Идёт набор NCT05277519

Neuroplasticity After Proprioceptive Rehabiliation

— Наблюдательное Stroke Hemiparesis Traumatic Brain Injury

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Vibrations.
Кому может быть актуально: Состояния в реестре: Stroke, Hemiparesis, Traumatic Brain Injury. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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)

Вмешательства

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

Первичные конечные точки

Baseline EMG [Срок оценки: Evaluation at baseline (4 days before treatment)]
Baseline EEG [Срок оценки: Evaluation at baseline (4 days before treatment)]
EMG change from baseline after 2-week treatment [Срок оценки: Evaluation during the 3rd week of treatment]
EEG change from baseline after 2-week treatment [Срок оценки: Evaluation during the 3rd week of treatment]
EMG change after the 5-week treatment [Срок оценки: Evaluation 4 days after the end of the 5-week treatment]
EEG change after the 5-week treatment [Срок оценки: Evaluation 4 days after the end of the 5-week treatment]

Вторичные конечные точки (12)

Baseline MD [Срок оценки: Evaluation at baseline (4 days before treatment)]
Baseline FA [Срок оценки: Evaluation at baseline (4 days before treatment)]
Baseline Muscle Strength [Срок оценки: Evaluation at baseline (4 days before treatment)]
Muscle Strength change from baseline after 2-week treatment [Срок оценки: Evaluation during the 3rd week of treatment]
Muscle Strength change from baseline after 5-week treatment [Срок оценки: Evaluation 4 days after the end of the 5-week treatment]
Baseline Spasticity [Срок оценки: Evaluation at baseline (4 days before treatment)]
Spasticity change from baseline after 2-week treatment [Срок оценки: Evaluation during the 3rd week of treatment]
Spasticity change from baseline after 5-week treatment [Срок оценки: Evaluation 4 days after the end of the 5-week treatment]
Baseline sensorimotor function [Срок оценки: Evaluation at baseline (4 days before treatment)]
Sensorimotor function change from baseline after 2-week treatment [Срок оценки: Evaluation during the 3rd week of treatment]
Sensorimotor function change from baseline after 5-week treatment [Срок оценки: Evaluation 4 days after the end of the 5-week treatment]
Baseline Balance [Срок оценки: Evaluation at baseline (4 days before treatment)]

Критерии участия

Критерии включения

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