ExoDoF: роботизированный экзоскелет для двигательной реабилитации верхних конечностей после инсульта
Two decades ago, the projection of recovery of the upper extremity (UE) after a stroke had a very poor prognosis worldwide. Nowadays, thanks to medical advances and early rehabilitation, the prognosis for recovery has improved; however, there is still a limit that no therapy has been able to overcome, related to spontaneous recovery as part of the natural evolution of the pathophysiological process, rather than with the contribution of rehabilitation. Additionally, existing therapies show partial effectiveness on the recovery of UE function, but do not avoid the use of compensatory strategies or alternatives to normal movement. Given this situation, there is an active search for new therapeutic approaches. In this clinical trial the investigators propose a rehabilitation paradigm that promotes the recovery of control of specific planes of movement through the selective restriction of degrees of freedom, simplifying control demands. The investigators sought to test the hypothesis that people with stroke in the early subacute stage and who present alterations in the movement of the upper extremity, a rehabilitation protocol that reduces the degrees of freedom of the UE and trunk, enables greater recovery of the movement of the UE and less use of compensatory movements compared to a protocol without DoF control. The general objective is to demonstrate the effect of training with restriction of the degrees of freedom of UE and trunk, mediated by an exoskeleton and videogames, on the control of the UE.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Pablo Burgos, PhD
- Номер телефона: 19713314101
- Электронная почта: pburgos@uchile.cl
Учебное резервное копирование контактов
- Имя: Juan José Mariman, PhD
- Номер телефона: +56981928168
- Электронная почта: juan.mariman@umce.cl
Места учебы
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Santiago, Чили
- Рекрутинг
- Hospital El Carmen
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Контакт:
- Daniel Bustos, PT
- Номер телефона: +56 9 7754 9193
- Электронная почта: daniel.bustos.c@usach.cl
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Santiago, Чили
- Рекрутинг
- Hospital Clínico Universidad de Chile
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Контакт:
- Hachi Manzur, Ph.D
- Номер телефона: +56 9 8192 8168
- Электронная почта: hemanzur@gmail.com
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Santiago, Чили
- Рекрутинг
- Hospital San José
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Контакт:
- Natalia Gonzalez, PT
- Номер телефона: +56 9 8154 8009
- Электронная почта: nataliagonzaleznunes@gmail.com
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Temuco, Чили
- Рекрутинг
- Hospital Dr. Hernán Henríquez Aravena
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Контакт:
- Pablo Hernández, PT
- Номер телефона: +56 9 7853 9892
- Электронная почта: klgo.pablohernandez@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Diagnosis of ischemic or hemorrhagic stroke with zero to twelve weeks of evolution.
- Subjects with alterations in active voluntary movement of ES with Fugl Meyer less than or equal to 50 points. Strength of shoulder abduction and finger extension from palpable contraction (1 in Medical Research Council (MRC) scale for muscle strength).
Exclusion Criteria:
- Cognitive impairment that prevents signing the informed consent, following the instructions and understanding the procedures. (MOCA < 18).
- Inability to perform activities sitting for more than 90 minutes or inability to perform activities without severe pain (VAS > 6) or having limited reach ranges.
- Have severe visual impairment that does not allow to carry out the activities associated with the task.
- Previous stroke with neurological sequelae in the upper extremity.
- Present bilateral sensorimotor alterations.
- Damage to the cerebellum/peduncles described in the radiological report or classic signs of cerebellar damage (Upper extremity SARA items of 2 or more)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: DoF Group
The experimental group with control of the degrees of freedom will receive treatment for 4 weeks using an exoskeleton and also it will be supervised by a physiotherapist.The exoskeleton will restrict the movement of the trunk and upper extremity to leave only the joint free to work in the plane of interest. The training will be selective in an articular plane with biofeedback of movement through videogames and external movement sensors installed in the upper extremity. This movement sensor will allow to interact with the videogames through the movement of the trained movement. |
Training of specific uniarticular and single plane movement of the upper limb through an exoskeleton and videogames that will be supervised by a physiotherapist. |
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Активный компаратор: Task Group
The group without control of the degrees of freedom (Task Group) will receive a therapeutic intervention equivalent in dose, but without any restriction of joint movement (without the exoskeleton). Each session will be divided into two parts. In the first part, participants will train with combined planes and in a multi-joint manner with the same video games as DoF Group but with the movement sensor in your hand performing 4 direction movements with the upper limb (horizontal, vertical and diagonals). In the second training part, patients will perform functional tasks: raise and lower your hand on the table, cleaning a table, put cream on the non-paretic arm, hold a bottle, put a piece of bread or something similar in your mouth, wash your face, brush your hair, store items in a basket, brush teeth, wrote and serve water in glass. |
Training of multiarticular upper limb movements (vertical, horizontal and diagonal) through videogames and also training of functional task (raise and lower your hand on the table, cleaning a table, put cream on the non-paretic arm, hold a bottle, put a piece of bread or something similar in your mouth, wash your face, brush your hair, store items in a basket, brush teeth, wrote and serve water in glass). This activities will be supervised by a physiotherapist. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in UE-FMA at the end of the training
Временное ограничение: 3 days post training
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Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at the end of the training |
3 days post training
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Change in UE-FMA at 6 months post stroke
Временное ограничение: 180 days post stroke
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Differences between the Upper Extremity Fugl-Meyer Assessment (UE-FMA) at the beginning of the recruitment and at 6 months post stroke |
180 days post stroke
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in ARAT at the end of the training
Временное ограничение: 3 days post training
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Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at the end of the training |
3 days post training
|
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Change in ARAT at 6 months post stroke
Временное ограничение: 180 days post stroke
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Differences between the Action Research Arm Test (ARAT) at the beginning of the recruitment and at 6 months post stroke |
180 days post stroke
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Change in iCoh at the end of the training
Временное ограничение: 3 days post training
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Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at the end of the training |
3 days post training
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Change in iCoh connectivity at 6 months post stroke
Временное ограничение: 180 days post stroke
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Differences between EEG Ipsi-Contralateral Motor Cortex connectivity (iCoh) at the beginning of the training and at 6 months post stroke |
180 days post stroke
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Change in arm kinematics at the end of the training
Временное ограничение: 3 days post training
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Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at the end of the training |
3 days post training
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Change in arm kinematics at 6 months post stroke
Временное ограничение: 180 days post stroke
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Differences between arm kinematics (shoulder, elbow, wrist and finger angles during reaching and grasping a glass) at the beginning of the training and at 6 months post stroke |
180 days post stroke
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Pablo Burgos, PhD, University of Chile
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- FONDEF IDeA 2023 ID23I104
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
all collected IPD
Сроки обмена IPD
After the publication of the clinical trial, for 5 years.
Критерии совместного доступа к IPD
Based on reasonable request to the project director (Pablo Burgos, pburgos@uchile.cl), the data will be shared.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .