AzTrials
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Stroke, AcuteNCT03633422

Evaluation of Stroke Patient Screening

An observational study of Stroke, Acute, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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]. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute
How many people
845 participants
Where
1 siteSwitzerland
Study dates
25 Sep 2017to 31 Jul 2019
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Zürcher RehaZentrum Wald

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: 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].

Read more

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

Read the 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

Conditions
Stroke, Acute
Keywords
Rehabilitation, Screening, Enrollment
Medical subject headings
Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 Day

Secondary outcomes (2)

  1. Enrolment rate

    Defined as the number of patients enrolled per month of screening

    Measured: 1 Month

  2. Estimated personnel expenses in Swiss Francs for screening

    Swiss Francs associated with screening in the hospital

    Measured: 1 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2018
  2. Study start25 Sep 2017
  3. Primary completion31 Jul 2019
  4. Study completion31 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
845 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03633422
Sponsor's protocol ID
Req-2017-00844
Status last verified
Jan 2020
First submitted
24 Jul 2018
Last updated
7 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25892679

  • 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.

    PubMed 23715959

  • 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.

    PubMed 24505342

  • 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.

    PubMed 25505223

  • 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.

    PubMed 31312170

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, Acute, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reasons why participants are not eligible for an early rehabilitation trial (time frame: 1 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03633422, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2020.

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