Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Acute Stroke, Functional Recovery, Prognostic Factors. Базовые параметры: от 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
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This research delves into the acute prognostic factors influencing functional recovery in individuals who have experienced a stroke. The objective is to describe patterns of functional recovery after a stroke and identify new, clinically significant outcomes or metrics that can serve as predictive indicators for post-stroke functional recovery.
Подробное описание
In this prospective observational study with additional procedures, the aim is to describe different patterns of recovery according to clinical characteristics identified during the early phases post stroke. All the additional procedure are functional and clinical tests or questionnaires validated and used for standard stroke clinical practice that pose no risk to the enrolled subject. This study, based at San Raffaele Hospital's stroke unit, will enrol subjects who suffer from stroke assessed in the acute phase (T0), at three-months (T1), six-month (T2) and 1-year post-stroke (T3). No intervention that can interfere with usual clinical practice will be administered between evaluations. Assessments include neurological, neuropsychological and physical therapy questionnaires along with functional tests validated and used in stroke clinical practice.
Первичные конечные точки
- Action Research Arm Test (ARAT) [Срок оценки: Within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
Вторичные конечные точки (12)
- Functional Ambulation Classification (FAC) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Modified Rankin Scale (MRS) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Fugl-Meyer Assessment for upper and lower limb (FMA- UL and LL) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Montreal Cognitive Assessment (MOCA) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Hospital Anxiety and Depression Scale (HADS) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Barthel Index (BI) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Motricity Index (MI) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Ashworth Scale (AS) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Medical Research Council Scale (MRC) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- ABILHAND [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Trunk Control Test (TCT) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
- Mini Balance Evaluation Test (Mini-BESTest) [Срок оценки: Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up]
Критерии участия
Критерии включения
- Age ≥ 18
- Haemorrhagic or ischaemic stroke confirmed by a clinical diagnosis and by brain imaging
- NIHSS item 5-6 ≥1
- 3 to 10 days post-stroke
Критерии исключения
- Transient ischaemic attack
- Premorbid Modified Rankin Scale ≥ 4
- Acute orthopaedic complications
- Inability to give informed consent
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Италия · 1 центр
- IRCCS San Raffaele — Milan
Идентификаторы
NCT: NCT06465758 · PROGRESS