Neuroplasticity After Proprioceptive Rehabiliation

Study Overview
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Brief Summary
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Sequences of muscle tendon vibrations allow to reproduce the sensory feedback during movement like locomotion and kinaesthesia. It is known that such a treatment promotes motor recovery after stroke assuming that it enhances neuroplasticity. The aim of the research is to study the activity in cerebrospinal circuitry to evaluate the neuroplastic changes during and after instrumented proprioceptive rehabilitation relying on sequences of muscle vibration in subacute stroke stages.

Detailed Description
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Randomized control trial : 28 patients with active vibrations vs. 28 patients with sham stimulation Subacute phase : D15 to 6 months after stroke or patients with traumatic brain injury with similar semiology as stroke (hemiparesis) Measure at baseline : Electrophysiological investigations (EMG,EEG, MRI, clinical evaluation) Treatment of 5 weeks with 3 sessions of vibrations or sham a week Evaluation at mid time (electrophysiology and clinical examinations) Final examination (electrophysiology, MRI and clinical examination)

Official Title
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Neuroplasticity Induced by Functional Muscle Tendon Vibrations in Patients With Acquired Brain Injury

Conditions
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Hemiparesis, Traumatic Brain Injury, Stroke

Intervention / Treatment
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* Device: Vibrations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hemiparesis at least transient in lower limb following an acquired brain injury (stroke or traumatic brain injury) French spoken Affiliated to a French social insurance No previous traumatic, vascular or neurodegenerative injuries Having presented during the acute phase or presenting a motor deficit of one of the lower limbs Presenting an absence of autonomy of walking at the entrance of the rehabilitation department In the sub-acute phase, i.e. from 15 days to 6 months after the accident Presenting moderate cognitive disorders allowing them to understand instructions and give their consent Exclusion Criteria: strong cognitive disorders maintenance of justice, tutelage, legal guardianship Pregnancy and breastfeeding Outpatients who do not have weekly follow-up in the rehabilitation department

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Vibrations|Sequenced muscle vibrations during 30 min., 3 times a week during 5 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline EMG | H-reflex and reciprocal inhibition | Evaluation at baseline (4 days before treatment) | 
| Baseline EEG | SEP and resting state activity | Evaluation at baseline (4 days before treatment) | 
| EMG change from baseline after 2-week treatment | H-reflex and reciprocal inhibition | Evaluation during the 3rd week of treatment | 
| EEG change from baseline after 2-week treatment | SEP and resting state activity | Evaluation during the 3rd week of treatment | 
| EMG change after the 5-week treatment | H-reflex and reciprocal inhibition | Evaluation 4 days after the end of the 5-week treatment | 
| EEG change after the 5-week treatment | SEP and resting state activity | Evaluation 4 days after the end of the 5-week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline MD | Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI | Evaluation at baseline (4 days before treatment) | 
| Baseline FA | Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI | Evaluation at baseline (4 days before treatment) | 
| Baseline Muscle Strength | score to Medical Research Council scale | Evaluation at baseline (4 days before treatment) | 
| Muscle Strength change from baseline after 2-week treatment | score to Medical Research Council scale | Evaluation during the 3rd week of treatment | 
| Muscle Strength change from baseline after 5-week treatment | score to Medical Research Council scale | Evaluation 4 days after the end of the 5-week treatment | 
| Baseline Spasticity | score to Modified Ashworth scale | Evaluation at baseline (4 days before treatment) | 
| Spasticity change from baseline after 2-week treatment | score to Modified Ashworth scale | Evaluation during the 3rd week of treatment | 
| Spasticity change from baseline after 5-week treatment | score to Modified Ashworth scale | Evaluation 4 days after the end of the 5-week treatment | 
| Baseline sensorimotor function | subscore for lower limbs to Fugl meyer assessment | Evaluation at baseline (4 days before treatment) | 
| Sensorimotor function change from baseline after 2-week treatment | subscore for lower limbs to Fugl meyer assessment | Evaluation during the 3rd week of treatment | 
| Sensorimotor function change from baseline after 5-week treatment | subscore for lower limbs to Fugl meyer assessment | Evaluation 4 days after the end of the 5-week treatment | 
| Baseline Balance | Score to Berg balance scale | Evaluation at baseline (4 days before treatment) | 
| Balance change from baseline after 2-week treatment | Score to Berg balance scale | Evaluation during the 3rd week of treatment | 
| Balance change from baseline after 5-week treatment | Score to Berg balance scale | Evaluation 4 days after the end of the 5-week treatment | 
| Baseline walking | score to 10-m walking test | Evaluation at baseline (4 days before treatment) | 
| Walking from baseline after 2-week treatment | score to 10-m walking test | Evaluation during the 3rd week of treatment | 
| Walking from baseline after 5-week treatment | score to 10-m walking test | Evaluation 4 days after the end of the 5-week treatment | 
| Change in MD | Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI | Evaluation 4 days after the end of the 5-week treatment | 
| Change in FA | Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI | Evaluation 4 days after the end of the 5-week treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Neuroplasticity, Electrophysiology, Neurophysiology, Muscle vibration