VibraLCA: Neuroplasticity After Proprioceptive Rehabiliation

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT05277519

Collaborator

(none)

Enrollment

Location

41.5

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Hemiparesis Traumatic Brain Injury	Device: Vibrations

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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

56 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 16, 2022

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Outcome Measures

Primary Outcome Measures

Baseline EMG [Evaluation at baseline (4 days before treatment)]
H-reflex and reciprocal inhibition
Baseline EEG [Evaluation at baseline (4 days before treatment)]
SEP and resting state activity
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
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

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
Baseline Muscle Strength [Evaluation at baseline (4 days before treatment)]
score to Medical Research Council scale
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 2-week treatment [Evaluation during the 3rd week of 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
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
Baseline Balance [Evaluation at baseline (4 days before treatment)]
Score to Berg balance scale
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
Baseline walking [Evaluation at baseline (4 days before treatment)]
score to 10-m walking test
Walking from baseline after 2-week treatment [Evaluation during the 3rd week of treatment]
score to 10-m walking test
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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