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Completed

NCT Number: NCT03522519

Predicting 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real world performance of physical activity and arm use

Behavioral

Patients will be assessed by using movement sensors and standard clinical assessments

Primary outcomes

  1. Daily life assessment of physical activity engagement and upper limb use

    Time frame: 90 days after stroke onset

    Real world performance, measured with movement sensors (number)

Secondary outcomes

  1. Neurological impairments

    Time frame: 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)

  2. Upper limb motor function

    Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Fugl-Meyer Assessment (0-66 points, higher scores being better)

  3. Motor function

    Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Motricity Index (0-200 points, higher scores being better)

  4. Trunk ability

    Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Trunk Control Test (0-100 points, higher scores being better)

  5. Sitting and standing balance

    Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Berg Balance Scale (0-56 points, higher scores being better)

  6. Walking ability (independence)

    Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Functional Ambulation Categories (0-5 points, higher scores being better)

  7. Gait speed and cadence (time)

    Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Ten-Meter Walk Test

  8. Upper limb capacity

    Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Action Research Arm Test (0-56 points, higher scores being better)

  9. Upper limb capacity dexterity

    Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Box and Block Test (number of blocks)

  10. Global disability

    Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Modified Rankin Scale (0-6 points, lower scores being better)

  11. Fatigue

    Time frame: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Fatigue Severity Scale (9-63 point, lower scores being better)

  12. Cognition

    Time frame: 3 and 90 days after stroke onset

    Montreal Cognitive Assessment(0-30 points, higher scores being better)

  13. Neglect

    Time frame: 3 and 90 days after stroke onset

    Apples Test (number)

  14. Patient-reported physical activity

    Time frame: 90 and 365 days after stroke onset

    International Physical Activity Questionnaire (3 levels higher levels are better)

  15. Patient-reported daily life upper limb use

    Time frame: 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)

  16. Patient-reported changes

    Time frame: 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)

  17. Concomitant movement therapy

    Time frame: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset

    Intensity of therapy based on charts (minutes)

  18. Serious Events and non-serious infections or cardiovascular events

    Time frame: 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

  19. 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

    Real world performance, measured with movement sensors (number)

  20. Levels of anxiety and depression

    Time frame: 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)

  21. Health care costs and loss of income

    Time frame: 365 days after stroke onset

    Health care costs and loss of income in relation to the stroke (CHF)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: REUSE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 11, 2018
Registry last updated
Nov 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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