Clinical trial NCT03522519: Predicting Real World Physical Activity and Upper Limb Use After Stroke
Official title: Profiling and Predicting the Natural Course of Real World Physical Activity and Upper Limb Use After Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Physical Activity
Upper Extremity
Movement Sensors
Prognosis
Observational Cohort Study
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted to hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: Daily life assessment of physical activity engagement and upper limb use
timeFrame: 90 days after stroke onset
Secondary outcomes:
measure: Neurological impairments
timeFrame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Upper limb motor function
timeFrame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Motor function
timeFrame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Trunk ability
timeFrame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Sitting and standing balance
timeFrame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Walking ability (independence)
timeFrame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Gait speed and cadence (time)
timeFrame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Upper limb capacity
timeFrame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Upper limb capacity dexterity
timeFrame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Global disability
timeFrame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Fatigue
timeFrame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Cognition
timeFrame: 3 and 90 days after stroke onset
measure: Neglect
timeFrame: 3 and 90 days after stroke onset
measure: Patient-reported physical activity
timeFrame: 90 and 365 days after stroke onset
measure: Patient-reported daily life upper limb use
timeFrame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Patient-reported changes
timeFrame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Concomitant movement therapy
timeFrame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Serious Events and non-serious infections or cardiovascular events
timeFrame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Daily life assessment of physical activity engagement and upper limb use
timeFrame: 3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Levels of anxiety and depression
timeFrame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
measure: Health care costs and loss of income
timeFrame: 365 days after stroke onset
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich, University Hospital Zurich
name: Andreas R Luft, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
citation: 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.
citation: 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.
citation: 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.
citation: Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56.
citation: 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.
citation: 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.
citation: 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.