Меню
Идёт набор NCT07254195

Assessment of an Intensive Motor Telerehabilitation Program for Stroke Patients

Без фазы С лечением Stroke

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: Telerehabilitation program using the MindMotion GO device.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: 18 лет — 85 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 →
Официальное название

Intensive Motor Rehabilitation of Stroke Patients: Evaluation of a Telerehabilitation Program

Обзор

Stroke is a major cause of motor disability, particularly hemiplegia, and its incidence is increasing as the population ages. Despite partial spontaneous recovery in the first three months, 80% of patients retain a motor deficit after six months, requiring intensive rehabilitation to maximize recovery. However, after hospitalization, access to intensive rehabilitation is limited, due to geographical and mobility constraints, and the lack of reimbursement for private occupational therapy. Telerehabilitation, using digital technologies, can overcome these difficulties by offering interactive, accessible rehabilitation at home. Studies show that its effectiveness is comparable to that of clinical rehabilitation. Our study therefore proposes to evaluate the feasibility and effects of a home-based telerehabilitation program using the MindMotion GO device (MindMaze). This 12-week program aims to provide an additional intensive dose of rehabilitation to the standard of care, with 300 minutes of weekly active therapy, planned and monitored remotely by a therapist.

Подробное описание

Stroke is a major cause of motor disability, particularly hemiplegia, and its incidence is increasing as the population ages. Despite partial spontaneous recovery in the first three months, 80% of patients retain a motor deficit after six months, requiring intensive rehabilitation to maximize recovery. However, after hospitalization, access to intensive rehabilitation is limited, due to geographical and mobility constraints, and the lack of reimbursement for private occupational therapy.

Telerehabilitation, using digital technologies, can overcome these difficulties by offering interactive, accessible rehabilitation at home. Studies show that its effectiveness is comparable to that of clinical rehabilitation.

Our study therefore proposes to evaluate the feasibility and effects of a home-based telerehabilitation program using the MindMotion GO device (MindMaze). This 12-week program aims to provide an additional intensive dose of rehabilitation to the standard of care, with 300 minutes of weekly active therapy, planned and monitored remotely by a therapist. It combines synchronous (1time a week with a therapist) and asynchronous (autonomous) sessions.

This program is integrated into the post-stroke care pathway by facilitating the transition from hospital to home, without prolonging hospitalization or increasing face-to-face sessions.

The study will be a single-center randomized controlled trial, targeting patients in the sub-acute and chronic stages of stroke.

Вмешательства

  • Устройство Telerehabilitation program using the MindMotion GO device
    In parallel to the standard of care, patients will participate in a 12-weeks telerehabilitation program using the MindMotion GO device. MindMotion GO is a digital therapy device that offers a catalog of interactive games designed specifically for patients with neurological injuries. During the telerehabilitation program, patients will aim to achieve at least 300 minutes of active therapy per week. They will have 1 synchronous session per week in the clinic or remotely by videoconference with a

Первичные конечные точки

  • Variation in the Goal Attainment Scale (GAS) score. [Срок оценки: Baseline, at 8, 20, 32 and 44 weeks]

Критерии участия

Критерии включения

  • Hospitalized for a first ischemic or hemorrhagic stroke
  • Stroke occurrence more than 30 days prior
  • Presenting motor deficits affecting the upper limb, with or without involvement of the lower limb
  • Able to follow the instructions of the home program using the MindMotion GO device
  • Having at home an accessible email address, an Internet connection with password, a smartphone, a screen or TV with HDMI input (Full HD 1080p resolution), and a free space of approximately 1 m x 2.5 m in front of the screen
  • Ability to sit without assistance
  • Patient agreeing to participate in the study by signing an informed consent form
  • Affiliated with, or entitled to, a social security scheme

Критерии исключения

History of stroke

  • Neurological pathology other than stroke
  • Patient with uncontrolled epilepsy or seizure disorder
  • Cardiac disease limiting exercise
  • Pain limiting rehabilitation dose
  • Major comprehension problems or severe psychiatric and/or cognitive disorders that could compromise understanding of the protocol and the smooth running of the study.
  • Uncorrected hearing or visual deficits
  • Severe apraxia
  • Severe memory impairment
  • Severe unilateral spatial neglect
  • Total plegia of affected limb
  • Pregnant, parturient or breast-feeding women
  • Persons deprived of their liberty by judicial or administrative decision
  • Persons admitted to a health or social institution for purposes other than research
  • Adults under legal protection (guardianship, curatorship)
  • Subjects participating in other intervention research.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 1 центр
  • Hopital Henry Gabrielle — Saint-Genis-Laval

Идентификаторы

NCT: NCT07254195 · 69HCL24_0504 · 2025-A01054-45

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗