- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT02096445
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
9 июня 2017 г. обновлено: Roger Gassert
The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke.
It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties.
In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy.
The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later.
The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible.
This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists.
The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions.
This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.
Обзор исследования
Статус
Завершенный
Условия
Тип исследования
Интервенционный
Регистрация (Действительный)
34
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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Ticino
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Brissago, Ticino, Швейцария, 6614
- Clinica Hildebrand Centro di riabilitazione Brissago
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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 18 лет до 90 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- age between 18-90 years old
- hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 - M5 on the paresis scale) as a result of a first stroke
- sub-acute lesion not more than 6 weeks post ictus
Exclusion Criteria:
- insufficient state of consciousness
- severe aphasia
- severe cognitive deficits
- severe pathologies of the upper extremity of traumatic or rheumatic nature
- severe pain in the affected arm
- Patients with pacemakers and other active implants
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: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Robot group
Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy. (4 x 45 min/week) |
2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
Другие имена:
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Активный компаратор: Control group
Receive dose-matched conventional neurocognitive therapy
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Use sensory perception (tactile, proprioception but not vision!) to solve a by the therapist guided (passive) or patient controlled (active) therapy task, e.g.
discrimination/identification of different spring resistances, sponges, different sized blocks, etc.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Motor impairment of the upper limb
Временное ограничение: Change from Baseline in motor impairment of the upper limb at 4 weeks
|
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
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Change from Baseline in motor impairment of the upper limb at 4 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Motor impairment of the upper limb
Временное ограничение: Change from Baseline in motor impairment of the upper limb at 8 weeks
|
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
|
Change from Baseline in motor impairment of the upper limb at 8 weeks
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Motor impairment of the upper limb
Временное ограничение: Change from Baseline in motor impairment of the upper limb at 6 months
|
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
|
Change from Baseline in motor impairment of the upper limb at 6 months
|
|
Functional improvement in dexterity
Временное ограничение: Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
|
Functional improvement in dexterity is assessed with the Box and Block Test
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Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
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Functional improvement in dexterity
Временное ограничение: Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
|
Functional improvement in dexterity is assessed with the Box and Block Test
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Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
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Functional improvement in dexterity
Временное ограничение: Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
|
Functional improvement in dexterity is assessed with the Box and Block Test
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Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
|
|
Spasticity level of the upper limb
Временное ограничение: Change from Baseline in spasticity level of the upper limb at 4 weeks
|
Spasticity level is measured with the Modified Ashworth Scale
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Change from Baseline in spasticity level of the upper limb at 4 weeks
|
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Spasticity level of the upper limb
Временное ограничение: Change from Baseline in spasticity level of the upper limb at 8 weeks
|
Spasticity level is measured with the Modified Ashworth Scale
|
Change from Baseline in spasticity level of the upper limb at 8 weeks
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Spasticity level of the upper limb
Временное ограничение: Change from Baseline in spasticity level of the upper limb at 6 months
|
Spasticity level is measured with the Modified Ashworth Scale
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Change from Baseline in spasticity level of the upper limb at 6 months
|
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Tactile and proprioceptive sensory function of the upper limb
Временное ограничение: Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
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Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment
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Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
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Tactile and proprioceptive sensory function of the upper limb
Временное ограничение: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
|
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
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Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
|
|
Tactile and proprioceptive sensory function of the upper limb
Временное ограничение: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
|
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
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Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
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Neglect
Временное ограничение: Change from Baseline in neglect at 4 weeks
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Neglect is assessed with the Albert's test of neglect
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Change from Baseline in neglect at 4 weeks
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Neglect
Временное ограничение: Change from Baseline in neglect at 8 weeks
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Neglect is assessed with the Albert's test of neglect
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Change from Baseline in neglect at 8 weeks
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Neglect
Временное ограничение: Change from Baseline in neglect at 6 months
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Neglect is assessed with the Albert's test of neglect
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Change from Baseline in neglect at 6 months
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Cognitive impairment
Временное ограничение: Change from Baseline in cognitive impairment at 4 weeks
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Cognitive impairment is assessed with the Mini Mental State Examination
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Change from Baseline in cognitive impairment at 4 weeks
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Cognitive impairment
Временное ограничение: Change from Baseline in cognitive impairment at 8 weeks
|
Cognitive impairment is assessed with the Mini Mental State Examination
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Change from Baseline in cognitive impairment at 8 weeks
|
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Cognitive impairment
Временное ограничение: Change from Baseline in cognitive impairment at 6 months
|
Cognitive impairment is assessed with the Mini Mental State Examination
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Change from Baseline in cognitive impairment at 6 months
|
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Frontal lobe function
Временное ограничение: Change from Baseline in frontal lobe function at 4 weeks
|
Frontal lobe function is assessed with the Frontal assessment battery
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Change from Baseline in frontal lobe function at 4 weeks
|
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Frontal lobe function
Временное ограничение: Change from Baseline in frontal lobe function at 8 weeks
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Frontal lobe function is assessed with the Frontal assessment battery
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Change from Baseline in frontal lobe function at 8 weeks
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Frontal lobe function
Временное ограничение: Change from Baseline in frontal lobe function at 6 months
|
Frontal lobe function is assessed with the Frontal assessment battery
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Change from Baseline in frontal lobe function at 6 months
|
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Aphasia
Временное ограничение: Change from Baseline in aphasia at 4 weeks
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Aphasia is assessed with the Aachener Aphasia Test
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Change from Baseline in aphasia at 4 weeks
|
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Aphasia
Временное ограничение: Change from Baseline in aphasia at 8 weeks
|
Aphasia is assessed with the Aachener Aphasia Test
|
Change from Baseline in aphasia at 8 weeks
|
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Aphasia
Временное ограничение: Change from Baseline in aphasia at 6 months
|
Aphasia is assessed with the Aachener Aphasia Test
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Change from Baseline in aphasia at 6 months
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Attention
Временное ограничение: Change from Baseline in attention at 4 weeks
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Attention is assessed with the test to identify attention
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Change from Baseline in attention at 4 weeks
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Attention
Временное ограничение: Change from Baseline in attention at 8 weeks
|
Attention is assessed with the test to identify attention
|
Change from Baseline in attention at 8 weeks
|
|
Attention
Временное ограничение: Change from Baseline in attention at 6 months
|
Attention is assessed with the test to identify attention
|
Change from Baseline in attention at 6 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Директор по исследованиям: Roger Gassert, Prof. Dr., Rehabilitation Engineering Lab, ETH Zurich
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Metzger JC, Lambercy O, Califfi A, Conti FM, Gassert R. Neurocognitive robot-assisted therapy of hand function. IEEE Trans Haptics. 2014 Apr-Jun;7(2):140-9. doi: 10.1109/TOH.2013.72.
- Ranzani R, Lambercy O, Metzger JC, Califfi A, Regazzi S, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Neurocognitive robot-assisted rehabilitation of hand function: a randomized control trial on motor recovery in subacute stroke. J Neuroeng Rehabil. 2020 Aug 24;17(1):115. doi: 10.1186/s12984-020-00746-7.
- Metzger JC, Lambercy O, Califfi A, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Assessment-driven selection and adaptation of exercise difficulty in robot-assisted therapy: a pilot study with a hand rehabilitation robot. J Neuroeng Rehabil. 2014 Nov 15;11:154. doi: 10.1186/1743-0003-11-154.
Полезные ссылки
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 (Действительный)
1 апреля 2013 г.
Первичное завершение (Действительный)
10 марта 2017 г.
Завершение исследования (Действительный)
9 июня 2017 г.
Даты регистрации исследования
Первый отправленный
19 марта 2014 г.
Впервые представлено, что соответствует критериям контроля качества
21 марта 2014 г.
Первый опубликованный (Оценивать)
26 марта 2014 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
12 июня 2017 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
9 июня 2017 г.
Последняя проверка
1 июня 2017 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- CIV-13-02-009921
- 2013-MD-0002 (Другой идентификатор: Swissmedic)
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. .