Predicting Real World Physical Activity and Upper Limb Use After Stroke
- Conditions
- Stroke
- Interventions
- Behavioral: Real world performance of physical activity and arm use
- Registration Number
- NCT03522519
- Lead Sponsor
- University of Zurich
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Assessment of real world performance Real world performance of physical activity and arm use -
- Primary Outcome Measures
Name Time Method Daily life assessment of physical activity engagement and upper limb use 90 days after stroke onset Real world performance, measured with movement sensors (number)
- Secondary Outcome Measures
Name Time Method Trunk ability 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Trunk Control Test (0-100 points, higher scores being better)
Sitting and standing balance 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Berg Balance Scale (0-56 points, higher scores being better)
Walking ability (independence) 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Functional Ambulation Categories (0-5 points, higher scores being better)
Gait speed and cadence (time) 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Ten-Meter Walk Test
Upper limb capacity 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Action Research Arm Test (0-56 points, higher scores being better)
Neurological impairments 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)
Upper limb motor function 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Fugl-Meyer Assessment (0-66 points, higher scores being better)
Motor function 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Motricity Index (0-200 points, higher scores being better)
Upper limb capacity dexterity 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Box and Block Test (number of blocks)
Global disability 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Modified Rankin Scale (0-6 points, lower scores being better)
Fatigue 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Fatigue Severity Scale (9-63 point, lower scores being better)
Cognition 3 and 90 days after stroke onset Montreal Cognitive Assessment(0-30 points, higher scores being better)
Patient-reported physical activity 90 and 365 days after stroke onset International Physical Activity Questionnaire (3 levels higher levels are better)
Patient-reported daily life upper limb use 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)
Patient-reported changes 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)
Concomitant movement therapy 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset Intensity of therapy based on charts (minutes)
Serious Events and non-serious infections or cardiovascular events 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
Daily life assessment of physical activity engagement and upper limb use 3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset Real world performance, measured with movement sensors (number)
Levels of anxiety and depression 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)
Health care costs and loss of income 365 days after stroke onset Health care costs and loss of income in relation to the stroke (CHF)
Neglect 3 and 90 days after stroke onset Apples Test (number)
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zurich, Switzerland