StrokeNCT05981482
Visual Perception Difficulties After Stroke
An observational study of Stroke and Visual Perception, run by Durham University at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Visual Perception
- What is being tested?
- OxVPS
- How many people
- 200 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 20 Jun 2023to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke survivors on stroke rehabilitation units in the North East of England and Oxfordshire.
Who may be able to join
- Patients with a clinical diagnosis of stroke (ischemic stroke and/or intracerebral haemorrhage).
- Within 6 weeks of confirmed stroke.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
Abingdon Community Hospital
Abingdon, OX14 1AG
Emma Garrett, 441865904922, emma.garett@nhs.net
- Recruiting
Bishop Auckland Hospital
Bishop Auckland, DL14 6AD
Ami Wilkinson, 441913332515, ami.wilkinson@nhs.net
Revin Thomas, MD, revin.thomas@nhs.net
- Recruiting
Queen Elizabeth Hospital
Gateshead, NE9 6SX
Beverley McClelland, 441914456760, beverleymcclelland@nhs.net
Ruth DaSilva, 441914453903, ruth.dasilva@nhs.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Visual Perception
- Being tested
- OxVPS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxVPSDiagnostic test
Comparing a new screening tool, the Oxford visual perception screening, to the gold standard, Rivermead Perceptual Battery Assessment.
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors | Individuals who have survived a stroke Receives: Diagnostic Test: OxVPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start20 Jun 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Durham University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, County Durham and Darlington NHS Foundation Trust, University of Oxford
- Responsible party
- Principal investigator, Kate Cowen, Durham University
- Investigators
- Kathleen Vancleef, PhD, Principal investigator, Durham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981482
- Sponsor's protocol ID
- Durham University
- Status last verified
- Aug 2024
- First submitted
- 31 Jul 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Utility of the Oxford Visual Perception Screening (OxVPS), a Screening for Visual Perception Difficulties in Stroke Survivors
- ClinicalTrials.gov ID
- NCT05981482
- Acronym / sponsor ID
- Durham University
- Conditions
- Stroke, Visual Perception
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Durham UniversityUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, County Durham and Darlington NHS Foundation Trust, University of Oxford
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke survivors | – | Diagnostic Test: OxVPSIndividuals who have survived a stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke survivors on stroke rehabilitation units in the North East of England and Oxfordshire.
Key inclusion criteria (2 listed)
- Patients with a clinical diagnosis of stroke (ischemic stroke and/or intracerebral haemorrhage).
- Within 6 weeks of confirmed stroke.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxVPSComparing a new screening tool, the Oxford visual perception screening, to the gold standard, Rivermead Perceptual Battery Assessment. | Diagnostic test | Stroke survivors |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Vancleef, PhD principal investigator
Durham University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Visual Perception, run by Durham University at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate Cowen, PhD (441913343275, kate.cowen@durham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of OxVPS (time frame: All testing completed in 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.