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.
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)
Multiple strokes
Does not respond sufficiently to electrical stimulation
Contraindication to electrical stimulation
Comprehension, psychiatric or cognitive problems that could hamper the protocol
Single group
Multichannel functionnal electrical stimulation
DeviceThe 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).
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).
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).
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).
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\[baseline\]
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\[baseline\]
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\[baseline\]
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\[baseline\]
Click on the lead sponsor to view all of their trials.
TOPMED
Lead sponsor
Kurage SAS
Collaborator
Natural Sciences and Engineering Research Council, Canada
Collaborator
Clinique Synapse - Réadaptation & Vie Active
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
