STroke RehabilitATion REgistrY for Predicting Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 4
- 主要终点
- Change in modified Barthel Index
研究概览
简要总结
Pathology registers are scientific research tools for the development of epidemiological and clinical studies and health planning, which allows access to useful elements for planning adequate health services. The Registry collects demographic, clinical and functional data of stroke patients and arises from the need to order and update this information for epidemiological and research purposes, for a better knowledge of this pathology from a rehabilitation point of view and to accelerate the development of new treatments.
详细描述
The Italian Society of Physical and Rehabilitation Medicine has published a minimal assessment protocol for stroke patients1 (PMIC2020) to share the evaluation of stroke rehabilitation needs and outcomes at any time of the rehabilitation pathway, as grounds for a National Stroke Rehabilitation Registry (SRR).
The STRATEGY multicentric study aims to verify the feasibility of implementing a PMIC2020-based SRR in a routine clinical setting, and develop data-driven prognosis prediction models.
Demographic, functional and clinical variables will be collected at the admission and the discharge of the patient; in addition, two telephone follow-ups (three months and six months from the event) will be carried out
The study will involve several rehabilitation centers of the Don Gnocchi Foundation, Italy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult patients (over 18 years of age) with ischemic or haemorrhagic stroke, first event or with relapse, time to onset of stroke less than 6 months, signature of informed consent by the patient or family member.
排除标准
- •Patients from Severe Acquired Brain Injuries units and / or with diseases that threaten the patient's life
结局指标
主要结局
Change in modified Barthel Index
时间窗: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)
measure of ability in activity of daily living range 0 worst- 100 best
次要结局
- Change in Short Physical Performance Battery(Admission, discharge (average 30 days from admission))
- Change in Motricity Index(Admission, discharge (average 30 days from admission))
- Change in Modified Ashworth Scale(Admission, discharge (average 30 days from admission))
- Change of Mini Mental State Examination(Admission, discharge (average 30 days from admission))
- Change in modified Rankin Score(Admission, discharge (average 30 days from admission), follow-up (6 months after stroke))
- Change in Functional Ambulation Category(Admission, discharge (average 30 days from admission), follow-up (6 months after stroke))
- Change in Trunk Control Test(Admission, discharge (average 30 days from admission))
研究者
Francesca Cecchi
Principal Investigator, Clinical Professor
Fondazione Don Carlo Gnocchi Onlus