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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
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
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| Measure | Description | Time Frame |
|---|---|---|
| Reasons why participants are not eligible for an early rehabilitation trial | The reasons for non-enrollment will be measured by counting, based on the inclusion and exclusion criteria of the aRISE study | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Enrolment rate | Defined as the number of patients enrolled per month of screening | 1 Month |
| Estimated personnel expenses in Swiss Francs for screening | Swiss Francs associated with screening in the hospital |
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Inclusion Criteria:
Exclusion Criteria:
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All stroke patients admitted to the University Hospital Zurich, Department of Neurology, Switzerland.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zürcher RehaZentrum Wald | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25892679 | Background | 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. | |
| 23715959 | Background | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 1 Month |
| 24505342 | Background | 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. |
| 25505223 | Background | 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. |
| 31312170 | Result | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |