Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05277519

Neuroplasticity After Proprioceptive Rehabiliation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stroke Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrations

Device

Sequenced muscle vibrations during 30 min., 3 times a week during 5 weeks

Primary outcomes

  1. Baseline EMG

    Time frame: Evaluation at baseline (4 days before treatment)

    H-reflex and reciprocal inhibition

  2. Baseline EEG

    Time frame: Evaluation at baseline (4 days before treatment)

    SEP and resting state activity

  3. EMG change from baseline after 2-week treatment

    Time frame: Evaluation during the 3rd week of treatment

    H-reflex and reciprocal inhibition

  4. EEG change from baseline after 2-week treatment

    Time frame: Evaluation during the 3rd week of treatment

    SEP and resting state activity

  5. EMG change after the 5-week treatment

    Time frame: Evaluation 4 days after the end of the 5-week treatment

    H-reflex and reciprocal inhibition

  6. EEG change after the 5-week treatment

    Time frame: Evaluation 4 days after the end of the 5-week treatment

    SEP and resting state activity

Secondary outcomes

  1. Baseline MD

    Time frame: 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

  2. Baseline FA

    Time frame: 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

  3. Baseline Muscle Strength

    Time frame: Evaluation at baseline (4 days before treatment)

    score to Medical Research Council scale

  4. Muscle Strength change from baseline after 2-week treatment

    Time frame: Evaluation during the 3rd week of treatment

    score to Medical Research Council scale

  5. Muscle Strength change from baseline after 5-week treatment

    Time frame: Evaluation 4 days after the end of the 5-week treatment

    score to Medical Research Council scale

  6. Baseline Spasticity

    Time frame: Evaluation at baseline (4 days before treatment)

    score to Modified Ashworth scale

  7. Spasticity change from baseline after 2-week treatment

    Time frame: Evaluation during the 3rd week of treatment

    score to Modified Ashworth scale

  8. Spasticity change from baseline after 5-week treatment

    Time frame: Evaluation 4 days after the end of the 5-week treatment

    score to Modified Ashworth scale

  9. Baseline sensorimotor function

    Time frame: Evaluation at baseline (4 days before treatment)

    subscore for lower limbs to Fugl meyer assessment

  10. Sensorimotor function change from baseline after 2-week treatment

    Time frame: Evaluation during the 3rd week of treatment

    subscore for lower limbs to Fugl meyer assessment

  11. Sensorimotor function change from baseline after 5-week treatment

    Time frame: Evaluation 4 days after the end of the 5-week treatment

    subscore for lower limbs to Fugl meyer assessment

  12. Baseline Balance

    Time frame: Evaluation at baseline (4 days before treatment)

    Score to Berg balance scale

  13. Balance change from baseline after 2-week treatment

    Time frame: Evaluation during the 3rd week of treatment

    Score to Berg balance scale

  14. Balance change from baseline after 5-week treatment

    Time frame: Evaluation 4 days after the end of the 5-week treatment

    Score to Berg balance scale

  15. Baseline walking

    Time frame: Evaluation at baseline (4 days before treatment)

    score to 10-m walking test

  16. Walking from baseline after 2-week treatment

    Time frame: Evaluation during the 3rd week of treatment

    score to 10-m walking test

  17. Walking from baseline after 5-week treatment

    Time frame: Evaluation 4 days after the end of the 5-week treatment

    score to 10-m walking test

  18. Change in MD

    Time frame: 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

  19. Change in FA

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Eleonore Bayen, MD, PhD

CONTACT

[email protected]

+33142161120

Veronique Marchand-Pauvert, PhD

CONTACT

[email protected]

+33142161120

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

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

Acronym: VibraLCA

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 14, 2022
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.