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Visual Perception Difficulties After Stroke

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ClinicalTrials.gov Identifier: NCT05981482
Recruitment Status : Recruiting
First Posted : August 8, 2023
Last Update Posted : August 8, 2023
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
County Durham and Darlington NHS Foundation Trust
University of Oxford
Information provided by (Responsible Party):
Kate Cowen, Durham University

Study Description
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Brief Summary:

The goal of this observational study is to learn how well the Oxford Visual Perception Screening (OxVPS) tool can identify stroke survivors with visual perception difficulties.

The main aim is to determine the accuracy and utility of the OxVPS compared to the current gold standard assessment in stroke survivors. In other words, how well can the Oxford Visual Perception Screening tool (OxVPS) identify stroke patients with visual perception problems?

Participants will completed the OxVPS and the current gold standards visual perception screening tool.


Condition or disease Intervention/treatment
Stroke Visual Perception Diagnostic Test: OxVPS

Detailed Description:

This is a non-experimental cross-sectional study. It aims to compare the new screening test OxVPS to the gold standard tests for visual perception difficulties.

Patients will be recruited at stroke rehabilitation units at hospitals in the North East of England and in Oxfordshire.

Following consent:

  • Participants will complete the paper version of the Oxford Visual Perception Screen OxVPS (~15 min).
  • Participants will complete screening for visual perception problems with a validated screening tool (~30-120 min).
  • Participants will complete screening for cognition alterations and sensory vision with validated screening tools. (~30 min)
  • Stroke details (time since stroke, severity) and demographic data (age, socio-economic status) will be collected to evaluated representativeness of the sample.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Accuracy and Utility of the Oxford Visual Perception Screening (OxVPS), a Screening for Visual Perception Difficulties in Stroke Survivors
Actual Study Start Date : June 20, 2023
Estimated Primary Completion Date : September 20, 2024
Estimated Study Completion Date : September 20, 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Stroke survivors
Individuals who have survived a stroke
 Diagnostic Test: OxVPS
Comparing a new screening tool, the Oxford visual perception screening, to the gold standard, Rivermead Perceptual Battery Assessment.


Outcome Measures
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Primary Outcome Measures :
  1. Validity of OxVPS [ Time Frame: All testing completed in 2 weeks ]
    Convergent and discriminate validity will be assessed. Convergent validity expressed as a correlation between total score on OxVPS and RPAB. Discriminate validity to be expressed as correlation between OxVPS score and scores of cognitive and sensory vision assessments. Both calculated by a non-parametric Spearman correlation and estimate a 95% confidence interval. The analysis can be completed through the cor.test function in the base package of R.

  2. Reliability of OxVPS [ Time Frame: 2 weeks ]
    The inter-rater reliability of OxVPS will be evaluated through a Bland-Altman analysis [26]: we will calculate the difference in OxVPS scores between raters for each patient. Subsequently, we will plot the difference in scores as a function on the average score to evaluate a bias between the raters (mean difference) that might vary based on severity of a patient's visual perceptual problems. We will report the mean difference, standard deviation, and limits of agreement within where 95% of differences between raters fall. A t-test will indicate if the mean difference is significantly different from 0. Analyses will be performed in R with the functions from blandr package (e.g. blandr.statistics and blandr.draw) or functions from a similar package.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stroke survivors on stroke rehabilitation units in the North East of England and Oxfordshire.
Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of stroke (ischemic stroke and/or intracerebral haemorrhage).
  • Within 6 weeks of confirmed stroke.

Exclusion Criteria:

  • Insufficient understanding of English
  • Clinical concerns that patient is unable follow simple instructions.
  • Clinical concerns that patient is unable to concentrate for 15 minutes.
  • No capacity to provide informed consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05981482


Contacts
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Contact: Kate Cowen, PhD 441913343275 kate.cowen@durham.ac.uk
Contact: Kathleen Vancleef, PhD 441913340108 kathleen.vancleef@durham.ac.uk

Locations
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United Kingdom
Abingdon Community Hospital Recruiting
Abingdon, United Kingdom, OX14 1AG
Contact: Emma Garrett    441865904922    emma.garett@nhs.net   
Bishop Auckland Hospital Recruiting
Bishop Auckland, United Kingdom, DL14 6AD
Contact: Ami Wilkinson    441913332515    ami.wilkinson@nhs.net   
Contact: Revin Thomas, MD       revin.thomas@nhs.net   
Queen Elizabeth Hospital Recruiting
Gateshead, United Kingdom, NE9 6SX
Contact: Beverley McClelland    441914456760    beverleymcclelland@nhs.net   
Contact: Ruth DaSilva    441914453903    ruth.dasilva@nhs.net   
Sponsors and Collaborators
Durham University
National Institute for Health Research, United Kingdom
County Durham and Darlington NHS Foundation Trust
University of Oxford
Investigators
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Principal Investigator: Kathleen Vancleef, PhD Durham University
More Information
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Responsible Party: Kate Cowen, Postdoc researcher, Durham University
ClinicalTrials.gov Identifier: NCT05981482    
Other Study ID Numbers: Durham University
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases