- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02803255
AAN Robotic Therapy in SCI
Effect of Assist-as-needed Robot Aided Rehabilitation Strategies in Subjects With Incomplete Spinal Cord Injury
Обзор исследования
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 1
Контакты и местонахождение
Места учебы
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Texas
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Houston, Texas, Соединенные Штаты, 77030
- TIRR Memorial Hermann
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Houston, Texas, Соединенные Штаты, 77005
- Rice University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Twenty adults with chronic incomplete SCI (according to American Spinal Injury Association (ASIA) Impairment Scale (AIS) C-D level) will be recruited from TIRR and from the Houston area.
Inclusion Criteria:
- Providing written informed consent prior to any study related procedures;
- Age between 18-75 years;
- Diagnosis of chronic complete or incomplete spinal cord injury as defined by the American Spinal Injury Association Impairment scale classification and at least for 6 months;
- Not being involved in any specific exercise program (e.g., NMES, FES) within the previous 3 months;
- No planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
- Eligibility for standard rehabilitation at the time of enrollment (i.e., absence medical comorbidities that would prevent standard rehabilitation);
- No condition (e.g., severe arthritis, extreme shoulder pain) that would interfere with valid administration of the measures or with interpreting motor testing;
Exclusion Criteria: Subjects will be excluded if they have:
- Any joint contracture or severe spasticity in the affected upper extremity, as measured by a Modified Ashworth Score > than 3 out of 4;
- Subject who cannot provide self-transportation to the study location.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Assist-As-Needed Control
Subjects in this group will interact with a robotic exoskeleton, the MAHI Exo-II, programmed with an "adaptive mode". In this mode, the robot will continuously assist motion along pre-defined trajectories, but will employ an "assist-as-needed" protocol. Here, the amount of assistance provided by the robot will not be always the 100% of that required to complete the task (as in the position control mode), but only a fraction of it. The robot will continuously estimate the residual movement capabilities of the subject, depending on the specific joint addressed in the movement, and will estimate the remaining contribution needed to complete the movement following a predefined trajectory, thus avoiding to over-support motion. |
Другие имена:
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Активный компаратор: Subject-Triggered Control
Subjects in group B will interact with a robotic exoskeleton, the MAHI Exo-II, controlled via the subject-triggered mode, as in a previous clinical trial with the MAHI Exo II robotic system.
In the subject triggered mode, the MAHIExo II is commanded to regulate joints motion following a position-control control scheme, and using as desired trajectories standardized single-joints profiles that require motion of one of the axes of the exoskeleton (i.e.
elbow flexion and extension, forearm pronation and supination, wrist radial and ulnar deviation, wrist flexion and extension).
The switch to position control of the exoskeleton is triggered by the application of sufficient force by the subject, in a previous phase where the robot implements a virtual wall.
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Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
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Change in ARAT score
Временное ограничение: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Change in Modified Ashworth Scale
Временное ограничение: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in Grip Pinch Strength Assessment
Временное ограничение: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in Graded Redefined Assessment of Strength, Sensibility and Prehension
Временное ограничение: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in Smoothness metrics
Временное ограничение: Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Measured via analysis of point-to-point reaching movements performed with the robot.
Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
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Difference between values measured i) <1 week before treatment start and ii) <1 week after the end of the 2-4 week long treatment program
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Change in smoothness metrics
Временное ограничение: Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
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Measured via analysis of point-to-point reaching movements performed with the robot.
Extracted measures include the movement-arrest-period-ratio, the spectral arc length, and the normalized average speed
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Difference between values measured i) treatment start day and ii) session 10 of the therapy program - 2-4 weeks after treatment start
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Marcia K. O'Malley, PhD, William Marsh Rice University
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
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
- 14-027F
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. .
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