- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522519
Predicting Real World Physical Activity and Upper Limb Use After Stroke (REUSE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zurich, Switzerland, 8091
- University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Assessment of real world performance
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Patients will be assessed by using movement sensors and standard clinical assessments
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily life assessment of physical activity engagement and upper limb use
Time Frame: 90 days after stroke onset
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Real world performance, measured with movement sensors (number)
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90 days after stroke onset
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurological impairments
Time Frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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National Institutes of Health Stroke Scale (0-42 points, lower scores being better)
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3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Upper limb motor function
Time Frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Fugl-Meyer Assessment (0-66 points, higher scores being better)
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3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Motor function
Time Frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Motricity Index (0-200 points, higher scores being better)
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3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Trunk ability
Time Frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Trunk Control Test (0-100 points, higher scores being better)
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3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Sitting and standing balance
Time Frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Berg Balance Scale (0-56 points, higher scores being better)
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10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Walking ability (independence)
Time Frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Functional Ambulation Categories (0-5 points, higher scores being better)
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3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Gait speed and cadence (time)
Time Frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Ten-Meter Walk Test
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10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Upper limb capacity
Time Frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Action Research Arm Test (0-56 points, higher scores being better)
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10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Upper limb capacity dexterity
Time Frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Box and Block Test (number of blocks)
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10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Global disability
Time Frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Modified Rankin Scale (0-6 points, lower scores being better)
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3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Fatigue
Time Frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Fatigue Severity Scale (9-63 point, lower scores being better)
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10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Cognition
Time Frame: 3 and 90 days after stroke onset
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Montreal Cognitive Assessment(0-30 points, higher scores being better)
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3 and 90 days after stroke onset
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Neglect
Time Frame: 3 and 90 days after stroke onset
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Apples Test (number)
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3 and 90 days after stroke onset
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Patient-reported physical activity
Time Frame: 90 and 365 days after stroke onset
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International Physical Activity Questionnaire (3 levels higher levels are better)
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90 and 365 days after stroke onset
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Patient-reported daily life upper limb use
Time Frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Motor Activity Log - 14 item version (0-5 points, higher scores being better)
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10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Patient-reported changes
Time Frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Global Rating of Perceived Changes (1-7 points, higher scores being better; 1-10 points, lower scores being better)
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10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Concomitant movement therapy
Time Frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Intensity of therapy based on charts (minutes)
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3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Serious Events and non-serious infections or cardiovascular events
Time Frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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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
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3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
|
Daily life assessment of physical activity engagement and upper limb use
Time Frame: 3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
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Real world performance, measured with movement sensors (number)
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3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
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Levels of anxiety and depression
Time Frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Hospital Anxiety and Depression Scale (0-42 points, higher scores indicate greater levels of anxiety or depression)
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10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
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Health care costs and loss of income
Time Frame: 365 days after stroke onset
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Health care costs and loss of income in relation to the stroke (CHF)
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365 days after stroke onset
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Andreas R Luft, Prof. Dr., University of Zurich, University Hospital Zurich
Publications and helpful links
General Publications
- Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 Sep 2. No abstract available.
- Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- Bailey RR, Klaesner JW, Lang CE. Quantifying Real-World Upper-Limb Activity in Nondisabled Adults and Adults With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):969-78. doi: 10.1177/1545968315583720. Epub 2015 Apr 20.
- Jorgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Stoier M, Olsen TS. Outcome and time course of recovery in stroke. Part II: Time course of recovery. The Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 May;76(5):406-12. doi: 10.1016/s0003-9993(95)80568-0.
- Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.
- Han CE, Arbib MA, Schweighofer N. Stroke rehabilitation reaches a threshold. PLoS Comput Biol. 2008 Aug 22;4(8):e1000133. doi: 10.1371/journal.pcbi.1000133.
- Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.
- Stewart JC, Cramer SC. Patient-reported measures provide unique insights into motor function after stroke. Stroke. 2013 Apr;44(4):1111-6. doi: 10.1161/STROKEAHA.111.674671. Epub 2013 Feb 19.
- Stinear CM, Byblow WD. Letter by Stinear and Byblow regarding article, "patient-reported measures provide unique insights into motor function after stroke". Stroke. 2013 Jul;44(7):e79. doi: 10.1161/STROKEAHA.113.001689. Epub 2013 Jun 4. No abstract available.
- Wolfe CD, Crichton SL, Heuschmann PU, McKevitt CJ, Toschke AM, Grieve AP, Rudd AG. Estimates of outcomes up to ten years after stroke: analysis from the prospective South London Stroke Register. PLoS Med. 2011 May;8(5):e1001033. doi: 10.1371/journal.pmed.1001033. Epub 2011 May 17.
- Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-01070
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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