The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population

Study Overview
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Brief Summary
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Several studies have recently tested the use of muscle vibration for the rehabilitation of patients after a stroke. When applied in a repeated and focused manner, this vibration appears to promote the recovery of functional capacities through the mechanisms of neuromuscular plasticity. These results are encouraging, showing in particular a significant decrease in spasticity in post-stroke patients in the chronic phase (> 6 months after stroke), on the upper and/or lower limbs. However, very few studies have been done on this type of early intervention. Muscle vibration may therefore be an innovative therapy to complement the care that is currently offered in the acute and subacute phase of post-stroke rehabilitation. Moreover, brain plasticity after a stroke is particularly high in the 3 months after the accident, but the vast majority of studies having evaluated the impact of vibration in a chronic phase (> 12 months post-stroke). It is likely, however, that the influence of vibration, particularly on brain plasticity, is increased in the acute or subacute phase (first 6 months). To date, the effect of vibration on spinal cord or cortical plasticity has not been quantified in the acute or subacute phase. This is why the second part of this project (phase 2) aims to systematically evaluate and quantify the neuroplastic and functional effects of post-stroke vibration in the early phase. Phase 1 - Validation of a method for measuring spasticity (upper limb) with an isokinetic dynamometer 32 patients with ischemic and/or hemorrhagic stroke (> 3 months after stroke) Phase 2 - Use of this objective technique to measure the effect of a muscle vibration protocol to limit the onset of spasticity in a population of 100 patients following a stroke, in the acute or subacute phase (< 6 weeks post-stroke) in a randomized trial: intervention group: usual rehabilitation + muscle vibrations control group: usual rehabilitation + placebo vibrations

Official Title
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The Effects of Muscle Vibration on the Development of Spasticity and Neuroplasticity in a Post-stroke Population (Acute and Subacute Phases): Randomized Controlled Trial

Conditions
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Post-stroke Patient in Acute, Sub-acute Phase or Chronic

Intervention / Treatment
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* Other: Dynamometer
* Other: Muscle vibrations
* Other: Muscle vibrations
* Other: Placebo muscle vibration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Phase 1: Adult patient, Medically stable on medical assessment, with no contraindications to stroke rehabilitation management management (no medical problems or acute intercurrent medical events), Have had an ischemic and/or hemorrhagic stroke (> 3 months post-stroke), impacting the motor skills of the upper limbs, 1 ≤ MAS < 4 on elbow or wrist flexors, Having given oral consent. Phase 2: Adult patient, Medically stable on medical evaluation, with no contraindications to stroke rehabilitation (no medical issues or acute intercurrent medical events), With a first stroke < 6 weeks previously, confirmed by imaging, Altered motor skills in the upper limb (contralateral to the lesion) (Fugl and Meyer score), particularly in the wrist and elbow flexors, Requiring inpatient or outpatient hospitalization in a rehabilitation center, Having given oral consent. Exclusion Criteria: Phases 1 and 2: Significant pain on mobilization of the elbow or wrist (visual analog scale > 5/10), Presence of other neurological, muscular or osteoarticular conditions altering the functioning of the upper limb, Apparent wound, which may defer inclusion, or very fragile skin, Significant cognitive impairment: inability to understand simple instructions or give consent of any kind (not included if: LAST scores < 5/7 in comprehension, and if YES/NO answers are unreliable), Not covered by national health insurance, Pregnant or breastfeeding, Being under guardianship or curatorship. Person subject to a measure of legal protection

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 1<br> | Other: Dynamometer<br>* Measurement of elbow/wrist spasticity<br>Other: Muscle vibrations<br>* 1 session of 10 minutes<br>|
| Experimental: Phase 2: Intervention group<br> | Other: Muscle vibrations<br>* 3 times/week for 6 weeks<br>|
| Active Comparator: Phase 2: control group<br> | Other: Placebo muscle vibration<br>* 3 times/week for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Joint angle (elbow or wrist of the limb contralateral to the brain injury) | Joint angle (elbow or wrist of the limb contralateral to the brain injury) at the onset of a spastic contraction (maximum intensity of resistance to mobilization) recorded by isokinetic dynamometer on a wheelchair during the initial visit | at baseline | 
| Phase 2: Scoring wrist flexor muscle spasticity | Scoring of wrist flexor muscle spasticity by the Modified Ashworth Scale (MAS), at the beginning of the study and at 6 weeks (end of intervention). | at 6 weeks |