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Completed

NCT Number: NCT03633422

Evaluation of Stroke Patient Screening

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

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zürcher RehaZentrum Wald

Zurich, Canton of Zurich, 8091, Switzerland

About this 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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Reasons why participants are not eligible for an early rehabilitation trial

    Time frame: 1 Day

    The reasons for non-enrollment will be measured by counting, based on the inclusion and exclusion criteria of the aRISE study

Secondary outcomes

  1. Enrolment rate

    Time frame: 1 Month

    Defined as the number of patients enrolled per month of screening

  2. Estimated personnel expenses in Swiss Francs for screening

    Time frame: 1 Month

    Swiss Francs associated with screening in the hospital

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Evaluation of Stroke Patient Screening in an Acute Stroke Setting

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2018
Registry last updated
Feb 7, 2020

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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