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NCT Number: NCT05981482

Visual Perception Difficulties After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases Visual Perception

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abingdon Community Hospital, Abingdon, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

OxVPS

Diagnostic Test

Comparing a new screening tool, the Oxford visual perception screening, to the gold standard, Rivermead Perceptual Battery Assessment.

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Cowen, PhD

CONTACT

[email protected]

441913343275

Kathleen Vancleef, PhD

CONTACT

[email protected]

441913340108

Sponsors and collaborators

Lead sponsor

Durham University

Other

Collaborators

  • County Durham and Darlington NHS Foundation Trust
  • National Institute for Health Research, United Kingdom
  • University of Oxford

Registry information

Official study title

Accuracy and Utility of the Oxford Visual Perception Screening (OxVPS), a Screening for Visual Perception Difficulties in Stroke Survivors

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Aug 8, 2023
Registry last updated
Aug 6, 2024

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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