Evaluation of Stroke Patient Screening
Evaluation of Stroke Patient Screening in an Acute Stroke Setting
Background and Rationale:
Traditionally, stroke rehabilitation studies have been performed in stroke patients beyond the first one to three months poststroke [Stinear et al. 2013; Veerbeek et al. 2014]. Acknowledging that early stroke rehabilitation should be initiated soon after stroke onset to optimize stroke outcomes, it is has been stressed that stroke rehabilitation trials should be initiated within the first month [Stinear 2013].
Early stroke rehabilitation trials face difficulties regarding patient recruitment with corresponding low enrollment rates [AVERT 2015; Winters 2015]. Explanations are for example priority given to (sub)acute medical interventions, highly dynamic situation at a stroke unit, and a more rapid change in patients' abilities when compared to patients in later stages poststroke. With the low enrollment rates (~7%), the generalizability of study results is questionable.
Participant screening methods and procedures for research eligibility are part of the patient selection and recruitment process in clinical trials. However, no information is available regarding screening procedures and methods for these early initiated stroke rehabilitation trials, including reasons for not enrolling patients. This knowledge is essential to improve screening procedures and methods, in order to optimize patient enrollment and with that, increase the generalizability of study results.
Objective:
The objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research.
Study Design:
Observational study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Objective:
The objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research in the Department of Neurology, University Hospital Zurich.
Outcome:
Enrollment rates (defined as the number of patients enrolled per month of recruitment), reasons for non-enrollment, and estimated costs for screening for early stroke rehabilitation studies.
Study Design:
Observational study
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Zurich
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Zürich, Zurich, Sveits, 8091
- Zürcher RehaZentrum Wald
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- First-ever unilateral ischemic stroke <48 hours, confirmed by MRI-DWI and/or CT
- Age 18 years or older
- Able to follow one-staged commands
- NIHSS arm score ≥1
- Informed consent after participants' information
Exclusion Criteria:
- Modified Rankin Scale score >2 before stroke
- Neurological or other diseases affecting the upper limb(s) before stroke
- Intravenous line in the upper limb(s) which limits assessment
- Contra-indications on ethical grounds
- Expected or known non-compliance to participate in the observational study, severe drug or/and alcohol abuse
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Reasons why participants are not eligible for an early rehabilitation trial
Tidsramme: 1 Day
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The reasons for non-enrollment will be measured by counting, based on the inclusion and exclusion criteria of the aRISE study
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1 Day
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Enrolment rate
Tidsramme: 1 Month
|
Defined as the number of patients enrolled per month of screening
|
1 Month
|
|
Estimated personnel expenses in Swiss Francs for screening
Tidsramme: 1 Month
|
Swiss Francs associated with screening in the hospital
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1 Month
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- AVERT Trial Collaboration group. Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial. Lancet. 2015 Jul 4;386(9988):46-55. doi: 10.1016/S0140-6736(15)60690-0. Epub 2015 Apr 16. Erratum In: Lancet. 2015 Jul 4;386(9988):30. Lancet. 2017 May 13;389(10082):1884.
- Stinear C, Ackerley S, Byblow W. Rehabilitation is initiated early after stroke, but most motor rehabilitation trials are not: a systematic review. Stroke. 2013 Jul;44(7):2039-45. doi: 10.1161/STROKEAHA.113.000968. Epub 2013 May 28. No abstract available.
- Winters C, van Wegen EE, Daffertshofer A, Kwakkel G. Generalizability of the Proportional Recovery Model for the Upper Extremity After an Ischemic Stroke. Neurorehabil Neural Repair. 2015 Aug;29(7):614-22. doi: 10.1177/1545968314562115. Epub 2014 Dec 11.
- Held JPO, van Duinen J, Luft AR, Veerbeek JM. Eligibility Screening for an Early Upper Limb Stroke Rehabilitation Study. Front Neurol. 2019 Jul 2;10:683. doi: 10.3389/fneur.2019.00683. eCollection 2019.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Req-2017-00844
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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