Prognostic Recovery Observations and Guidance for Evaluating Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Haemorrhagic or ischaemic stroke confirmed by a clinical diagnosis and by brain imaging
- •NIHSS item 5-6 ≥1
- •3 to 10 days post-stroke
排除标准
- •Transient ischaemic attack
- •Premorbid Modified Rankin Scale ≥ 4
- •Acute orthopaedic complications
- •Inability to give informed consent
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: Within 3-10 days post stroke and at the three-month, six-month and one-year follow-up
To evaluate upper limb functional recovery. The score ranges from 0 (indicating low functional recovery) to 57 (high functional recovery).
次要结局
- Timed Up and Go Test (TUG)(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)(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)(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)(Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up)
- Barthel Index (BI)(Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up)
- Functional Ambulation Classification (FAC)(Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up)
- Ashworth Scale (AS)(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)(Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up)
- 10 Meters Walking Test (10MWT)(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)(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)(Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up)
- Motricity Index (MI)(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)(Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up)
- ABILHAND(Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up)
- 6 Minutes Walking Test (6MWT)(Assessments will occur within 3-10 days post stroke and at the three-month, six-month and one-year follow-up)
研究者
Prof. Massimo Filippi
Professor in Neurology and Director of Stroke Unit, Neurology and neurorehabilitation Units
IRCCS San Raffaele