Neuroplasticity After Proprioceptive Rehabiliation

NCT05277519 | Recruiting

• 2 other identifiers: C20-112021-A00822-39
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis; Traumatic Brain Injury

Keywords

Neuroplasticity; Electrophysiology; MRI; Neurophysiology; Muscle vibration

Outcome Measures

Primary Outcomes (6)

• Baseline EMG

  H-reflex and reciprocal inhibition

  Evaluation at baseline (4 days before treatment)

• Baseline EEG

  SEP and resting state activity

  Evaluation at baseline (4 days before treatment)

• EMG change from baseline after 2-week treatment

  H-reflex and reciprocal inhibition

  Evaluation during the 3rd week of treatment

• EEG change from baseline after 2-week treatment

  SEP and resting state activity

  Evaluation during the 3rd week of treatment

• EMG change after the 5-week treatment

  H-reflex and reciprocal inhibition

  Evaluation 4 days after the end of the 5-week treatment

• EEG change after the 5-week treatment

  SEP and resting state activity

  Evaluation 4 days after the end of the 5-week treatment

Secondary Outcomes (19)

• Baseline MD

  Evaluation at baseline (4 days before treatment)

• Baseline FA

  Evaluation at baseline (4 days before treatment)

• Baseline Muscle Strength

  Evaluation at baseline (4 days before treatment)

• Muscle Strength change from baseline after 2-week treatment

  Evaluation during the 3rd week of treatment

• Muscle Strength change from baseline after 5-week treatment

  Evaluation 4 days after the end of the 5-week treatment

Interventions

Vibrations DEVICE

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

56 patients randomly affected to the experimental group receiving active vibration or sham

You may qualify if:

• 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

You may not qualify if:

• strong cognitive disorders
• maintenance of justice, tutelage, legal guardianship
• Pregnancy and breastfeeding
• Outpatients who do not have weekly follow-up in the rehabilitation department

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Eleonore Bayen, MD, PhD

  Sorbonne University - AP-HP (Pitié-Salpêtrière Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronique Marchand-Pauvert, PhD

CONTACT

+33142161120; veronique.marchand-pauvert@inserm.fr

Eleonore Bayen, MD, PhD

CONTACT

+33142161120; eleonor.bayen@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: March 14, 2022
• Study Start: June 16, 2022
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

FR (1)