NCT05981482

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

July 31, 2023

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Validity of OxVPS

    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

    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

Study Arms (1)

Stroke survivors

Individuals who have survived a stroke

Diagnostic Test: OxVPS

Interventions

OxVPSDIAGNOSTIC_TEST

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

Stroke survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke survivors on stroke rehabilitation units in the North East of England and Oxfordshire.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Abingdon Community Hospital

Abingdon, OX14 1AG, United Kingdom

RECRUITING

Bishop Auckland Hospital

Bishop Auckland, DL14 6AD, United Kingdom

RECRUITING

Queen Elizabeth Hospital

Gateshead, NE9 6SX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kathleen Vancleef, PhD

    Durham University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc researcher

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 8, 2023

Study Start

June 20, 2023

Primary Completion

August 31, 2024

Study Completion

February 28, 2026

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations