<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/NCT03023579</url>
  </required_header>
  <id_info>
    <org_study_id>DKim</org_study_id>
    <nct_id>NCT03023579</nct_id>
  </id_info>
  <brief_title>The Star Excursion Balance Test: Analysis of Children With Cerebral Palsy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inje University</source>
  <brief_summary>
    <textblock>
      PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM),&#xD;
      and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children&#xD;
      with cerebral palsy (CP).&#xD;
&#xD;
      METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in this&#xD;
      study. Each child carried out the SEBT and was assessed by two examiners. To determine&#xD;
      intra-rater reliability, the investigators calculated the intra-class correlation coefficient&#xD;
      (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to determine the&#xD;
      inter-rater reliability.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The star excursion balance test</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Search MeSH</condition>
  <arm_group>
    <arm_group_label>The star excursion balance test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The star excursion balance test: simple test for dynamic balance</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The star excursion balance test</intervention_name>
    <arm_group_label>The star excursion balance test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  were aged between 4 and 12 years,&#xD;
&#xD;
          -  had a status above level II on the Gross Motor Function Classification System (GMFCS),&#xD;
&#xD;
          -  were able to understand instructions from the rater, and&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had history of fracture or sprain of the lower limbs over the previous 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 14, 2017</last_update_submitted>
  <last_update_submitted_qc>January 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Do hyun Kim</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03023579
org study id: DKim
nct id: NCT03023579
lead sponsor: 
PURPOSE: The investigators estimated the reliability, standard error of measurement (SEM),
      and minimum detectable change (MDC) of the star excursion balance test (SEBT) in children
      with cerebral palsy (CP).

      METHODS: Eight children with CP (four boys and four girls, sixteen legs) participated in this
      study. Each child carried out the SEBT and was assessed by two examiners. To determine
      intra-rater reliability, the investigators calculated the intra-class correlation coefficient
      (ICC) model (3,3). The investigators also calculated the ICC model (2,3) to determine the
      inter-rater reliability.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The star excursion balance test
time frame: 6 months
arm group label: The star excursion balance test
arm group type: Experimental
description: The star excursion balance test: simple test for dynamic balance
intervention type: Other
intervention name: The star excursion balance test
arm group label: The star excursion balance test
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Do hyun Kim
investigator title: Principal Investigator