Clinical trial NCT05277519: Neuroplasticity After Proprioceptive Rehabiliation
Official title: Neuroplasticity Induced by Functional Muscle Tendon Vibrations in Patients With Acquired Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Hemiparesis
Traumatic Brain Injury
Keywords: Neuroplasticity
Electrophysiology
MRI
Neurophysiology
Muscle vibration
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2022-03-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 56 patients randomly affected to the experimental group receiving active vibration or sham

Brief summary: 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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Baseline EMG
timeFrame: Evaluation at baseline (4 days before treatment)
measure: Baseline EEG
timeFrame: Evaluation at baseline (4 days before treatment)
measure: EMG change from baseline after 2-week treatment
timeFrame: Evaluation during the 3rd week of treatment
measure: EEG change from baseline after 2-week treatment
timeFrame: Evaluation during the 3rd week of treatment
measure: EMG change after the 5-week treatment
timeFrame: Evaluation 4 days after the end of the 5-week treatment
measure: EEG change after the 5-week treatment
timeFrame: Evaluation 4 days after the end of the 5-week treatment
Secondary outcomes:
measure: Baseline MD
timeFrame: Evaluation at baseline (4 days before treatment)
measure: Baseline FA
timeFrame: Evaluation at baseline (4 days before treatment)
measure: Baseline Muscle Strength
timeFrame: Evaluation at baseline (4 days before treatment)
measure: Muscle Strength change from baseline after 2-week treatment
timeFrame: Evaluation during the 3rd week of treatment
measure: Muscle Strength change from baseline after 5-week treatment
timeFrame: Evaluation 4 days after the end of the 5-week treatment
measure: Baseline Spasticity
timeFrame: Evaluation at baseline (4 days before treatment)
measure: Spasticity change from baseline after 2-week treatment
timeFrame: Evaluation during the 3rd week of treatment
measure: Spasticity change from baseline after 5-week treatment
timeFrame: Evaluation 4 days after the end of the 5-week treatment
measure: Baseline sensorimotor function
timeFrame: Evaluation at baseline (4 days before treatment)
measure: Sensorimotor function change from baseline after 2-week treatment
timeFrame: Evaluation during the 3rd week of treatment
measure: Sensorimotor function change from baseline after 5-week treatment
timeFrame: Evaluation 4 days after the end of the 5-week treatment
measure: Baseline Balance
timeFrame: Evaluation at baseline (4 days before treatment)
measure: Balance change from baseline after 2-week treatment
timeFrame: Evaluation during the 3rd week of treatment
measure: Balance change from baseline after 5-week treatment
timeFrame: Evaluation 4 days after the end of the 5-week treatment
measure: Baseline walking
timeFrame: Evaluation at baseline (4 days before treatment)
measure: Walking from baseline after 2-week treatment
timeFrame: Evaluation during the 3rd week of treatment
measure: Walking from baseline after 5-week treatment
timeFrame: Evaluation 4 days after the end of the 5-week treatment
measure: Change in MD
timeFrame: Evaluation 4 days after the end of the 5-week treatment
measure: Change in FA
timeFrame: Evaluation 4 days after the end of the 5-week treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié-Salpêtrière Hospital
Study officials:
affiliation: Sorbonne University - AP-HP (Pitié-Salpêtrière Hospital)
name: Eleonore Bayen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: