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Recruiting NCT05277519

Neuroplasticity After Proprioceptive Rehabiliation

— Observational Stroke Hemiparesis Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vibrations.
Who it may be relevant to
Registry conditions: Stroke, Hemiparesis, Traumatic Brain Injury. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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)

Interventions

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

Primary outcome measures

  • Baseline EMG [Time frame: Evaluation at baseline (4 days before treatment)]
  • Baseline EEG [Time frame: Evaluation at baseline (4 days before treatment)]
  • EMG change from baseline after 2-week treatment [Time frame: Evaluation during the 3rd week of treatment]
  • EEG change from baseline after 2-week treatment [Time frame: Evaluation during the 3rd week of treatment]
  • EMG change after the 5-week treatment [Time frame: Evaluation 4 days after the end of the 5-week treatment]
  • EEG change after the 5-week treatment [Time frame: Evaluation 4 days after the end of the 5-week treatment]
Secondary outcome measures (12)
  • Baseline MD [Time frame: Evaluation at baseline (4 days before treatment)]
  • Baseline FA [Time frame: Evaluation at baseline (4 days before treatment)]
  • Baseline Muscle Strength [Time frame: Evaluation at baseline (4 days before treatment)]
  • Muscle Strength change from baseline after 2-week treatment [Time frame: Evaluation during the 3rd week of treatment]
  • Muscle Strength change from baseline after 5-week treatment [Time frame: Evaluation 4 days after the end of the 5-week treatment]
  • Baseline Spasticity [Time frame: Evaluation at baseline (4 days before treatment)]
  • Spasticity change from baseline after 2-week treatment [Time frame: Evaluation during the 3rd week of treatment]
  • Spasticity change from baseline after 5-week treatment [Time frame: Evaluation 4 days after the end of the 5-week treatment]
  • Baseline sensorimotor function [Time frame: Evaluation at baseline (4 days before treatment)]
  • Sensorimotor function change from baseline after 2-week treatment [Time frame: Evaluation during the 3rd week of treatment]
  • Sensorimotor function change from baseline after 5-week treatment [Time frame: Evaluation 4 days after the end of the 5-week treatment]
  • Baseline Balance [Time frame: Evaluation at baseline (4 days before treatment)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Pitié-Salpêtrière Hospital — Paris

Identifiers

NCT: NCT05277519 · C20-11 · 2021-A00822-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗