xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981482</url>
    </required_header>
    <id_info>
      <org_study_id>Durham University</org_study_id>
      <nct_id>NCT05981482</nct_id>
    </id_info>
    <brief_title>Visual Perception Difficulties After Stroke</brief_title>
    <official_title>Accuracy and Utility of the Oxford Visual Perception Screening (OxVPS), a Screening for Visual Perception Difficulties in Stroke Survivors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Durham University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute for Health Research, United Kingdom</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>County Durham and Darlington NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Oxford</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Durham University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn how well the Oxford Visual Perception&#xD;
        Screening (OxVPS) tool can identify stroke survivors with visual perception difficulties.&#xD;
  &#xD;
        The main aim is to determine the accuracy and utility of the OxVPS compared to the current&#xD;
        gold standard assessment in stroke survivors. In other words, how well can the Oxford Visual&#xD;
        Perception Screening tool (OxVPS) identify stroke patients with visual perception problems?&#xD;
  &#xD;
        Participants will completed the OxVPS and the current gold standards visual perception&#xD;
        screening tool.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a non-experimental cross-sectional study. It aims to compare the new screening test&#xD;
        OxVPS to the gold standard tests for visual perception difficulties.&#xD;
  &#xD;
        Patients will be recruited at stroke rehabilitation units at hospitals in the North East of&#xD;
        England and in Oxfordshire.&#xD;
  &#xD;
        Following consent:&#xD;
  &#xD;
          -  Participants will complete the paper version of the Oxford Visual Perception Screen&#xD;
             OxVPS (~15 min).&#xD;
  &#xD;
          -  Participants will complete screening for visual perception problems with a validated&#xD;
             screening tool (~30-120 min).&#xD;
  &#xD;
          -  Participants will complete screening for cognition alterations and sensory vision with&#xD;
             validated screening tools. (~30 min)&#xD;
  &#xD;
          -  Stroke details (time since stroke, severity) and demographic data (age, socio-economic&#xD;
             status) will be collected to evaluated representativeness of the sample.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 20, 2023</start_date>
    <completion_date type="Anticipated">September 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 20, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Validity of OxVPS</measure>
      <time_frame>All testing completed in 2 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reliability of OxVPS</measure>
      <time_frame>2 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Stroke</condition>
    <condition>Visual Perception</condition>
    <arm_group>
      <arm_group_label>Stroke survivors</arm_group_label>
      <description>Individuals who have survived a stroke</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>OxVPS</intervention_name>
      <description>Comparing a new screening tool, the Oxford visual perception screening, to the gold standard, Rivermead Perceptual Battery Assessment.</description>
      <arm_group_label>Stroke survivors</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Stroke survivors on stroke rehabilitation units in the North East of England and&#xD;
          Oxfordshire.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with a clinical diagnosis of stroke (ischemic stroke and/or intracerebral&#xD;
               haemorrhage).&#xD;
  &#xD;
            -  Within 6 weeks of confirmed stroke.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Insufficient understanding of English&#xD;
  &#xD;
            -  Clinical concerns that patient is unable follow simple instructions.&#xD;
  &#xD;
            -  Clinical concerns that patient is unable to concentrate for 15 minutes.&#xD;
  &#xD;
            -  No capacity to provide informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kathleen Vancleef, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Durham University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kate Cowen, PhD</last_name>
      <phone>441913343275</phone>
      <email>kate.cowen@durham.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kathleen Vancleef, PhD</last_name>
      <phone>441913340108</phone>
      <email>kathleen.vancleef@durham.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Abingdon Community Hospital</name>
        <address>
          <city>Abingdon</city>
          <zip>OX14 1AG</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emma Garrett</last_name>
        <phone>441865904922</phone>
        <email>emma.garett@nhs.net</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Bishop Auckland Hospital</name>
        <address>
          <city>Bishop Auckland</city>
          <zip>DL14 6AD</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ami Wilkinson</last_name>
        <phone>441913332515</phone>
        <email>ami.wilkinson@nhs.net</email>
      </contact>
      <contact_backup>
        <last_name>Revin Thomas, MD</last_name>
        <email>revin.thomas@nhs.net</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Queen Elizabeth Hospital</name>
        <address>
          <city>Gateshead</city>
          <zip>NE9 6SX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Beverley McClelland</last_name>
        <phone>441914456760</phone>
        <email>beverleymcclelland@nhs.net</email>
      </contact>
      <contact_backup>
        <last_name>Ruth DaSilva</last_name>
        <phone>441914453903</phone>
        <email>ruth.dasilva@nhs.net</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Durham University</investigator_affiliation>
      <investigator_full_name>Kate Cowen</investigator_full_name>
      <investigator_title>Postdoc researcher</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981482
  org study id: Durham University
  nct id: NCT05981482
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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.
  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.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Validity of OxVPS
  time frame: All testing completed in 2 weeks
  description: 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.
  measure: Reliability of OxVPS
  time frame: 2 weeks
  description: 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.
  arm group label: Stroke survivors
  description: Individuals who have survived a stroke
  intervention type: Diagnostic Test
  intervention name: OxVPS
  description: Comparing a new screening tool, the Oxford visual perception screening, to the gold standard, Rivermead Perceptual Battery Assessment.
  arm group label: Stroke survivors
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kathleen Vancleef, PhD
  role: Principal Investigator
  affiliation: Durham University
  last name: Kate Cowen, PhD
  phone: 441913343275
  email: kate.cowen@durham.ac.uk
  last name: Kathleen Vancleef, PhD
  phone: 441913340108
  email: kathleen.vancleef@durham.ac.uk
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: Durham University
  investigator full name: Kate Cowen
  investigator title: Postdoc researcher
  mesh term: Stroke
  sharing ipd: No