Predicting Real World Physical Activity and Upper Limb Use After Stroke
NCT ID: NCT03522519
Last Updated: 2021-11-29
Study Results
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Basic Information
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COMPLETED
98 participants
OBSERVATIONAL
2018-09-01
2021-03-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Assessment of real world performance
Real world performance of physical activity and arm use
Patients will be assessed by using movement sensors and standard clinical assessments
Interventions
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Real world performance of physical activity and arm use
Patients will be assessed by using movement sensors and standard clinical assessments
Eligibility Criteria
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Inclusion Criteria
* 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
* Neurological or other diseases affecting upper limb use and/ or physical activity before stroke
* Known or suspected non-compliance, drug or alcohol abuse
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Andreas R Luft, Prof. Dr.
Role: STUDY_CHAIR
University of Zurich, University Hospital Zurich
Locations
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University Hospital Zurich
Zurich, , Switzerland
Countries
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References
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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.
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.
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.
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.
Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
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.
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.
Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.
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.
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.
Pohl J, Verheyden G, Held JPO, Luft AR, Easthope Awai C, Veerbeek JM. Construct validity and responsiveness of clinical upper limb measures and sensor-based arm use within the first year after stroke: a longitudinal cohort study. J Neuroeng Rehabil. 2025 Jan 29;22(1):14. doi: 10.1186/s12984-024-01512-9.
Other Identifiers
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2017-01070
Identifier Type: -
Identifier Source: org_study_id