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Идёт набор NCT07366697

Beyond Observation: Validating the Ecological Relevance of the Ad-AHA Stroke Using Sensor-Based Measures

— Наблюдательное Stroke Upper Limb Motor Impairment Bimanual Function

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: Sensor-based monitoring and clinical assessment.
Кому может быть актуально
Состояния в реестре: Stroke, Upper Limb Motor Impairment, Bimanual Function. 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
Бельгия
Следующий шаг
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Обзор

After a stroke, many people experience difficulty using both hands together in daily life. Most rehabilitation assessments, however, only measure how the affected arm performs in one-handed tasks. This makes it difficult to understand how well people actually use their hands in real-world activities, which are usually bimanual. The Adult Assisting Hand Assessment - Stroke version (Ad-AHA Stroke) is a new clinical test that evaluates how the affected hand performs during two-handed tasks. While promising, it is still unknown whether the score on this test truly reflects how stroke survivors use their hands in daily life. This study aims to investigate this question by comparing Ad-AHA Stroke scores with real-life data on hand use, recorded over three days using wrist-worn sensors on both arms. By combining clinical and sensor-based measures, this study will help determine whether the Ad-AHA Stroke can accurately represent everyday bimanual performance after stroke.

Подробное описание

This is a single-center, cross-sectional observational study designed to examine the relationship between Ad-AHA Stroke scores and real-life bimanual hand use derived from accelerometry data in chronic stroke survivors.

Вмешательства

  • Другое Sensor-based monitoring and clinical assessment
    Participants will complete the Ad-AHA Stroke assessment and wear bilateral wrist accelerometers for 3 days to measure real-life bimanual activity. No treatment or experimental intervention will be administered.

Первичные конечные точки

  • Correlation between Ad-AHA Stroke total score and accelerometer-derived Use Ratio [Срок оценки: Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period]
Вторичные конечные точки (1)
  • Correlation between Ad-AHA Stroke score and composite accelerometer index [Срок оценки: Baseline (measurement visit), including a continuous 72-hour wrist accelerometer monitoring period]

Критерии участия

Критерии включения

  • Written informed consent obtained prior to any study procedures.
  • Age between 18 and 80 years (inclusive).
  • Unilateral supratentorial stroke involving cortical or subcortical structures.
  • At least 6 months post-stroke at the time of inclusion.
  • Community-dwelling (discharged from hospital and currently living at home).
  • Able and willing to wear bilateral wrist-worn sensors (triaxial accelerometers) for three consecutive days.
  • Presence of clinically observable bimanual impairment.

Критерии исключения

  • Severe upper limb impairment, defined as a Fugl-Meyer Assessment of Upper Extremity (FMA-UE) score ≤ 15.
  • Severe cognitive or language comprehension impairment interfering with understanding of study instructions or task performance, as judged during screening.
  • Presence of other neurological or orthopedic conditions affecting upper limb function (e.g., Parkinson's disease, multiple sclerosis, severe osteoarthritis, brachial plexus injury).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Бельгия · 1 центр
  • Department of Rehabilitation Sciences, KU Leuven — Leuven

Идентификаторы

NCT: NCT07366697 · s70965

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗