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Идёт набор NCT07591272

Adaptive Dance Activities for People With Stroke

Без фазы С лечением Stroke

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: Movement Improvisation Skill-building and Adaptive Dance Intervention.
Кому может быть актуально
Состояния в реестре: Stroke. Базовые параметры: 18 лет — 80 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Improving Participation in Stroke Survivors With Hemiparesis by Movement Improvisation Skill Building and Care Transition-friendly Adaptive Dance Activities: A Randomised Controlled Trial

Обзор

The project will investigate the effects of a novel 12-week Movement Improvisation Skill-building and Adaptive Dance Intervention (MDI) on participation, balance, mobility, balance confidence, psychological well-being, and health-related quality of life in survivors with hemiparesis.

Подробное описание

A 2-arm, assessor-blinded, randomised controlled trial will be conducted. Individuals who are 18-80 years old and have hemiparesis after a first-ever/recurrent ischaemic/haemorrhagic stroke will be recruited. The participants will be randomly allocated to the control group receiving usual care or the intervention group receiving MDI and usual care. Based on Bandura's principles of Self-efficacy and Outcome Expectation, MDI is an online/hybrid intervention aimed to assist survivors in developing body awareness, body sense, movement improvisational skills, and abilities in creating mental images of movements and balance during their transition of care from the acute settings to home. The outcomes will be assessed before the intervention, immediately post-intervention, and 3 and 6 months post-intervention.

Вмешательства

  • Другое Movement Improvisation Skill-building and Adaptive Dance Intervention
    The MDI is a hybrid in-person/online intervention aimed at developing body awareness, body sense, movement improvisational skills, and abilities in creating mental images of movements and balance among stroke survivors with hemiparesis.

Первичные конечные точки

  • Change in the level of participation in daily and social activities [Срок оценки: From baseline to immediately, 3 months and 6 months post-intervention]
Вторичные конечные точки (5)
  • Change in the level of balancing ability [Срок оценки: From baseline to immediately, 3 months and 6 months post-intervention]
  • Change in the level of mobility [Срок оценки: From baseline to immediately, 3 months and 6 months post-intervention]
  • Change in the level of balance confidence [Срок оценки: From baseline to immediately, 3 months and 6 months post-intervention]
  • Change in the level of psychological well-being [Срок оценки: From baseline to immediately, 3 months and 6 months post-intervention]
  • Change in the level of health-related quality of life [Срок оценки: From baseline to immediately, 3 months and 6 months post-intervention]

Критерии участия

Критерии включения

  • a first-ever/recurrent ischaemic/haemorrhagic stroke confirmed by imaging tests,
  • receiving in-patient care at an acute stroke unit,
  • a National Institutes of Health Stroke Scale (NIHSS) total score of <16 (mild to moderate stroke),
  • hemiparesis after stroke with the affected limb(s) scoring 1-3 on the NIHSS motor arm and/or motor leg items, respectively (drift to no effort against gravity),
  • a modified Rankin Scale (mRS) score of 2-4 (slight to moderately severe disability), and
  • a Montreal Cognitive Assessment (MoCA) score of >2nd percentile.

Критерии исключения

  • transient ischaemic attack,
  • subdural or epidural haemorrhage,
  • cerebrovascular event due to brain tumour or a head injury,
  • neurologic, orthopaedic, muscular, rheumatic or vestibular condition that can interfere with participation in the intervention such as seizure or spinal injury,
  • mental condition such as depression or schizophrenia, or
  • visual or auditory impairment that cannot be corrected by visual/hearing aids.

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
Организация здравоохранения

Центры проведения

Гонконг · 1 центр
  • Non-government organisations — Гонконг

Идентификаторы

NCT: NCT07591272 · 14618024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗