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Predicting Real World Physical Activity and Upper Limb Use After Stroke (REUSE)

25. november 2021 oppdatert av: University of Zurich

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.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

98

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Zurich, Sveits, 8091
        • University Hospital Zurich

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Admitted to hospital

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Assessment of real world performance
Patients will be assessed by using movement sensors and standard clinical assessments

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Daily life assessment of physical activity engagement and upper limb use
Tidsramme: 90 days after stroke onset
Real world performance, measured with movement sensors (number)
90 days after stroke onset

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Neurological impairments
Tidsramme: 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)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb motor function
Tidsramme: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fugl-Meyer Assessment (0-66 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motor function
Tidsramme: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Motricity Index (0-200 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Trunk ability
Tidsramme: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Trunk Control Test (0-100 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Sitting and standing balance
Tidsramme: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Berg Balance Scale (0-56 points, higher scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Walking ability (independence)
Tidsramme: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Functional Ambulation Categories (0-5 points, higher scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Gait speed and cadence (time)
Tidsramme: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Ten-Meter Walk Test
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity
Tidsramme: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Action Research Arm Test (0-56 points, higher scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Upper limb capacity dexterity
Tidsramme: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Box and Block Test (number of blocks)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Global disability
Tidsramme: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Modified Rankin Scale (0-6 points, lower scores being better)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fatigue
Tidsramme: 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Fatigue Severity Scale (9-63 point, lower scores being better)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Cognition
Tidsramme: 3 and 90 days after stroke onset
Montreal Cognitive Assessment(0-30 points, higher scores being better)
3 and 90 days after stroke onset
Neglect
Tidsramme: 3 and 90 days after stroke onset
Apples Test (number)
3 and 90 days after stroke onset
Patient-reported physical activity
Tidsramme: 90 and 365 days after stroke onset
International Physical Activity Questionnaire (3 levels higher levels are better)
90 and 365 days after stroke onset
Patient-reported daily life upper limb use
Tidsramme: 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)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Patient-reported changes
Tidsramme: 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)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Concomitant movement therapy
Tidsramme: 3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Intensity of therapy based on charts (minutes)
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Serious Events and non-serious infections or cardiovascular events
Tidsramme: 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
3, 10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Daily life assessment of physical activity engagement and upper limb use
Tidsramme: 3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
Real world performance, measured with movement sensors (number)
3, 10, 28 (expected rehabilitation discharge) and 365 days after stroke onset
Levels of anxiety and depression
Tidsramme: 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)
10, 28, 90 (expected rehabilitation discharge) and 365 days after stroke onset
Health care costs and loss of income
Tidsramme: 365 days after stroke onset
Health care costs and loss of income in relation to the stroke (CHF)
365 days after stroke onset

Samarbeidspartnere og etterforskere

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Etterforskere

  • Studiestol: Andreas R Luft, Prof. Dr., University of Zurich, University Hospital Zurich

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2018

Primær fullføring (Faktiske)

31. mars 2021

Studiet fullført (Faktiske)

31. mars 2021

Datoer for studieregistrering

Først innsendt

16. april 2018

Først innsendt som oppfylte QC-kriteriene

30. april 2018

Først lagt ut (Faktiske)

11. mai 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. november 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. november 2021

Sist bekreftet

1. november 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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