Implementation of a HABIT-ILE Intervention at William Lennox Neurological Hospital (NeuREHA) - Adult
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: Stroke. Базовые параметры: 18 лет — 95 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 the William Lennox Neurological Centre for Sub-acute Adult Post-stroke Patients (<6 Mois): a Randomised 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 patients with sub-acute post-stroke
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 for adult patients with subacute stroke.
The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to patients with sub-acute post-stroke, 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 adulte patients suffering from subacute stroke..
Вмешательства
- Поведенческое HABIT-ILE
2 weeks HABIT-ILE - Поведенческое Conventional intervention
2 weeks usual intervention (waitlist group)
Первичные конечные точки
- Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke) [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
Вторичные конечные точки (12)
- Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE) [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in unimanual dexterity: Box and Blocks test (BBT) [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in Canadian Occupational Performance Measure (COPM) [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in the Stroke Impact Scale (SIS) [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in activities of daily living assessed by ABILHAND Questionnaire [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in visual neglect assessed by the Bells Test [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in the Montreal Cognitive Assessment (MoCA) test [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in balance control assessed by the mini Balance Evaluation System Test (mini BEST test) [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in the Two Minutes' Walk Test (2MWT) [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in National Institutes of Health Stroke Scale (NIHSS) [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]]
- Changes in Tardieu Scale et Modified Tardieu Scale (MTS) [Срок оценки: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
Критерии участия
Критерии включения
- Phase aiguë ou subaiguë
Критерии исключения
- Epilepsie instable
- Absence à déterminer sa volonté à participer
- Traitement toxine pendant le stage
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
- Institute of Neurosciences, UCLouvain — Brussels
- Institute of Neurosciences, UCLouvain — Brussels
- Spontaneous contact via doctors or other partners — Brussels
Идентификаторы
NCT: NCT06931795 · B0392023000045