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/NCT05990608</url>
    </required_header>
    <id_info>
      <org_study_id>2021/371</org_study_id>
      <nct_id>NCT05990608</nct_id>
    </id_info>
    <brief_title>Peabody Developmental Motor Scaling In Children With Period Duchenne Muscular Dystrophy</brief_title>
    <official_title>The Validity and Reliability of The Peabody Developmental Motor Score In Children With Preschool Duchenne Muscular Dystrophy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ondokuz Mayıs University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ondokuz Mayıs University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        To perform the reliability and validity study of the Peabody Developmental Motor Scale&#xD;
        (Peabody Developmental Motor Scales-2) in children with Duchenne Muscular Dystrophy (DMD).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 30, 2021</start_date>
    <completion_date type="Actual">July 30, 2023</completion_date>
    <primary_completion_date type="Actual">July 30, 2022</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Peabody Developmental Motor Scales-2</measure>
      <time_frame>This assessment will take place over the course of the study started and to the finish time</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">48</enrollment>
    <condition>Duchenne Muscular Dystrophy (DMD)</condition>
    <arm_group>
      <arm_group_label>Group I</arm_group_label>
      <description>Healthy Children</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II</arm_group_label>
      <description>Children with DMD</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Peabody Developmental Motor Scales-2, PDMS</intervention_name>
      <description>The Peabody Developmental Engine Scales-2, PDMS, is a standardized norm-referenced test used to determine the motor skill level of children aged 0 to 6, identify delays in engine development, and determine individual needs and challenges. The 2 scalar, which allows children to evaluate rough and thin motor skills, consists of 6 sub-tests and 249 articles. The rough motor scale contains 4 sub-tests and 151 items, including reflex, equilibrium, locomotion and object manipulation. The slim motor scale consists of 2 sub-tests and 98 items, including cognition and visual-motor integration. Using the age-appropriate normal value ranges in the test manual to determine developmental stress risk and level, the coarse motor skills, slim motor skills, and general motor development are categorized as &quot;very low, low, below average, above average, high, very high&quot;.</description>
      <arm_group_label>Group I</arm_group_label>
      <arm_group_label>Group II</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Ondokuz Mayıs University, Health Application and Research Center, Pediatric Neurology&#xD;
          Outpatient Clinic and community samples&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  for Group I:&#xD;
  &#xD;
                 -  No neurodevelopmental problems or diseases&#xD;
  &#xD;
                 -  3-5 years old&#xD;
  &#xD;
                 -  Being able to cooperate with the instructions given by the physiotherapist.&#xD;
  &#xD;
                 -  Children who volunteered to participate in the study and whose families gave&#xD;
                    consent form will be included in the study.&#xD;
  &#xD;
            -  for Group II:&#xD;
  &#xD;
                 -  Being diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist&#xD;
  &#xD;
                 -  3-5 years old&#xD;
  &#xD;
                 -  Children who volunteered to participate in the study and whose parents' consent&#xD;
                    was obtained will be included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with a behavioral condition and any disorder that interferes with testing (eg&#xD;
               autism spectrum disorder)&#xD;
  &#xD;
            -  Failure to cooperate with the physiotherapist who made the evaluations.&#xD;
  &#xD;
            -  Lack of volunteers.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>5 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Deniz Çakır</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ondokuz Mayıs University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ondokuz Mayıs University</name>
        <address>
          <city>Samsun</city>
          <zip>55270</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ondokuz Mayıs University</investigator_affiliation>
      <investigator_full_name>Deniz Çakır</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>Duchenne Muscular Dystrophy (DMD)</keyword>
    <keyword>Peabody Developmental Motor Scales-2</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Muscular Dystrophies</mesh_term>
      <mesh_term>Muscular Dystrophy, Duchenne</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/NCT05990608
  org study id: 2021/371
  nct id: NCT05990608
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To perform the reliability and validity study of the Peabody Developmental Motor Scale
        (Peabody Developmental Motor Scales-2) in children with Duchenne Muscular Dystrophy (DMD).
  observational model: Other
  time perspective: Other
  measure: Peabody Developmental Motor Scales-2
  time frame: This assessment will take place over the course of the study started and to the finish time
  arm group label: Group I
  description: Healthy Children
  arm group label: Group II
  description: Children with DMD
  intervention type: Other
  intervention name: Peabody Developmental Motor Scales-2, PDMS
  description: The Peabody Developmental Engine Scales-2, PDMS, is a standardized norm-referenced test used to determine the motor skill level of children aged 0 to 6, identify delays in engine development, and determine individual needs and challenges. The 2 scalar, which allows children to evaluate rough and thin motor skills, consists of 6 sub-tests and 249 articles. The rough motor scale contains 4 sub-tests and 151 items, including reflex, equilibrium, locomotion and object manipulation. The slim motor scale consists of 2 sub-tests and 98 items, including cognition and visual-motor integration. Using the age-appropriate normal value ranges in the test manual to determine developmental stress risk and level, the coarse motor skills, slim motor skills, and general motor development are categorized as "very low, low, below average, above average, high, very high".
  arm group label: Group I
  arm group label: Group II
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 5 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Deniz Çakır
  role: Principal Investigator
  affiliation: Ondokuz Mayıs University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ondokuz Mayıs University
  investigator full name: Deniz Çakır
  investigator title: Research Assistant
  mesh term: Muscular Dystrophies
  mesh term: Muscular Dystrophy, Duchenne
  sharing ipd: No