Evaluation of Stroke Patient Screening

NCT03633422 | Completed

• 1 other identifier: Req-2017-00844
• Study Type: observational
• Target: 845
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke, Acute

Keywords

Rehabilitation; Screening; Enrollment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Enrolment rate

  1 Month

• Estimated personnel expenses in Swiss Francs for screening

  1 Month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All stroke patients admitted to the University Hospital Zurich, Department of Neurology, Switzerland.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Zürcher RehaZentrum Wald

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 25892679 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.

  PMID: 23715959 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.

  PMID: 24505342 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.

  PMID: 25505223 BACKGROUND

• 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.

  PMID: 31312170 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 16, 2018
• Study Start: September 25, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)