Neuroplasticity After Proprioceptive Rehabiliation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorInstitut National de la Santé Et de la Recherche Médicale, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
strong cognitive disorders
maintenance of justice, tutelage, legal guardianship
Pregnancy and breastfeeding
Outpatients who do not have weekly follow-up in the rehabilitation department
Trial population
56 patients randomly affected to the experimental group receiving active vibration or sham
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Vibrations
DeviceSequenced muscle vibrations during 30 min., 3 times a week during 5 weeks
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Baseline EMG
H-reflex and reciprocal inhibition
Time frame
Evaluation at baseline (4 days before treatment)2
Baseline EEG
SEP and resting state activity
Time frame
Evaluation at baseline (4 days before treatment)3
EMG change from baseline after 2-week treatment
H-reflex and reciprocal inhibition
Time frame
Evaluation during the 3rd week of treatment4
EEG change from baseline after 2-week treatment
SEP and resting state activity
Time frame
Evaluation during the 3rd week of treatmentSecondary outcomes
1
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)2
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)3
Baseline Muscle Strength
score to Medical Research Council scale
Time frame
Evaluation at baseline (4 days before treatment)4
Muscle Strength change from baseline after 2-week treatment
score to Medical Research Council scale
Time frame
Evaluation during the 3rd week of treatmentSponsors and contacts
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Source ClinicalTrials.gov