Visual Perception Difficulties After Stroke

July 31, 2023 updated by: Kate Cowen, Durham University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Abingdon, United Kingdom, OX14 1AG
        • Recruiting
        • Abingdon Community Hospital
        • Contact:
      • Bishop Auckland, United Kingdom, DL14 6AD
      • Gateshead, United Kingdom, NE9 6SX

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All testing completed in 2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Durham University

Collaborators

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

Investigators

  • Principal Investigator: Kathleen Vancleef, PhD, Durham University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

September 20, 2024

Study Completion (Estimated)

September 20, 2024

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Durham University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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