/discomfort, anxiety/depression) all of which have 5 levels(minimum: no problems[1], maximum : incapacitity/extreme problems[5]). The EQ-5D index is then calculated according to the country specific formula using the health state data(Canada=EQ-VT v1.0). The EQ VAS is a visual analog scale ranging from 0(worst health you can imagine) to 100(best health you can imagine). The measure is calculated using this formula:

    Change at V3 = Variable at V3[post-treatment] - Variable at V1[baseline]

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

  15. Change in health perception at follow-up evaluation

    Health perception was assessed with the EQ-5D-5L developped by EuroQol Research Foundation. This questionnaire as 5 items(mobility, self-care, usual activities, pain/discomfort, anxiety/depression) all of which have 5 levels(minimum: no problems[1], maximum : incapacitity/extreme problems[5]). The EQ-5D index is then calculated according to the country specific formula using the health state data(Canada=EQ-VT v1.0). The EQ VAS is a visual analog scale ranging from 0(worst health you can imagine) to 100(best health you can imagine). The measure is calculated using this formula:

    Change at V4 = Variable at V4[follow-up] - Variable at V1[baseline]

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

  16. Change in satisfaction with the treatment device at intermediate evaluation

    Patient's satisfaction with the treatment device(Neuroskin) was assessed with the french version of Quebec User Evaluation of Satisfaction with Asisistive Technology (QUEST 2.0). This questionnaire has 16 items, each item uses a 5 point Likert scale(minimum: not satisfied at all[1], maximum: very satisfied[5]). Three variables are analysed:

    1. Satisfaction with the technology: Average of 8 items(minimum: not satisfied at all[1], maximum: very satisfied[5]).
    2. Satisfaction with the services: Average of 4 items(minimum: not satisfied at all[1], maximum: very satisfied[5]).
    3. Total score: Average of all 12 items(minimum: not satisfied at all[1], maximum: very satisfied[5]).

    The measure is calculated using this formula:

    Change at V2 = Variable at V2[intermediate] - Variable at V1[baseline]

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

  17. Change in satisfaction with the treatment device at post-treatment evaluation

    Patient's satisfaction with the treatment device(Neuroskin) was assessed with the french version of Quebec User Evaluation of Satisfaction with Asisistive Technology (QUEST 2.0). This questionnaire has 16 items, each item uses a 5 point Likert scale(minimum: not satisfied at all[1], maximum: very satisfied[5]). Three variables are analysed:

    1. Satisfaction with the technology: Average of 8 items(minimum: not satisfied at all[1], maximum: very satisfied[5]).
    2. Satisfaction with the services: Average of 4 items(minimum: not satisfied at all[1], maximum: very satisfied[5]).
    3. Total score: Average of all 12 items(minimum: not satisfied at all[1], maximum: very satisfied[5]).

    The measure is calculated using this formula:

    Change at V3 = Variable at V3[post-treatment] - Variable at V1[baseline]

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

  18. Change in satisfaction with the treatment device at follow-up evaluation

    Patient's satisfaction with the treatment device(Neuroskin) was assessed with the french version of Quebec User Evaluation of Satisfaction with Asisistive Technology (QUEST 2.0). This questionnaire has 16 items, each item uses a 5 point Likert scale(minimum: not satisfied at all[1], maximum: very satisfied[5]). Three variables are analysed:

    1. Satisfaction with the technology: Average of 8 items(minimum: not satisfied at all[1], maximum: very satisfied[5]).
    2. Satisfaction with the services: Average of 4 items(minimum: not satisfied at all[1], maximum: very satisfied[5]).
    3. Total score: Average of all 12 items(minimum: not satisfied at all[1], maximum: very satisfied[5]).

    The measure is calculated using this formula:

    Change at V4 = Variable at V4[follow-up] - Variable at V1[baseline]

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

  19. Change in functional ambulation classification at intermediate evaluation

    The ambulation capacity is evaluated with the New Functional Ambulation Classification(NFAC) Brun, V., et al. "" Annales de readaptation et de medecine physique. Vol. 43. No. 1. Elsevier Science, 2000. This classification uses 9 levels to differentiate the patient's walking performance with or without help. Minimum score is 0(patient cannot walk or need's help from more than one person), maximum score is 8(patient can walk on flat ground and go up and down stairs without lateral support or using the hand railing). The measure is calculated using this formula:

    Change at V2 = Score at V2[intermediate] - Score at V1[baseline]

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

  20. Change in functional ambulation classification at post-treatment evaluation

    The ambulation capacity is evaluated with the New Functional Ambulation Classification(NFAC) Brun, V., et al. "" Annales de readaptation et de medecine physique. Vol. 43. No. 1. Elsevier Science, 2000. This classification uses 9 levels to differentiate the patient's walking performance with or without help. Minimum score is 0(patient cannot walk or need's help from more than one person), maximum score is 8(patient can walk on flat ground and go up and down stairs without lateral support or using the hand railing). The measure is calculated using this formula:

    Change at V3 = Score at V3[post-treatment] - Score at V1[baseline]

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

  21. Change in functional ambulation classification at follow-up evaluation

    The ambulation capacity is evaluated with the New Functional Ambulation Classification(NFAC) Brun, V., et al. "" Annales de readaptation et de medecine physique. Vol. 43. No. 1. Elsevier Science, 2000. This classification uses 9 levels to differentiate the patient's walking performance with or without help. Minimum score is 0(patient cannot walk or need's help from more than one person), maximum score is 8(patient can walk on flat ground and go up and down stairs without lateral support or using the hand railing). The measure is calculated using this formula:

    Change at V4 = Score at V4[follow-up] - Score at V1[baseline]

    Measured: At baseline evaluation and post-treatment evaluation(16 to 20 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2025
  2. Study start31 Oct 2025 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07211672
Sponsor's protocol ID
RD-25-0532
Status last verified
Oct 2025
First submitted
1 Oct 2025
Last updated
8 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Multichannel functionnal electrical stimulation in people with Stroke Sequelae and Stroke ( 3 Months After Onset), run by TOPMED.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Edith Martin, Ph. D (418-780-1301, emartin@topmed.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in walking speed at intermediate evaluation (time frame: At baseline evaluation and the intermediate evaluation(4 to 6 weeks after baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07211672.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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