Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA)
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: HABIT-ILE, Conventional intervention.
- Кому может быть актуально
- Состояния в реестре: Acquired Brain Injury. Базовые параметры: 5 лет — 18 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
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Implementation of a HABIT-ILE Intervention at William Lennox Neurological : a Randomized Controlled Trial
Обзор
Using a randomized controlled trial design, in an hospital environment, possible changes induced by the "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of children with acquired brain injury.
Подробное описание
The aim is to investigate, for the first time, the effectiveness of HABIT-ILE therapy in a hospital setting in the treatment of a population representative of the clinical population with children with acquired brain injuries.
The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to children with acquired brain injury, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods.
The aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (HABIT-ILE) on body functions and structures, activity and participation in children with acquired brain injury.
Вмешательства
- Поведенческое HABIT-ILE
2 weeks HABIT-ILE - Поведенческое Conventional intervention
2 weeks usual intervention (waitlist group)
Первичные конечные точки
- Flanker task [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes in Gross Motor Function Measurement (GMFM 66) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Вторичные конечные точки (12)
- Changes in isometric muscular strength (Jamar) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Stroop task [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes in unimanual dexterity: Box and Blocks test (BBT) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes on bimanual function (Assisting Hand Assessment (AHA)) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes in 6 Minutes Walking Test (6MWT) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes in Pediatric balance scale (PBS) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes in Canadian Occupational Performance Measure (COPM) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes in ACTIVLIM-CP questionnaire [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes in Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes in Pediatric quality of life inventory (PedsQL) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Changes in Measure of Processes of Care (MPOC-20) [Срок оценки: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
- Status in Wechsler Intelligence Scale for Children-Non verbal short version (WISC) [Срок оценки: T0 (baseline)]
Критерии участия
Критерии включения
- children with acquired brain injury of school
- age 5 to 18 years inclusive
Критерии исключения
- Unstable seizure
- programmed botulinum toxin or orthopedic surgery in the 6 months previous to the intervention, during intervention period or 3months after the intervention time
- Severe visual or cognitive impairments likely to interfere with intervention or testing session completion
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Бельгия · 3 центра
- Centre Hospitalier Neurologique William Lennox — Ottignies-Louvain-la-Neuve
- Institute of Neurosciences, UCLouvain — Brussels
- Spontaneous contact via doctors or other partners — Brussels
Идентификаторы
NCT: NCT05900778 · B0392023000044