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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Stroke Impact Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischaemic or haemorrhagic stroke, in any territory, occurring at least 24 hours before enrollment;
- •Participant consent to participate in the study;
- •Mecial stabilisation.
排除标准
- •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.
结局指标
主要结局
Stroke Impact Scale
时间窗: T0: baseline (enrollment), T1: immediately after intervention (discharge), T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview)
The Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. SIS is a 59-item measure. Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item. Summative scores are generated for each domain, scores range from 0-100.
次要结局
- Functional Independence Measure (FIM) scale(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(T0: baseline (enrollment), T1: immediately after intervention (discharge))
- Functional Ambulatory Category (FAC)(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(T0: baseline (enrollment), T1: immediately after intervention (discharge))
- Oxford Cognitive Screening (OCS)(T0: baseline (enrollment), T1: immediately after intervention (discharge))
- Typical values of Physical Activity Level (PAL)(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)(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(T2: 4 weeks post intervention (telephone interview), T3: 6 months post intervention (telephone interview))
- Ad hoc behavioral mapping checklist(T0: baseline (enrollment), T1: immediately after intervention (discharge))
- Ad hoc questionnaire for health care workers(T1: post intervention)
研究者
Alessandra Del Felice
Associate Professor of Physical and Rehabilitation Medicine
University of Padova