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Neuroplasticity After Proprioceptive Rehabiliation

NCT ID: NCT05277519

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-16

Study Completion Date

2026-11-30

Brief Summary

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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

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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)

Conditions

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Stroke Hemiparesis Traumatic Brain Injury

Keywords

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Neuroplasticity Electrophysiology MRI Neurophysiology Muscle vibration

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Vibrations

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eleonore Bayen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Pitié-Salpêtrière Hospital

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Veronique Marchand-Pauvert, PhD

Role: CONTACT

Phone: +33142161120

Email: [email protected]

Eleonore Bayen, MD, PhD

Role: CONTACT

Phone: +33142161120

Email: [email protected]

Facility Contacts

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Eleonore Bayen, MD, PhD

Role: primary

Veronique Marchand-Pauvert, PhD

Role: backup

Other Identifiers

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2021-A00822-39

Identifier Type: REGISTRY

Identifier Source: secondary_id

C20-11

Identifier Type: -

Identifier Source: org_study_id