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Predicting Real World Physical Activity and Upper Limb Use After Stroke (REUSE)

2021年11月25日 更新者:University of Zurich

Profiling and Predicting the Natural Course of Real World Physical Activity and Upper Limb Use After Stroke

Poststroke recovery mainly takes place within the first weeks to months and about 95% of the patients reach their maximum recovery 3 months after stroke onset. Poststroke rehabilitation is initiated as early as possible and aims to reduce functional consequences of stroke, allowing patients to integrate into the community. However, up to 75% of the patients remain disabled in the long term. Strikingly, about 20 to 30% of the patients show functional decline (i.e., learned-nonuse) in the long term - most often after having finished their intensive rehabilitation period - and even stroke survivors who have little or no residual disability are less physically active when compared to their age-matched peers.

Poststroke outcomes can be well predicted early after stroke. However, the deficits early after stroke and the outcomes are measured by standardized clinical tests performed in the laboratory. The drawback of these tests is that they provide information about the best possible abilities of the patients, as they are encouraged by therapists in testing situations. This so called "capacity" does not necessarily reflect what patients do in daily life situations (i.e., "performance" or "real world use").

With the growing interest in the patients' performance, various assessments that objectively measure activities in daily life situations have been developed in the last few years. These devices capture movement in daily life situations in a sensitive and objective way. An additional benefit is that they are less hampered by floor or ceiling effects when compared to clinical laboratory measurements (i.e., clinimetrics). Nevertheless, outcome of real world performance is hardly ever used in clinical trials aiming to determine the effectiveness of stroke rehabilitation interventions. Actually, until today, the natural course of performance remains largely unknown, as are predictors for this course. It is also unknown to which extend patients' subjective reporting of performance matches objectively measured performance. Finally, although it is believed that there is a threshold for, for example, real life use of the paretic arm and further improvement, there is no evidence as to what this threshold is in terms of clinical laboratory measurements.

The present prospective longitudinal cohort study fills in the gap regarding knowledge about the profile and predictability of two performance outcomes during the first year poststroke: engagement in physical activities and the use of the paretic upper limb. In addition, it will provide insight in how physical activity engagement and upper limb use measured by daily life assessments relate to standard clinical laboratory assessments. This knowledge is a prerequisite for the identification of patients' phenotypes and a first essential step towards the development of tailored (i.e., precision medicine), innovative rehabilitation interventions which enhance performance in terms of physical activities or upper limb use in daily life. The ultimate goal is to reduce poststroke disability and associated costs.

RE-USE is a prospective longitudinal observational cohort study of 120 first-ever stroke patients, who will be assessed 3, 10, 28, 90 and 365 days after stroke onset, as well as at discharge of the rehabilitation center.

研究概览

研究类型

观察性的

注册 (实际的)

98

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Zurich、瑞士、8091
        • University Hospital Zurich

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Admitted to hospital

描述

Inclusion Criteria:

  • First-ever ischemic or hemorrhagic stroke, confirmed by MRI-DWI and/or CT (recurrent strokes are allowed when already included in this study after a first-ever stroke)
  • Paresis or paralysis of the arm and/ or leg
  • Living independently before stroke (mRS >2)
  • Age 18 years or older
  • Written informed consent of the patient or its legal representative after participants' information

Exclusion Criteria:

  • Contra-indications on ethical grounds (vulnerable persons)
  • Neurological or other diseases affecting upper limb use and/ or physical activity before stroke
  • Known or suspected non-compliance, drug or alcohol abuse

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Assessment of real world performance
Patients will be assessed by using movement sensors and standard clinical assessments

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Daily life assessment of physical activity engagement and upper limb use
大体时间:90 days after stroke onset
Real world performance, measured with movement sensors (number)
90 days after stroke onset

次要结果测量

结果测量
措施说明
大体时间
Neurological impairments
大体时间:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
National Institutes of Health Stroke Scale (0-42 points, lower scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb motor function
大体时间:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fugl-Meyer Assessment (0-66 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motor function
大体时间:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motricity Index (0-200 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Trunk ability
大体时间:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Trunk Control Test (0-100 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Sitting and standing balance
大体时间:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Berg Balance Scale (0-56 points, higher scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Walking ability (independence)
大体时间:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Functional Ambulation Categories (0-5 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Gait speed and cadence (time)
大体时间:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Ten-Meter Walk Test
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity
大体时间:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Action Research Arm Test (0-56 points, higher scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity dexterity
大体时间:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Box and Block Test (number of blocks)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Global disability
大体时间:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Modified Rankin Scale (0-6 points, lower scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fatigue
大体时间:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fatigue Severity Scale (9-63 point, lower scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Cognition
大体时间:3 and 90 days after stroke onset
Montreal Cognitive Assessment(0-30 points, higher scores being better)
3 and 90 days after stroke onset
Neglect
大体时间:3 and 90 days after stroke onset
Apples Test (number)
3 and 90 days after stroke onset
Patient-reported physical activity
大体时间:90 and 365 days after stroke onset
International Physical Activity Questionnaire (3 levels higher levels are better)
90 and 365 days after stroke onset
Patient-reported daily life upper limb use
大体时间:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motor Activity Log - 14 item version (0-5 points, higher scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Patient-reported changes
大体时间:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Global Rating of Perceived Changes (1-7 points, higher scores being better; 1-10 points, lower scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Concomitant movement therapy
大体时间:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Intensity of therapy based on charts (minutes)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Serious Events and non-serious infections or cardiovascular events
大体时间:3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Serious Events (1. death; 2. life-threatening illness or injury; 3. in-patient or prolonged hospitalisation; 4. medical or surgical intervention to prevent life threatening illness; 5. led to fetal distress, death or a congenital abnormality or birth defect) and non-serious infections or cardiovascular events
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Daily life assessment of physical activity engagement and upper limb use
大体时间:3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
Real world performance, measured with movement sensors (number)
3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
Levels of anxiety and depression
大体时间:10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Hospital Anxiety and Depression Scale (0-42 points, higher scores indicate greater levels of anxiety or depression)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Health care costs and loss of income
大体时间:365 days after stroke onset
Health care costs and loss of income in relation to the stroke (CHF)
365 days after stroke onset

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Andreas R Luft, Prof. Dr.、University of Zurich, University Hospital Zurich

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年9月1日

初级完成 (实际的)

2021年3月31日

研究完成 (实际的)

2021年3月31日

研究注册日期

首次提交

2018年4月16日

首先提交符合 QC 标准的

2018年4月30日

首次发布 (实际的)

2018年5月11日

研究记录更新

最后更新发布 (实际的)

2021年11月29日

上次提交的符合 QC 标准的更新

2021年11月25日

最后验证

2021年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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