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/NCT06033638</url>
    </required_header>
    <id_info>
      <org_study_id>K 2022-10475</org_study_id>
      <nct_id>NCT06033638</nct_id>
    </id_info>
    <brief_title>Video Documented PBS-Score in Children With Clubfoot</brief_title>
    <acronym>PEVA</acronym>
    <official_title>Agreement and Inter-rater Reliability of Video Documented PBS-Score - An International Cross-sectional Multicenter Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Stockholm</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Region Stockholm</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Evaluate agreement and inter-rater reliability of PBS-score assessments based on video&#xD;
        documented material.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        120 children with idiopathic clubfoot will be included from four different countries 30&#xD;
        patients from each participating center. Inclusion criteria include: age 4-14 years,&#xD;
        diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate&#xD;
        verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto.&#xD;
        All items of the PBS-score will be documented using video recordings. Six to eight senior&#xD;
        orthopedic surgeons will score a total of 90 children each, not the children from their&#xD;
        center of employment, according to the PBS-score based on videos. Collaborating centers&#xD;
        include Karolinska University Hospital, Sweden, Hospital Pequeno Príncipe, Brazil, and&#xD;
        Hayatabad Medical Complex, Orthopaedic Unit, Peshawar, Pakistan.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 12, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>PBS Score agreement and inter-rater reliability</measure>
      <time_frame>1 year</time_frame>
      <description>PBS Score is a tool to grade the severity of clubfoot recurrence in the walking child, and was proposed to serve as an instrument to guide treatment. The sum of all points for all signs is scored between 7 and 18.</description>
    </primary_outcome>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Clubfoot</condition>
    <condition>PBS</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Score assessment</intervention_name>
      <description>PBS Score</description>
      <other_name>PBS-score, video evaluation, PROM</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children born with clubfoot&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clubfoot&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eva W Broström, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Astrid Lindgren Children´s Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Josefine E Naili, PhD</last_name>
      <phone>+46 123 000 00</phone>
      <email>josefine.naili@ki.se</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eva W Broström, Professor</last_name>
      <phone>+46 7002 1670</phone>
      <email>eva.brostrom@ki.se</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Astrid Lindgren Children´s Hospital</name>
        <address>
          <city>Stockholm</city>
          <state>Region Stockholm</state>
          <zip>17176</zip>
          <country>Sweden</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eva W Broström</last_name>
        <phone>+4670021670</phone>
        <email>eva.brostrom@ki.se</email>
      </contact>
      <contact_backup>
        <last_name>Josefine E Naili</last_name>
        <phone>+4612300000</phone>
        <email>josefine.naili@ki.se</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Region Stockholm</investigator_affiliation>
      <investigator_full_name>Eva Weidenhielm-Brostrom</investigator_full_name>
      <investigator_title>Manager</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Clubfoot</mesh_term>
      <mesh_term>Talipes</mesh_term>
      <mesh_term>Equinus Deformity</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/NCT06033638
  org study id: K 2022-10475
  nct id: NCT06033638
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Evaluate agreement and inter-rater reliability of PBS-score assessments based on video
        documented material.
  120 children with idiopathic clubfoot will be included from four different countries 30
        patients from each participating center. Inclusion criteria include: age 4-14 years,
        diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate
        verbally (and in writing for caregivers) in Swedish, English, Portuguese, Urdu, or Pashto.
        All items of the PBS-score will be documented using video recordings. Six to eight senior
        orthopedic surgeons will score a total of 90 children each, not the children from their
        center of employment, according to the PBS-score based on videos. Collaborating centers
        include Karolinska University Hospital, Sweden, Hospital Pequeno Príncipe, Brazil, and
        Hayatabad Medical Complex, Orthopaedic Unit, Peshawar, Pakistan.
  observational model: Cohort
  time perspective: Prospective
  measure: PBS Score agreement and inter-rater reliability
  time frame: 1 year
  description: PBS Score is a tool to grade the severity of clubfoot recurrence in the walking child, and was proposed to serve as an instrument to guide treatment. The sum of all points for all signs is scored between 7 and 18.
  intervention type: Other
  intervention name: Score assessment
  description: PBS Score
  other name: PBS-score, video evaluation, PROM
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 17 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Eva W Broström, Professor
  role: Principal Investigator
  affiliation: Astrid Lindgren Children´s Hospital
  last name: Josefine E Naili, PhD
  phone: +46 123 000 00
  email: josefine.naili@ki.se
  last name: Eva W Broström, Professor
  phone: +46 7002 1670
  email: eva.brostrom@ki.se
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Region Stockholm
  investigator full name: Eva Weidenhielm-Brostrom
  investigator title: Manager
  mesh term: Clubfoot
  mesh term: Talipes
  mesh term: Equinus Deformity
  sharing ipd: No