Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.

Study Overview
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Brief Summary
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In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy. In the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction. The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.

Official Title
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Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.

Conditions
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Stroke

Intervention / Treatment
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* Other: Fugl-Meyer Assessment (FMA)
* Other: Medical Research Concil (MRC)
* Other: 2 Minute Walk Test (2MWT)
* Other: Timed Up & Go Test
* Other: Modified Ashworth Scale
* Other: Postural Assessment Scale for Stroke
* Device: posturographic recording
* Other: vibration program
* Other: sham program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having had a stroke (with or without previous stroke) and being in the early subacute phase (between 14 days and 3 months of stroke). Responsible for a motor deficit in the right or left lower limb. No neurological history other than stroke. Exclusion Criteria: Multifocal stroke Patient having received a botulinum toxin injection to the lower limb to be vibrated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vibration program<br>a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. The program will apply a frequency of 100 Hz, with an amplitude of 1 mm | Other: Fugl-Meyer Assessment (FMA)<br>* assessment of motor skills : measurement of the intensity of reflexes, as well as an assessment of voluntary movements and motor coordination Score from 0 to 34<br>Other: Medical Research Concil (MRC)<br>* evaluation of muscular strength score from 0 to 5<br>Other: 2 Minute Walk Test (2MWT)<br>* Assess functional walking and aerobic abilities<br>Other: Timed Up & Go Test<br>* measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down<br>Other: Modified Ashworth Scale<br>* score from 0 to 4 evaluation of spasticity<br>Other: Postural Assessment Scale for Stroke<br>* score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position<br>Device: posturographic recording<br>* analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform<br>Other: vibration program<br>* a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. The program will apply a frequency of 100 Hz, with an amplitude of 1 mm<br>|
| Sham Comparator: sham program<br>a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. | Other: Fugl-Meyer Assessment (FMA)<br>* assessment of motor skills : measurement of the intensity of reflexes, as well as an assessment of voluntary movements and motor coordination Score from 0 to 34<br>Other: Medical Research Concil (MRC)<br>* evaluation of muscular strength score from 0 to 5<br>Other: 2 Minute Walk Test (2MWT)<br>* Assess functional walking and aerobic abilities<br>Other: Timed Up & Go Test<br>* measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down<br>Other: Modified Ashworth Scale<br>* score from 0 to 4 evaluation of spasticity<br>Other: Postural Assessment Scale for Stroke<br>* score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position<br>Device: posturographic recording<br>* analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform<br>Other: sham program<br>* a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of Fugl Meyer Assessment (lower limbs) | score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb. | day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score of Fugl Meyer Assessment (lower limbs) | score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb. | day 0, day 15, day 30 and month 2 | 
| score of Medical Research Concil | score of 0 (absence of contraction) to 5 (normal force) | day 0, day 15, day 30 and month 2 | 
| assess functional walking ability | measured with 2 Minute Walk Test | day 0, day 15, day 30 and month 2 | 
| score of postural assessment scale for stroke | measures the patient's ability to maintain stable postures, as well as balance in changes of position score of 0 (cannot perform the activity) to 36 (can perform the activity) | day 0, day 15, day 30 and month 2 | 
| analysis of static equilibrium | with Winposturo platform | day 0, day 15, day 30 and month 2 | 
| positional measurement of the center of gravity | with Winposturo platform | day 0, day 15, day 30 and month 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscle vibration protocol, anterior tibia muscle, hemiplegic patient