An observational study in Stroke, Hemiparesis and Traumatic Brain Injury, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Observational
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.
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)
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 56 is below the median of 152 across 1,968 observational studies indexed under Stroke.
Browse Stroke studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
Counted across the registry records on this site, refreshed daily.
56 patients randomly affected to the experimental group receiving active vibration or sham
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Sequenced muscle vibrations during 30 min., 3 times a week during 5 weeks
Baseline EMG
H-reflex and reciprocal inhibition
Time frame: Evaluation at baseline (4 days before treatment)
Baseline EEG
SEP and resting state activity
Time frame: Evaluation at baseline (4 days before treatment)
EMG change from baseline after 2-week treatment
H-reflex and reciprocal inhibition
Time frame: Evaluation during the 3rd week of treatment
EEG change from baseline after 2-week treatment
SEP and resting state activity
Time frame: Evaluation during the 3rd week of treatment
EMG change after the 5-week treatment
H-reflex and reciprocal inhibition
Time frame: Evaluation 4 days after the end of the 5-week treatment
EEG change after the 5-week treatment
SEP and resting state activity
Time frame: Evaluation 4 days after the end of the 5-week treatment
Baseline MD
Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI
Time frame: 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
Time frame: Evaluation at baseline (4 days before treatment)
Baseline Muscle Strength
score to Medical Research Council scale
Time frame: Evaluation at baseline (4 days before treatment)
Muscle Strength change from baseline after 2-week treatment
score to Medical Research Council scale
Time frame: Evaluation during the 3rd week of treatment
Muscle Strength change from baseline after 5-week treatment
score to Medical Research Council scale
Time frame: Evaluation 4 days after the end of the 5-week treatment
Baseline Spasticity
score to Modified Ashworth scale
Time frame: Evaluation at baseline (4 days before treatment)
Spasticity change from baseline after 2-week treatment
score to Modified Ashworth scale
Time frame: Evaluation during the 3rd week of treatment
Spasticity change from baseline after 5-week treatment
score to Modified Ashworth scale
Time frame: Evaluation 4 days after the end of the 5-week treatment
Baseline sensorimotor function
subscore for lower limbs to Fugl meyer assessment
Time frame: Evaluation at baseline (4 days before treatment)
Sensorimotor function change from baseline after 2-week treatment
subscore for lower limbs to Fugl meyer assessment
Time frame: Evaluation during the 3rd week of treatment
Sensorimotor function change from baseline after 5-week treatment
subscore for lower limbs to Fugl meyer assessment
Time frame: Evaluation 4 days after the end of the 5-week treatment
Baseline Balance
Score to Berg balance scale
Time frame: Evaluation at baseline (4 days before treatment)
Balance change from baseline after 2-week treatment
Score to Berg balance scale
Time frame: Evaluation during the 3rd week of treatment
Balance change from baseline after 5-week treatment
Score to Berg balance scale
Time frame: Evaluation 4 days after the end of the 5-week treatment
Baseline walking
score to 10-m walking test
Time frame: Evaluation at baseline (4 days before treatment)
Walking from baseline after 2-week treatment
score to 10-m walking test
Time frame: Evaluation during the 3rd week of treatment
Walking from baseline after 5-week treatment
score to 10-m walking test
Time frame: 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
Time frame: 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
Time frame: Evaluation 4 days after the end of the 5-week treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Jun 2027, 59 months after the start.
Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's planned 59 months is above that.
Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
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