Neuroplasticity After Proprioceptive Rehabiliation (VibraLCA)

Institut National de la Santé Et de la Recherche Médicale, France

Status: Enrolling

Conditions: Traumatic Brain Injury; Stroke; Hemiparesis

Treatments: Device: Vibrations

Study type: Observational

Funder types: Other

Identifiers

NCT05277519

C20-11

2021-A00822-39 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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