<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/NCT03285009</url>
  </required_header>
  <id_info>
    <org_study_id>S60760</org_study_id>
    <nct_id>NCT03285009</nct_id>
  </id_info>
  <brief_title>Movement Patterns in Young Volleyball Athletes</brief_title>
  <official_title>Optimizing Body and Movement Specific Characteristics in Volleyball Players to Reduces Injuries in Young Athletes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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>
      This project is a consequence of the research chair project studying the same phenomenon in&#xD;
      adult volleyball players. The project will make use of and be part of the routine medical&#xD;
      screening that is taken by the young players of the first degree of the Leuven Volleyball&#xD;
      School, Belgium. All young players must undergo a routine medical investigation and movement&#xD;
      screening. This is obliged by the law. The current project will use these data. Outcome&#xD;
      parameters will be used to advice the trainer staff of the school to adjust their training&#xD;
      interventions. This is normal routine too as the involved medical department has been&#xD;
      advising the school for many years. Players will be followed up for 6 weeks. After those 6&#xD;
      weeks, the movement screening will be repeated to evaluate the change in the different&#xD;
      outcome parameters. This last screening is not part of a normal routine as players normally&#xD;
      are investigated more in a subjective way. The medical team and school want to change that&#xD;
      routine.&#xD;
&#xD;
      Data will be used to further improve training modalities and sports performance and reduce&#xD;
      injury risk in these young athletes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Actual">December 23, 2018</completion_date>
  <primary_completion_date type="Actual">December 23, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Masking not possible as individual treatment is given</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of joint mobility</measure>
    <time_frame>Difference between baseline and 6 weeks</time_frame>
    <description>Mobility will be assessed by using goniometer measurements (degrees of movement)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of strength</measure>
    <time_frame>Difference between baseline and 6 weeks</time_frame>
    <description>Strength will be assessed by using handheld dynamo-meter data (Newton)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in balance score</measure>
    <time_frame>Difference between baseline and 6 weeks</time_frame>
    <description>Stability is measured using the score on the Star Excursion Balance Test (numeric score on balance scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lower limb joint angles during a single leg drop vertical jump</measure>
    <time_frame>Difference between baseline and 6 weeks</time_frame>
    <description>Movement quality is measured using joint angles (trunk, pelvis, hip, knee, ankle)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lumbopelvic stability score</measure>
    <time_frame>Difference between baseline and 6 weeks</time_frame>
    <description>Lumbopelvic stability is scored using 9 clinical tests (Bend knee fall out, Active straight leg raise, prone knee bend, sitting knee extension, standing bow, pelvic tilt, one leg stance, backward rocking, forward rocking). Each test is given a score between 0 (poor performance) and 2 (good performance) adding up to a total score of 18.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in lower limb joint angles during a drop jump</measure>
    <time_frame>Difference between baseline and 6 weeks</time_frame>
    <description>Movement quality is measured using joint angles (trunk, pelvis, hip, knee, ankle)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Individualized web diagram of all outcome measurements</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline data on joint mobility (joint angles), strength (N), balance (Star Excursion Balance Test Score, lumbopelvic control scores) and joint angles during a drop jump and single leg drop vertical jump) are all visualized on a web diagram per athlete</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of injuries</measure>
    <time_frame>Baseline information from medical investigation</time_frame>
    <description>Description of number of injuries</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Injuries</condition>
  <condition>Training</condition>
  <condition>Athlete</condition>
  <condition>Youth</condition>
  <arm_group>
    <arm_group_label>Training intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>See information elsewhere</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training intervention</intervention_name>
    <description>Based on the baseline screening, which is part of the normal prevention routine within the school, all athletes are given individual advice with regard to points of attention within training. For example: those athletes with reduced balance, will get more balance training.&#xD;
Intervention is individual as said and will be guided and supervised by the physical trainer and medical staff of the school.</description>
    <arm_group_label>Training intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All students from the first degree of the Volleyball school will participate&#xD;
&#xD;
          -  Male and female athletes will be included&#xD;
&#xD;
          -  Signing of an informed consent and assent form (for young kids) to use data for&#xD;
             research&#xD;
&#xD;
          -  Agreement given by the medical staff to use data and allowing the kids to be accepted&#xD;
             by the school&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  When inclusion criteria are not met&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Filip F Staes, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Prof. Dr. F. Staes</investigator_full_name>
    <investigator_title>Professor, Head of Musculoskeletal Research Group</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual data will be shared with other researchers. Data will be available to the medical and trainers staff. For research purposes, all data will be made anonymous.</ipd_description>
  </patient_data>
  <!-- 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/NCT03285009
org study id: S60760
nct id: NCT03285009
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project is a consequence of the research chair project studying the same phenomenon in
      adult volleyball players. The project will make use of and be part of the routine medical
      screening that is taken by the young players of the first degree of the Leuven Volleyball
      School, Belgium. All young players must undergo a routine medical investigation and movement
      screening. This is obliged by the law. The current project will use these data. Outcome
      parameters will be used to advice the trainer staff of the school to adjust their training
      interventions. This is normal routine too as the involved medical department has been
      advising the school for many years. Players will be followed up for 6 weeks. After those 6
      weeks, the movement screening will be repeated to evaluate the change in the different
      outcome parameters. This last screening is not part of a normal routine as players normally
      are investigated more in a subjective way. The medical team and school want to change that
      routine.

      Data will be used to further improve training modalities and sports performance and reduce
      injury risk in these young athletes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
masking description: Masking not possible as individual treatment is given
measure: Change of joint mobility
time frame: Difference between baseline and 6 weeks
description: Mobility will be assessed by using goniometer measurements (degrees of movement)
measure: Change of strength
time frame: Difference between baseline and 6 weeks
description: Strength will be assessed by using handheld dynamo-meter data (Newton)
measure: Change in balance score
time frame: Difference between baseline and 6 weeks
description: Stability is measured using the score on the Star Excursion Balance Test (numeric score on balance scale)
measure: Change in lower limb joint angles during a single leg drop vertical jump
time frame: Difference between baseline and 6 weeks
description: Movement quality is measured using joint angles (trunk, pelvis, hip, knee, ankle)
measure: Change in lumbopelvic stability score
time frame: Difference between baseline and 6 weeks
description: Lumbopelvic stability is scored using 9 clinical tests (Bend knee fall out, Active straight leg raise, prone knee bend, sitting knee extension, standing bow, pelvic tilt, one leg stance, backward rocking, forward rocking). Each test is given a score between 0 (poor performance) and 2 (good performance) adding up to a total score of 18.
measure: Change in lower limb joint angles during a drop jump
time frame: Difference between baseline and 6 weeks
description: Movement quality is measured using joint angles (trunk, pelvis, hip, knee, ankle)
measure: Individualized web diagram of all outcome measurements
time frame: Baseline
description: Baseline data on joint mobility (joint angles), strength (N), balance (Star Excursion Balance Test Score, lumbopelvic control scores) and joint angles during a drop jump and single leg drop vertical jump) are all visualized on a web diagram per athlete
measure: Number of injuries
time frame: Baseline information from medical investigation
description: Description of number of injuries
arm group label: Training intervention
arm group type: Other
description: See information elsewhere
intervention type: Other
intervention name: Training intervention
description: Based on the baseline screening, which is part of the normal prevention routine within the school, all athletes are given individual advice with regard to points of attention within training. For example: those athletes with reduced balance, will get more balance training.
Intervention is individual as said and will be guided and supervised by the physical trainer and medical staff of the school.
arm group label: Training intervention
criteria: 
gender: All
minimum age: 11 Years
maximum age: 13 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Filip F Staes, prof
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Prof. Dr. F. Staes
investigator title: Professor, Head of Musculoskeletal Research Group
sharing ipd: No
ipd description: No individual data will be shared with other researchers. Data will be available to the medical and trainers staff. For research purposes, all data will be made anonymous.