The Implementation of PREP2 Algorithms Into Clinical Practice: a Strategy for Improving Rehabilitation Efficiency and Clinical Outcomes After Stroke. A Single-site Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Stroke Impact Scale 3.0 between three time points
研究概览
简要总结
Stroke is a worldwide major cause of disability with great social and economic burdens. The recovery of motor function is crucial for the patient to regain independence and quality of life. Identifying early predictors of motor recovery and outcomes is useful for planning personalized rehabilitation programs and increasing their efficiency. However, making predictions using a single clinical assessment is often difficult and a combination of multiple tools is required. In the last decades, were validated two predictive algorithms for upper limb function and independent walking that can be easily implemented into clinical practice with the aim of increasing knowledge on expected outcome after stroke in patients, families and rehabilitation teams. This will be the first single-site randomized control trial that will test the implementation of such tools in a rehabilitation setting in Italy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of stroke;
- •new upper and/or lower limb weakness.
排除标准
- •cerebellar or bilateral stroke;
- •contraindication to TMS;
- •cognitive or communication impairment precluding informed consent;
- •assisted walking prior to admission;
- •severe medical conditions.
结局指标
主要结局
Change in Stroke Impact Scale 3.0 between three time points
时间窗: week 4, 12, week 26
To evaluate how stroke has impacted your health and life.
Change in Fugl-Meyer Assessment between three time points
时间窗: week 4, 12, week 26
To assess the sensorimotor impairment in individuals who have had stroke.
Change in Rehabilitation Complexity Scale between two time points
时间窗: Baseline, hospital discharge (an average of 3-6 months)
Measure of the complexity of rehabilitation needs and/or interventions.
Change in Rehabilitation strategies between two time points
时间窗: Baseline, week 4
Will be assessed tracking: therapists confidence about patients' recovery (0-5 Likert scale); therapy content; therapy duration.
Rehabilitation LOS (days)
时间窗: Hospital discharge (an average of 3-6 months)
Length of stay as measure of rehabilitation efficiency
Change in Kinematic data recordings between three time points
时间窗: week 4, week 12, week 26
Kinematic data of trunk and affected hand will be recorded during subject imitations. Kinematic data will be recorded with the aim of characterizing the PREP2 recovery classes.
Change in Functional International Measure between two time points
时间窗: Baseline, hospital discharge (an average of 3-6 months)
Measure of efficiency of rehabilitation. Assess a patient's level of disability as well as change in patient status in response to rehabilitation.
Change in Action Research Arm Test between three time points
时间窗: week 4, 12, week 26
To assess upper extremity performance (coordination, dexterity and functioning)
Change in Electroencephalography power in beta band between three time points
时间窗: week 4, week 12, week 26
EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.
Change in Electroencephalography power in alpha band between three time points
时间窗: week 4, week 12, week 26
EEG data will be recorded with the aim of characterizing the PREP2 recovery classes.
次要结局
- Applicability perception and satisfaction degree of the proposed intervention self-report questionnaire.(week 4)
研究者
Sofia Straudi
Clinical Professor
University Hospital of Ferrara