<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/NCT03777995</url>
  </required_header>
  <id_info>
    <org_study_id>ETK00-2018-0204</org_study_id>
    <nct_id>NCT03777995</nct_id>
  </id_info>
  <brief_title>A New Designed Balance Platform for Children</brief_title>
  <official_title>Reliability and Validity of a New Designed Balance Platform for Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Mediterranean University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eastern Mediterranean University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      People always come across with different floors which gradually affect dynamic balance.&#xD;
      Dynamic balance is important in activities of daily life of all people. There are various&#xD;
      reliable and valid tests for both children and adults, but no test design which includes&#xD;
      different floor materials has been developed. Thus, this study aimed to describe a new&#xD;
      designed balance test platform and investigate its reliability and validity in 3-5 years old&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children whose families signed consent form will be included. Height and weight will be&#xD;
      measured. Then they will be taken to the balance measurements. Design will firstly be shown&#xD;
      to child and one trial will be permitted before starting the test. Timed-up and Go test will&#xD;
      also be used as a reliable and valid test for dynamic balance in this age group. Single leg&#xD;
      standing will also be used to investigate the discrimination feature of the dynamic balance&#xD;
      tested by new design platform.&#xD;
&#xD;
      All tests will be done without socks and shoes. Timing will be the only results for all&#xD;
      tests. Calibrated chronometers will be used for this aim. After all measurements complete,&#xD;
      statistical analysis will be conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Actual">April 10, 2019</completion_date>
  <primary_completion_date type="Actual">March 10, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>New designed test</measure>
    <time_frame>at baseline</time_frame>
    <description>This is a walking platform which has different floor materials</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timed-up and go test</measure>
    <time_frame>at baseline</time_frame>
    <description>This is a reliable and valid test which is used to assess dynamic balance in children. There is a three meter pathway. Two chairs are used for the starting point and to specify the returning point. The test will be repeated 3 times and the best completion time will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single leg standing</measure>
    <time_frame>at baseline</time_frame>
    <description>Children are asked to stand on dominant leg. Their standing duration will be recorded.</description>
  </secondary_outcome>
  <enrollment type="Actual">108</enrollment>
  <condition>Child Development</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children who have a typical development will be recruited from various kindergartens in&#xD;
        Cyprus.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chid aged 3-5 years (birth date: December 2013 - December 2015)&#xD;
&#xD;
          -  Parents who signed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who have problem about musculoskeletal system, neurological disorder,&#xD;
             vestibular system disorders.&#xD;
&#xD;
          -  Children who mention painful situations which may possibly prevent to walk on the&#xD;
             platform&#xD;
&#xD;
          -  Children who have visual problems&#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>ZEHRA GÜÇHAN TOPCU</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Mediterranean University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zehra Güçhan Topcu</name>
      <address>
        <city>Famagusta</city>
        <zip>99628</zip>
        <country>Cyprus</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cyprus</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>October 22, 2019</last_update_submitted>
  <last_update_submitted_qc>October 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Balance</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03777995
org study id: ETK00-2018-0204
nct id: NCT03777995
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
People always come across with different floors which gradually affect dynamic balance.
      Dynamic balance is important in activities of daily life of all people. There are various
      reliable and valid tests for both children and adults, but no test design which includes
      different floor materials has been developed. Thus, this study aimed to describe a new
      designed balance test platform and investigate its reliability and validity in 3-5 years old
      children.
Children whose families signed consent form will be included. Height and weight will be
      measured. Then they will be taken to the balance measurements. Design will firstly be shown
      to child and one trial will be permitted before starting the test. Timed-up and Go test will
      also be used as a reliable and valid test for dynamic balance in this age group. Single leg
      standing will also be used to investigate the discrimination feature of the dynamic balance
      tested by new design platform.

      All tests will be done without socks and shoes. Timing will be the only results for all
      tests. Calibrated chronometers will be used for this aim. After all measurements complete,
      statistical analysis will be conducted.
observational model: Cohort
time perspective: Cross-Sectional
measure: New designed test
time frame: at baseline
description: This is a walking platform which has different floor materials
measure: Timed-up and go test
time frame: at baseline
description: This is a reliable and valid test which is used to assess dynamic balance in children. There is a three meter pathway. Two chairs are used for the starting point and to specify the returning point. The test will be repeated 3 times and the best completion time will be recorded.
measure: Single leg standing
time frame: at baseline
description: Children are asked to stand on dominant leg. Their standing duration will be recorded.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ZEHRA GÜÇHAN TOPCU
role: Principal Investigator
affiliation: Eastern Mediterranean University
facility: 
country: Cyprus
responsible party type: Sponsor