Neuroplasticity After Proprioceptive Rehabiliation
- Conditions
- Traumatic Brain InjuryStrokeHemiparesis
- Registration Number
- NCT05277519
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
- 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
- strong cognitive disorders
- maintenance of justice, tutelage, legal guardianship
- Pregnancy and breastfeeding
- Outpatients who do not have weekly follow-up in the rehabilitation department
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Baseline EMG Evaluation at baseline (4 days before treatment) H-reflex and reciprocal inhibition
EMG change from baseline after 2-week treatment Evaluation during the 3rd week of treatment H-reflex and reciprocal inhibition
EEG change from baseline after 2-week treatment Evaluation during the 3rd week of treatment SEP and resting state activity
EMG change after the 5-week treatment Evaluation 4 days after the end of the 5-week treatment H-reflex and reciprocal inhibition
Baseline EEG Evaluation at baseline (4 days before treatment) SEP and resting state activity
EEG change after the 5-week treatment Evaluation 4 days after the end of the 5-week treatment SEP and resting state activity
- Secondary Outcome Measures
Name Time Method Baseline Muscle Strength Evaluation at baseline (4 days before treatment) score to Medical Research Council scale
Walking from baseline after 5-week treatment Evaluation 4 days after the end of the 5-week treatment score to 10-m walking test
Change in MD Evaluation 4 days after the end of the 5-week treatment Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI
Sensorimotor function change from baseline after 5-week treatment Evaluation 4 days after the end of the 5-week treatment subscore for lower limbs to Fugl meyer assessment
Spasticity change from baseline after 2-week treatment Evaluation during the 3rd week of treatment score to Modified Ashworth scale
Baseline Balance Evaluation at baseline (4 days before treatment) Score to Berg balance scale
Baseline walking Evaluation at baseline (4 days before treatment) score to 10-m walking test
Change in FA Evaluation 4 days after the end of the 5-week treatment Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI
Baseline MD Evaluation at baseline (4 days before treatment) Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI
Baseline FA Evaluation at baseline (4 days before treatment) Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI
Muscle Strength change from baseline after 2-week treatment Evaluation during the 3rd week of treatment score to Medical Research Council scale
Muscle Strength change from baseline after 5-week treatment Evaluation 4 days after the end of the 5-week treatment score to Medical Research Council scale
Baseline Spasticity Evaluation at baseline (4 days before treatment) score to Modified Ashworth scale
Spasticity change from baseline after 5-week treatment Evaluation 4 days after the end of the 5-week treatment score to Modified Ashworth scale
Baseline sensorimotor function Evaluation at baseline (4 days before treatment) subscore for lower limbs to Fugl meyer assessment
Sensorimotor function change from baseline after 2-week treatment Evaluation during the 3rd week of treatment subscore for lower limbs to Fugl meyer assessment
Balance change from baseline after 2-week treatment Evaluation during the 3rd week of treatment Score to Berg balance scale
Balance change from baseline after 5-week treatment Evaluation 4 days after the end of the 5-week treatment Score to Berg balance scale
Walking from baseline after 2-week treatment Evaluation during the 3rd week of treatment score to 10-m walking test
Trial Locations
- Locations (1)
Pitié-Salpêtrière Hospital
🇫🇷Paris, France