The Enriched Environment as an Integrated Tool in the Ward Setting
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: Enriched environment.
- Кому может быть актуально
- Состояния в реестре: Stroke, Stroke, Acute. 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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Официальное название
The Enriched Environment as an Integrated Tool in the Ward Setting for Improving Functional Outcome in People With Acute Stroke: a Study Within the Neurological Clinic Unit
Обзор
The goal of this longitudinal interventional study is to integrate the enriched environment (EE) in the context of the Neurology Clinic ward of the General Hospital - University of Padua, by verifying its effectiveness and impact on psychological well-being, functional recovery, activity level, and quality of life in people with stroke.
Подробное описание
The EE will be integrated within the shared areas of the Neurology ward and in inpatient rooms, providing materials and aids to encourage physical, cognitive and social activity. The study will recruit for 9 months plus 6 months of follow-up. It will recruited a total of 50 people with stroke (25 for experimental and control group). After providing informed consent, participants will be evaluated on admission, at discharge, at 4 weeks (follow-up phone interview) and at 6 months (telephone interview). Participants will be psuedo randomized, as the ward will be environmentally enriched during consecutive alternating time frames. The instrument used to measure the multidimensional recovery will be the Stroke Impact Scale. Specific secondary outcomes will assessed the recovery in motor, cognitive and communication function, the impact on physical activity, mood, the type of activity of participants exposed to EE and the impact on the ward organization.
Вмешательства
- Другое Enriched environment
In the experimental group (enriched environment), assistants will supervise participants sponatneoulsy engaging in activities, including listening to music, drawing, playing cards or board games, exercising the affected upper limb with constructions or puzzles, etc., in the living room and personal rooms. Posters and clocks will also aid in orientation and improve the physical environment.
Первичные конечные точки
- Stroke Impact Scale [Срок оценки: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
Вторичные конечные точки (10)
- Functional Independence Measure (FIM) scale [Срок оценки: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Functional Assessment Test for Upper Limb [Срок оценки: T0: baseline (enrollment), T1: immediately after intervention (discharge)]
- Functional Ambulatory Category (FAC) [Срок оценки: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Dynamic Gait Index (DGI) if FAC > 3 [Срок оценки: T0: baseline (enrollment), T1: immediately after intervention (discharge)]
- Oxford Cognitive Screening (OCS) [Срок оценки: T0: baseline (enrollment), T1: immediately after intervention (discharge)]
- Typical values of Physical Activity Level (PAL) [Срок оценки: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Hospital Anxiety and Depression Scale (HADS) [Срок оценки: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Motor Activity Log [Срок оценки: T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)]
- Ad hoc behavioral mapping checklist [Срок оценки: T0: baseline (enrollment), T1: immediately after intervention (discharge)]
- Ad hoc questionnaire for health care workers [Срок оценки: T1: post intervention]
Критерии участия
Критерии включения
- Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment;
- Participant consent to participate in the study;
- Mecial stabilisation.
Критерии исключения
- Uncooperative participant, as assessed by theMontreal Cognitive Assessment scale < 15
- medically not stabtability and/or reduced level of consciousness and/or psychomotor agitation;
- Lack of trunk control (score <12 in item 3 of the Trunk Control Test: balance in sitting position) such that it is impossible to maintain a sitting position or a safe posture in a wheelchair;
- Speech evaluation confirming comprehension aphasia hampering understanding of informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Италия · 1 центр
- Teaching Hospital, University of Padova — Padova
Идентификаторы
NCT: NCT06233682 · PROTOCOL_ENVIRONMENT