Neuroplasticity After Proprioceptive Rehabiliation

Stroke Clinical Trial

— VibraLCA  

Official title:

Neuroplasticity Induced by Functional Muscle Tendon Vibrations in Patients With Acquired Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277519
• Other study ID #: C20-11
• Secondary ID: 2021-A00822-39
• Status: Recruiting
• Start date: June 16, 2022
• Est. completion date: November 30, 2026

Study information

• Verified date: September 2023
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Veronique Marchand-Pauvert, PhD
• Phone: +33142161120
• Email: veronique.marchand-pauvert[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: November 30, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Hemiparesis
• Paresis
• Stroke
• Traumatic Brain Injury

Intervention

Device:
• Vibrations
Sequenced muscle vibrations during 30 min., 3 times a week during 5 weeks

Locations

Country	Name	City	State
France	Pitié-Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline EMG	H-reflex and reciprocal inhibition	Evaluation at baseline (4 days before treatment)
Primary	Baseline EEG	SEP and resting state activity	Evaluation at baseline (4 days before treatment)
Primary	EMG change from baseline after 2-week treatment	H-reflex and reciprocal inhibition	Evaluation during the 3rd week of treatment
Primary	EEG change from baseline after 2-week treatment	SEP and resting state activity	Evaluation during the 3rd week of treatment
Primary	EMG change after the 5-week treatment	H-reflex and reciprocal inhibition	Evaluation 4 days after the end of the 5-week treatment
Primary	EEG change after the 5-week treatment	SEP and resting state activity	Evaluation 4 days after the end of the 5-week treatment
Secondary	Baseline MD	Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI	Evaluation at baseline (4 days before treatment)
Secondary	Baseline FA	Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI	Evaluation at baseline (4 days before treatment)
Secondary	Baseline Muscle Strength	score to Medical Research Council scale	Evaluation at baseline (4 days before treatment)
Secondary	Muscle Strength change from baseline after 2-week treatment	score to Medical Research Council scale	Evaluation during the 3rd week of treatment
Secondary	Muscle Strength change from baseline after 5-week treatment	score to Medical Research Council scale	Evaluation 4 days after the end of the 5-week treatment
Secondary	Baseline Spasticity	score to Modified Ashworth scale	Evaluation at baseline (4 days before treatment)
Secondary	Spasticity change from baseline after 2-week treatment	score to Modified Ashworth scale	Evaluation during the 3rd week of treatment
Secondary	Spasticity change from baseline after 5-week treatment	score to Modified Ashworth scale	Evaluation 4 days after the end of the 5-week treatment
Secondary	Baseline sensorimotor function	subscore for lower limbs to Fugl meyer assessment	Evaluation at baseline (4 days before treatment)
Secondary	Sensorimotor function change from baseline after 2-week treatment	subscore for lower limbs to Fugl meyer assessment	Evaluation during the 3rd week of treatment
Secondary	Sensorimotor function change from baseline after 5-week treatment	subscore for lower limbs to Fugl meyer assessment	Evaluation 4 days after the end of the 5-week treatment
Secondary	Baseline Balance	Score to Berg balance scale	Evaluation at baseline (4 days before treatment)
Secondary	Balance change from baseline after 2-week treatment	Score to Berg balance scale	Evaluation during the 3rd week of treatment
Secondary	Balance change from baseline after 5-week treatment	Score to Berg balance scale	Evaluation 4 days after the end of the 5-week treatment
Secondary	Baseline walking	score to 10-m walking test	Evaluation at baseline (4 days before treatment)
Secondary	Walking from baseline after 2-week treatment	score to 10-m walking test	Evaluation during the 3rd week of treatment
Secondary	Walking from baseline after 5-week treatment	score to 10-m walking test	Evaluation 4 days after the end of the 5-week treatment
Secondary	Change in MD	Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI	Evaluation 4 days after the end of the 5-week treatment
Secondary	Change in FA	Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI	Evaluation 4 days after the end of the 5-week treatment