Predicting Real World Physical Activity and Upper Limb Use After Stroke

Stroke Clinical Trial

— REUSE  

Official title:

Profiling and Predicting the Natural Course of Real World Physical Activity and Upper Limb Use After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522519
• Other study ID #: 2017-01070
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: November 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Real world performance of physical activity and arm use
Patients will be assessed by using movement sensors and standard clinical assessments

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

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. — View 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. — View Citation

Jørgensen HS, Nakayama H, Raaschou HO, Vive-Larsen J, Støier 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Noorkõiv 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. Review. — View 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. — View 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. — View Citation

Taub E, Uswatte G, Mark VW, Morris DM. The learned nonuse phenomenon: implications for rehabilitation. Eura Medicophys. 2006 Sep;42(3):241-56. Review. — View 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. Review. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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