Evaluation of Stroke Patient Screening

Completed

• Conditions: Stroke, Acute

• Registration Number: NCT03633422
• Lead Sponsor: University of Zurich

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2017-09-25
• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 845

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reasons why participants are not eligible for an early rehabilitation trial	1 Day	The reasons for non-enrollment will be measured by counting, based on the inclusion and exclusion criteria of the aRISE study

Secondary Outcome Measures

Name	Time	Method
Enrolment rate	1 Month	Defined as the number of patients enrolled per month of screening
Estimated personnel expenses in Swiss Francs for screening	1 Month	Swiss Francs associated with screening in the hospital

Trial Locations

Locations (1)

Zürcher RehaZentrum Wald; 🇨🇭 Zürich, Zurich, Switzerland