Visual Perception Difficulties After Stroke

Sponsor

Durham University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05981482

Collaborator

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

200

Enrollment

Locations

Anticipated Duration (Months)

66.7

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Jun 20, 2023

Anticipated Primary Completion Date :

Sep 20, 2024

Anticipated Study Completion Date :

Sep 20, 2024

Arms and Interventions

Arm	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.

Arm

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

Primary Outcome Measures

Validity of OxVPS [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.
Reliability of OxVPS [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Abingdon Community Hospital	Abingdon	United Kingdom	OX14 1AG
2	Bishop Auckland Hospital	Bishop Auckland	United Kingdom	DL14 6AD
3	Queen Elizabeth Hospital	Gateshead	United Kingdom	NE9 6SX

Sponsors and Collaborators

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

Investigators

Principal Investigator: Kathleen Vancleef, PhD, Durham University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kate Cowen, Postdoc researcher, Durham University

ClinicalTrials.gov Identifier:

NCT05981482

Other Study ID Numbers:

Durham University

First Posted:

Aug 8, 2023

Last Update Posted:

Aug 8, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Aug 8, 2023