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/NCT06015347</url>
    </required_header>
    <id_info>
      <org_study_id>MU-FTR-OK-01</org_study_id>
      <nct_id>NCT06015347</nct_id>
    </id_info>
    <brief_title>The Relationship Between Developmental Level in Infancy and Preschool Motor Performance in Risky Infants</brief_title>
    <official_title>The Relationship Between Motor Development Between 1-18 Months and the Risk of Developmental Coordination Disorder (DCD) in the Preschool Period and Cerebral Palsy (CP) in Risky Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marmara University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Marmara 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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of this study is to evaluate the relationship between the developmental&#xD;
        level between 1-18 months and gross motor performance in the preschool period in risky&#xD;
        infants followed up from a center for early intervention, and to determine the risk of&#xD;
        developmental coordination disorder in the preschool period in risky infants.Gross Motor&#xD;
        Function Measurement-88 will be applied to children diagnosed with cerebral palsy in the&#xD;
        pre-school period to evaluate motor performance, among risky infants evaluated by Alberta&#xD;
        Infant Motor Scale between 1-18 months.&#xD;
  &#xD;
        Developmental Coordination Disorder Questionnaire will be applied to healthy children in&#xD;
        order to evaluate the risk of gross motor performance and developmental coordination&#xD;
        disorder.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Risky infants are at risk in terms of development. Cerebral palsy, mental retardation, visual&#xD;
        and hearing disorders are seen as major neurodevelopmental disorders, developmental&#xD;
        coordination disorder, attention deficit and hyperactivity disorder and learning disability&#xD;
        are seen as minor. In order to detect major and minor disorders that may be seen in the&#xD;
        future, these infants should be evaluated periodically in terms of neurodevelopment from&#xD;
        birth.There are many reliable tests in the neurodevelopmental evaluation of risky infants,&#xD;
        and one of them is the Alberta Infant Motor Scale.&#xD;
  &#xD;
        Alberta Infant Motor Scale (AIMS) assesses motor performance and level of development from&#xD;
        birth to 18 months. AIMS finds a total of 58 items in 4 different positions, and each item is&#xD;
        1 point. The scores obtained in all positions are added together and this score is converted&#xD;
        into a percentile score that shows the baby's status relative to his/her peers. When looking&#xD;
        at the norm chart of AIMS, there are 5%, 10%, 25%, 50%, 75%, and 90% lines. The 5% and 10%&#xD;
        norm lines are used as cutoff lines for abnormal motor development.&#xD;
  &#xD;
        Gross Motor Function Measure-88 is used to evaluate gross motor performance and function&#xD;
        change in children aged 15 months to 13 years with cerebral palsy and Down syndrome. There&#xD;
        are a total of 88 items in 5 categories (supine and prone 17, sitting 20, crawling and&#xD;
        kneeling 14, standing 13, walking, running, and climbing stairs 24). Scoring is done&#xD;
        according to the ability to perform gross motor functions correctly. Scoring is done in the&#xD;
        range of 0 - 3. If he/she starts the activity, 0 points, 1 point if he/she starts the&#xD;
        activity, 2 points if he/she completes the activity partially, and 3 points if he/she&#xD;
        completes the activity independently. Categories and total scores are calculated as a&#xD;
        percentage (%).&#xD;
  &#xD;
        Developmental Coordination Disorder Questionnaire is a 15-item questionnaire used to measure&#xD;
        developmental coordination disorder risk and evaluate motor performance and skills in&#xD;
        children aged 5-15 years. It consists of 15 items. Scoring is between 1 and 5 (1 = not&#xD;
        similar, 5 = very similar). The maximum score that can be obtained from the test is 75. The&#xD;
        range of scores indicating the risk of developmental coordination disorder varies according&#xD;
        to age. 5-7 years - 15-46 points; 8-9 years - 15-55 points; It means that there is a risk of&#xD;
        DCD developmental coordination disorder between the ages of 10-15 - 15-57 points.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Actual">November 30, 2021</completion_date>
    <primary_completion_date type="Actual">August 15, 2021</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Developmental Coordination Disorder Questionnaire</measure>
      <time_frame>4-6 years</time_frame>
      <description>Developmental Coordination Disorder Questionnaire is a 15-item questionnaire used to measure developmental coordination disorder risk and evaluate motor performance and skills in children aged 5-15 years. It consists of 15 items. Scoring is between 1 and 5 (1 = not similar, 5 = very similar). The maximum score that can be obtained from the test is 75. The range of scores indicating the risk of developmental coordination disorder varies according to age. 5-7 years - 15-46 points; 8-9 years - 15-55 points; It means that there is a risk of developmental coordination disorder between the ages of 10-15 - 15-57 points.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gross Motor Function Measure-88</measure>
      <time_frame>4-6 years</time_frame>
      <description>Gross Motor Function Measure-88 is used to evaluate gross motor performance and function change in children aged 15 months to 13 years with cerebral palsy and Down syndrome. There are a total of 88 items in 5 categories (supine and prone 17, sitting 20, crawling and kneeling 14, standing 13, walking, running, and climbing stairs 24). Scoring is done according to the ability to perform gross motor functions correctly. Scoring is done in the range of 0 - 3. If he/she starts the activity, 0 points, 1 point if he/she starts the activity, 2 points if he/she completes the activity partially, and 3 points if he/she completes the activity independently. Categories and total scores are calculated as a percentage (%).</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">57</enrollment>
    <condition>Cerebral Palsy</condition>
    <condition>Developmental Coordination Disorder</condition>
    <arm_group>
      <arm_group_label>Assessment</arm_group_label>
      <description>Infants at risk rated with the Alberta Infant Motor Scale between 1-18 months</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          At-risk infants currently aged 4-6 years and evaluated with the Alberta Infant Motor Scale&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  To take part in the risky baby classification,&#xD;
  &#xD;
            -  Being between the ages of 4-6,&#xD;
  &#xD;
            -  To have been evaluated with the Alberta Infant Motor Scale at the Turkish Spastic&#xD;
               Children Foundation Family Counseling Center,&#xD;
  &#xD;
            -  To agree to participate in the study and to have the informed consent form approved by&#xD;
               the family.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The family does not approve the informed consent form,&#xD;
  &#xD;
            -  Not being evaluated with the Alberta Infant Motor Scale,&#xD;
  &#xD;
            -  Diagnosis of Down syndrome and genetic syndrome,&#xD;
  &#xD;
            -  Being outside the age range,&#xD;
  &#xD;
            -  Currently having a health problem that would prevent assessment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ozge KARANLIK</last_name>
      <role>Principal Investigator</role>
      <affiliation>Marmara University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Turkish Spastic Children Foundation</name>
        <address>
          <city>Istanbul</city>
          <state>Atasehir</state>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Marmara University</investigator_affiliation>
      <investigator_full_name>Ozge Karanlik</investigator_full_name>
      <investigator_title>Msc</investigator_title>
    </responsible_party>
    <keyword>Cerebral Palsy</keyword>
    <keyword>Developmental Coordination Disorder</keyword>
    <keyword>Infant, Premature</keyword>
    <keyword>Child Development</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cerebral Palsy</mesh_term>
      <mesh_term>Motor Skills Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06015347
  org study id: MU-FTR-OK-01
  nct id: NCT06015347
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary purpose of this study is to evaluate the relationship between the developmental
        level between 1-18 months and gross motor performance in the preschool period in risky
        infants followed up from a center for early intervention, and to determine the risk of
        developmental coordination disorder in the preschool period in risky infants.Gross Motor
        Function Measurement-88 will be applied to children diagnosed with cerebral palsy in the
        pre-school period to evaluate motor performance, among risky infants evaluated by Alberta
        Infant Motor Scale between 1-18 months.
  
        Developmental Coordination Disorder Questionnaire will be applied to healthy children in
        order to evaluate the risk of gross motor performance and developmental coordination
        disorder.
  Risky infants are at risk in terms of development. Cerebral palsy, mental retardation, visual
        and hearing disorders are seen as major neurodevelopmental disorders, developmental
        coordination disorder, attention deficit and hyperactivity disorder and learning disability
        are seen as minor. In order to detect major and minor disorders that may be seen in the
        future, these infants should be evaluated periodically in terms of neurodevelopment from
        birth.There are many reliable tests in the neurodevelopmental evaluation of risky infants,
        and one of them is the Alberta Infant Motor Scale.
  
        Alberta Infant Motor Scale (AIMS) assesses motor performance and level of development from
        birth to 18 months. AIMS finds a total of 58 items in 4 different positions, and each item is
        1 point. The scores obtained in all positions are added together and this score is converted
        into a percentile score that shows the baby's status relative to his/her peers. When looking
        at the norm chart of AIMS, there are 5%, 10%, 25%, 50%, 75%, and 90% lines. The 5% and 10%
        norm lines are used as cutoff lines for abnormal motor development.
  
        Gross Motor Function Measure-88 is used to evaluate gross motor performance and function
        change in children aged 15 months to 13 years with cerebral palsy and Down syndrome. There
        are a total of 88 items in 5 categories (supine and prone 17, sitting 20, crawling and
        kneeling 14, standing 13, walking, running, and climbing stairs 24). Scoring is done
        according to the ability to perform gross motor functions correctly. Scoring is done in the
        range of 0 - 3. If he/she starts the activity, 0 points, 1 point if he/she starts the
        activity, 2 points if he/she completes the activity partially, and 3 points if he/she
        completes the activity independently. Categories and total scores are calculated as a
        percentage (%).
  
        Developmental Coordination Disorder Questionnaire is a 15-item questionnaire used to measure
        developmental coordination disorder risk and evaluate motor performance and skills in
        children aged 5-15 years. It consists of 15 items. Scoring is between 1 and 5 (1 = not
        similar, 5 = very similar). The maximum score that can be obtained from the test is 75. The
        range of scores indicating the risk of developmental coordination disorder varies according
        to age. 5-7 years - 15-46 points; 8-9 years - 15-55 points; It means that there is a risk of
        DCD developmental coordination disorder between the ages of 10-15 - 15-57 points.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Developmental Coordination Disorder Questionnaire
  time frame: 4-6 years
  description: Developmental Coordination Disorder Questionnaire is a 15-item questionnaire used to measure developmental coordination disorder risk and evaluate motor performance and skills in children aged 5-15 years. It consists of 15 items. Scoring is between 1 and 5 (1 = not similar, 5 = very similar). The maximum score that can be obtained from the test is 75. The range of scores indicating the risk of developmental coordination disorder varies according to age. 5-7 years - 15-46 points; 8-9 years - 15-55 points; It means that there is a risk of developmental coordination disorder between the ages of 10-15 - 15-57 points.
  measure: Gross Motor Function Measure-88
  time frame: 4-6 years
  description: Gross Motor Function Measure-88 is used to evaluate gross motor performance and function change in children aged 15 months to 13 years with cerebral palsy and Down syndrome. There are a total of 88 items in 5 categories (supine and prone 17, sitting 20, crawling and kneeling 14, standing 13, walking, running, and climbing stairs 24). Scoring is done according to the ability to perform gross motor functions correctly. Scoring is done in the range of 0 - 3. If he/she starts the activity, 0 points, 1 point if he/she starts the activity, 2 points if he/she completes the activity partially, and 3 points if he/she completes the activity independently. Categories and total scores are calculated as a percentage (%).
  arm group label: Assessment
  description: Infants at risk rated with the Alberta Infant Motor Scale between 1-18 months
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 6 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ozge KARANLIK
  role: Principal Investigator
  affiliation: Marmara University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Marmara University
  investigator full name: Ozge Karanlik
  investigator title: Msc
  mesh term: Cerebral Palsy
  mesh term: Motor Skills Disorders