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/NCT06025656</url>
    </required_header>
    <id_info>
      <org_study_id>2023-942</org_study_id>
      <nct_id>NCT06025656</nct_id>
    </id_info>
    <brief_title>Assessment of the Reliability and Validity of the Leg Lateral Reach Test in Adolescent Tennis Players</brief_title>
    <official_title>Assessment of the Reliability and Validity of the Leg Lateral Reach Test to Measure Thoraco-Lumbo-Pelvic Rotation in Adolescent Tennis Players</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gazi University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gazi 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 aim of this study is to evaluate the reliability and validity of the Leg Lateral Reach&#xD;
        Test to measure thoraco-lumbo-pelvic segment mobility in adolescent tennis players. The fact&#xD;
        that the test is valid and reliable for tennis players will contribute to monitoring trunk&#xD;
        rotation flexibility in athletes, comparing them bilaterally, and revealing the exercise&#xD;
        training necessary to improve performance.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Tennis is a sport characterized by coordinated, repetitive, and rotational movements along&#xD;
        the kinetic chain. Ineffective use of the trunk segment to generate rotational momentum is&#xD;
        thought to increase the load on the upper extremity. Limited trunk rotation flexibility can&#xD;
        cause abnormal trunk motion patterns, resulting in lower back injuries and pain as well as&#xD;
        upper extremity injuries in throwing athletes. Therefore, assessment of trunk flexibility in&#xD;
        athletes who perform repetitive trunk rotations, such as tennis players, is critical for&#xD;
        effective rehabilitation and prevention of sports injuries.&#xD;
  &#xD;
        The Leg Lateral Reach Test was developed to measure the rotation of the thoraco-lumbo-pelvic&#xD;
        segment and was found to be valid and reliable in physically active, healthy individuals.&#xD;
        Therefore, the aim of this study is to evaluate the reliability and validity of the Leg&#xD;
        Lateral Reach Test to measure thoraco-lumbo-pelvic segment mobility in adolescent tennis&#xD;
        players. The fact that the test is valid and reliable for tennis players will contribute to&#xD;
        monitoring trunk rotation flexibility in athletes, comparing them bilaterally, and revealing&#xD;
        the exercise training necessary to improve performance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 15, 2023</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>Sequential Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Leg Lateral Reach Test-1</measure>
      <time_frame>first day</time_frame>
      <description>The leg lateral reach test will be measured by the first investigator.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Leg Lateral Reach Test-2</measure>
      <time_frame>first day</time_frame>
      <description>The leg lateral reach test will be measured by the second investigator.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Leg Lateral Reach Test-3</measure>
      <time_frame>5-7 days after</time_frame>
      <description>The leg lateral reach test will be measured by the first investigator.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Leg Lateral Reach Test-4</measure>
      <time_frame>5-7 days after</time_frame>
      <description>The leg lateral reach test will be measured by the second investigator.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Seated Rotation Test</measure>
      <time_frame>first day</time_frame>
      <description>A seated rotation test will be measured for validity analysis.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Trunk Injury</condition>
    <condition>Mobility Limitation</condition>
    <condition>Spine Injury</condition>
    <condition>Athletic Injuries</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>adolescent tennis player</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Leg Lateral Reach Test</intervention_name>
      <description>To conduct the leg reach test, participants began by positioning themselves with their arms hanging at their sides. They were then guided to raise the leg under assessment and extend it across the opposite leg to make contact with a wooden bar, employing trunk rotation in the process. During each trial, participants were consistently motivated to ensure that both shoulders remained in contact with the floor and to stretch their tested leg as far as they could along the length of the wooden bar. If a participant was unable to sustain contact between their foot and the wooden bar for a duration of 5 seconds at the point of maximal reach, or if both shoulders lifted off the floor, that specific trial was considered invalid and not included in the analysis.&#xD;
  Each participant completed three repetitions of this test for both the right and left sides, and the average of their reach distances was subsequently calculated for assessment.</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adolescent tennis players&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Athletes with a history of musculoskeletal injury or surgery in the last year that&#xD;
               would prevent the tests from being performed&#xD;
  &#xD;
            -  Athletes who feel pain in the trunk and lower extremities during the tests&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>11 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zeynep Hazar</last_name>
      <role>Study Director</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Elif Aygün Polat</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sevim Beyza Ölmez</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gazi University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elif Aygün Polat</last_name>
      <phone>+90 312 2162601</phone>
      <email>fzteapolat@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gazi University</name>
        <address>
          <city>Ankara</city>
          <zip>06490</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Elif Aygün Polat</last_name>
        <phone>+90 312 2162601</phone>
        <email>fzteapolat@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Pontes-Silva A, Avila MA, de Araujo ADS, Penha TFC, Takahasi HY, Bassi-Dibai D, Dibai-Filho AV. Assessment of the Reliability of the Leg Lateral Reach Test to Measure Thoraco-Lumbo-Pelvic Rotation in Individuals With Chronic Low Back Pain. J Manipulative Physiol Ther. 2021 Sep;44(7):566-572. doi: 10.1016/j.jmpt.2021.12.001.</citation>
      <PMID>35282857</PMID>
    </results_reference>
    <results_reference>
      <citation>Kim SH, Kwon OY, Park KN, Hwang UJ. Leg lateral reach test: The reliability and correlation with thoraco-lumbo-pelvic rotation range. J Sci Med Sport. 2017 Jan;20(1):2-5. doi: 10.1016/j.jsams.2016.04.006. Epub 2016 May 2.</citation>
      <PMID>27210501</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gazi University</investigator_affiliation>
      <investigator_full_name>Sevim Beyza Ölmez</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Spine</keyword>
    <keyword>Leg lateral reach test</keyword>
    <keyword>Range of motion</keyword>
    <keyword>Tennis player</keyword>
    <keyword>Low Back Pain</keyword>
    <keyword>Mobility</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mobility Limitation</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Athletic Injuries</mesh_term>
      <mesh_term>Spinal Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not a plan to make IPD available.</ipd_description>
    </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/NCT06025656
  org study id: 2023-942
  nct id: NCT06025656
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the reliability and validity of the Leg Lateral Reach
        Test to measure thoraco-lumbo-pelvic segment mobility in adolescent tennis players. The fact
        that the test is valid and reliable for tennis players will contribute to monitoring trunk
        rotation flexibility in athletes, comparing them bilaterally, and revealing the exercise
        training necessary to improve performance.
  Tennis is a sport characterized by coordinated, repetitive, and rotational movements along
        the kinetic chain. Ineffective use of the trunk segment to generate rotational momentum is
        thought to increase the load on the upper extremity. Limited trunk rotation flexibility can
        cause abnormal trunk motion patterns, resulting in lower back injuries and pain as well as
        upper extremity injuries in throwing athletes. Therefore, assessment of trunk flexibility in
        athletes who perform repetitive trunk rotations, such as tennis players, is critical for
        effective rehabilitation and prevention of sports injuries.
  
        The Leg Lateral Reach Test was developed to measure the rotation of the thoraco-lumbo-pelvic
        segment and was found to be valid and reliable in physically active, healthy individuals.
        Therefore, the aim of this study is to evaluate the reliability and validity of the Leg
        Lateral Reach Test to measure thoraco-lumbo-pelvic segment mobility in adolescent tennis
        players. The fact that the test is valid and reliable for tennis players will contribute to
        monitoring trunk rotation flexibility in athletes, comparing them bilaterally, and revealing
        the exercise training necessary to improve performance.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Leg Lateral Reach Test-1
  time frame: first day
  description: The leg lateral reach test will be measured by the first investigator.
  measure: Leg Lateral Reach Test-2
  time frame: first day
  description: The leg lateral reach test will be measured by the second investigator.
  measure: Leg Lateral Reach Test-3
  time frame: 5-7 days after
  description: The leg lateral reach test will be measured by the first investigator.
  measure: Leg Lateral Reach Test-4
  time frame: 5-7 days after
  description: The leg lateral reach test will be measured by the second investigator.
  measure: Seated Rotation Test
  time frame: first day
  description: A seated rotation test will be measured for validity analysis.
  arm group label: Experimental group
  arm group type: Other
  description: adolescent tennis player
  intervention type: Diagnostic Test
  intervention name: Leg Lateral Reach Test
  description: To conduct the leg reach test, participants began by positioning themselves with their arms hanging at their sides. They were then guided to raise the leg under assessment and extend it across the opposite leg to make contact with a wooden bar, employing trunk rotation in the process. During each trial, participants were consistently motivated to ensure that both shoulders remained in contact with the floor and to stretch their tested leg as far as they could along the length of the wooden bar. If a participant was unable to sustain contact between their foot and the wooden bar for a duration of 5 seconds at the point of maximal reach, or if both shoulders lifted off the floor, that specific trial was considered invalid and not included in the analysis.
  Each participant completed three repetitions of this test for both the right and left sides, and the average of their reach distances was subsequently calculated for assessment.
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 11 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zeynep Hazar
  role: Study Director
  affiliation: Gazi University
  last name: Elif Aygün Polat
  role: Principal Investigator
  affiliation: Gazi University
  last name: Sevim Beyza Ölmez
  role: Principal Investigator
  affiliation: Gazi University
  last name: Elif Aygün Polat
  phone: +90 312 2162601
  email: fzteapolat@gmail.com
  facility: 
  contact: 
  country: Turkey
  citation: Pontes-Silva A, Avila MA, de Araujo ADS, Penha TFC, Takahasi HY, Bassi-Dibai D, Dibai-Filho AV. Assessment of the Reliability of the Leg Lateral Reach Test to Measure Thoraco-Lumbo-Pelvic Rotation in Individuals With Chronic Low Back Pain. J Manipulative Physiol Ther. 2021 Sep;44(7):566-572. doi: 10.1016/j.jmpt.2021.12.001.
  PMID: 35282857
  citation: Kim SH, Kwon OY, Park KN, Hwang UJ. Leg lateral reach test: The reliability and correlation with thoraco-lumbo-pelvic rotation range. J Sci Med Sport. 2017 Jan;20(1):2-5. doi: 10.1016/j.jsams.2016.04.006. Epub 2016 May 2.
  PMID: 27210501
  responsible party type: Principal Investigator
  investigator affiliation: Gazi University
  investigator full name: Sevim Beyza Ölmez
  investigator title: Principal Investigator
  mesh term: Mobility Limitation
  mesh term: Wounds and Injuries
  mesh term: Athletic Injuries
  mesh term: Spinal Injuries
  sharing ipd: No
  ipd description: There is not a plan to make IPD available.