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.
Study Type
OBSERVATIONAL
Enrollment
98
Patients will be assessed by using movement sensors and standard clinical assessments
University Hospital Zurich
Zurich, Switzerland
Daily life assessment of physical activity engagement and upper limb use
Real world performance, measured with movement sensors (number)
Time frame: 90 days after stroke onset
Neurological impairments
National Institutes of Health Stroke Scale (0-42 points, lower scores being better)
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb motor function
Fugl-Meyer Assessment (0-66 points, higher scores being better)
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motor function
Motricity Index (0-200 points, higher scores being better)
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Trunk ability
Trunk Control Test (0-100 points, higher scores being better)
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Sitting and standing balance
Berg Balance Scale (0-56 points, higher scores being better)
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Walking ability (independence)
Functional Ambulation Categories (0-5 points, higher scores being better)
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Gait speed and cadence (time)
Ten-Meter Walk Test
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity
Action Research Arm Test (0-56 points, higher scores being better)
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity dexterity
Box and Block Test (number of blocks)
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Global disability
Modified Rankin Scale (0-6 points, lower scores being better)
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fatigue
Fatigue Severity Scale (9-63 point, lower scores being better)
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Cognition
Montreal Cognitive Assessment(0-30 points, higher scores being better)
Time frame: 3 and 90 days after stroke onset
Neglect
Apples Test (number)
Time frame: 3 and 90 days after stroke onset
Patient-reported physical activity
International Physical Activity Questionnaire (3 levels higher levels are better)
Time frame: 90 and 365 days after stroke onset
Patient-reported daily life upper limb use
Motor Activity Log - 14 item version (0-5 points, higher scores being better)
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Patient-reported changes
Global Rating of Perceived Changes (1-7 points, higher scores being better; 1-10 points, lower scores being better)
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Concomitant movement therapy
Intensity of therapy based on charts (minutes)
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Serious Events and non-serious infections or cardiovascular events
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
Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Daily life assessment of physical activity engagement and upper limb use
Real world performance, measured with movement sensors (number)
Time frame: 3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
Levels of anxiety and depression
Hospital Anxiety and Depression Scale (0-42 points, higher scores indicate greater levels of anxiety or depression)
Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Health care costs and loss of income
Health care costs and loss of income in relation to the stroke (CHF)
Time frame: 365 days after stroke onset
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