Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
17 мая 2017 г. обновлено: Chang Gung Memorial Hospital
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program
The purpose of this study was to compare the treatment effects of home-based or clinic-based bilateral training with and without mirror feedback programon on physiological markers, sensorimotor, cognition, daily functions, and participation among patients with chronic stroke.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
24
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Kaohsiung County, Тайвань
- Chang Gung Memorial Hospital
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Taoyuan County, Тайвань
- Chang Gung Memorial Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 20 лет до 80 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- The most recent stroke was between 1 month and 5 years
- No serious cognitive impairment (MMSE≥21)
- FMA score =18-62
- No serious muscle spasticity in shoulder, elbow, wrist and finger (MAS≤3)
- Modified rankin Scale=2 to 4
Exclusion Criteria:
- Aphasia that might interfere with understanding instructions
- Stroke in areas other than the brain and brainstem, such as the cerebellum
- other neurological disease, such as dementia
- Muscle and joint have serious pain and inflammatory swelling in affected side.
- Cannot control hypertension, heart disease and serious throbosis
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Home-based
Participants in home-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the home-based training, a four-week wash-out period followed. Then, patients will receive the clinic-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. |
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Активный компаратор: Clinic-based
Participants in clinic-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the clinic-based training, a four-week wash-out period followed. Then, patients will receive the home-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Fugl-Myer Assessment, FMA
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Mini-Mental State Exam, MMSE
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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pinch and grasp dynamometer
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Modified Ashworth Scale, MAS
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Revised Nottingham Sensory Assessment
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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10-Meter Walking Test, 10MWT
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Box and Block Test, BBT
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Wolf Motor Function Test, WMFT
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Chedoke Arm and Hand Activity Inventory
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Canadian Occupational Performance Measure, COPM
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Nottingham Extended Activities of Daily Living, NEADL
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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ABILHAND Questionnaire
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Motor Activity Log, MAL
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Actigraphy
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Stroke Impact Scale, SIS
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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The World Health Organization Quality of Life -Brief version, WHOQOL-BRE
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Medical Research Council scale,MRC
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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6 minute walk test
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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The Euroqol Quality of Life Scale
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Lawton-Brody IADL Scale
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Pittsburg Sleep Quality Index
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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Montreal Cognitive Assessment, MoCA
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Minnesota Rate of Manipulation Test during dual Task
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Stroop Test
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Modified Rankin Scale, mRS
Временное ограничение: baseline
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baseline
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30 second sit-to-stand test
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Timed up and go test
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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The stroke self-efficacy questionnaire
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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BDI-II，Beck Depression Inventory II
Временное ограничение: Change from baseline up to 4 weeks immediately after the completion of intervention
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Change from baseline up to 4 weeks immediately after the completion of intervention
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 сентября 2014 г.
Первичное завершение (Действительный)
12 апреля 2017 г.
Завершение исследования (Действительный)
12 апреля 2017 г.
Даты регистрации исследования
Первый отправленный
14 января 2015 г.
Впервые представлено, что соответствует критериям контроля качества
10 февраля 2015 г.
Первый опубликованный (Оценивать)
18 февраля 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
19 мая 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
17 мая 2017 г.
Последняя проверка
1 ноября 2016 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 103-3962A3
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. .