<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/NCT01729312</url>
  </required_header>
  <id_info>
    <org_study_id>female acl prevention study</org_study_id>
    <nct_id>NCT01729312</nct_id>
  </id_info>
  <brief_title>Female Acl Prevention Study Where we Look at Landing Techniques Pre/Post Nine Week Strenghtening Program</brief_title>
  <official_title>Pilot Study to See if There is a Improvement in Landing Techniques After a 9 Week Strenghtening Program, Which May Decrease ACL Tears in Female Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</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>
      To make reading this consent form easier, the word &quot;participant&quot; refers to you or your child&#xD;
      (if a minor) throughout the consent form. This research is being done to study the effects of&#xD;
      an eighteen-session strengthening program and to see if there is a relationship between the&#xD;
      female athletes improving their landing techniques which has been proven to decrease anterior&#xD;
      cruciate ligament injuries.&#xD;
&#xD;
      Participants have been asked to take part in a research study because you are a female&#xD;
      athlete involved in a sport that has an increased anterior cruciate ligament injury rate. The&#xD;
      purpose of this research study is to find out if an eighteen-session strengthening program&#xD;
      will decrease your anterior cruciate ligament injury rate.&#xD;
&#xD;
      There will be approximately ninety-four (94) people in this research study at Henry Ford&#xD;
      Health System (HFHS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research program is to use Dartfish technology and Functional Movement&#xD;
      Screen to assess female athletes pre- and post injury prevention program.The study will&#xD;
      include ninety-four females: forty-seven who complete a nine week program focusing on&#xD;
      neuromuscular and proprioceptive exercises to improve landing techniques, and forty-seven who&#xD;
      go about their normal preseason training regimen. This program has no more risk than if each&#xD;
      athlete were to work out at their own gym. Each athlete will be given two questionnaires&#xD;
      before and after completing the program in order to determine their level of activity has&#xD;
      changed as well as uncover any underlying knee issues. Participants will also go through a&#xD;
      series of functional and movement tests to reveal any imbalances, and determine whether or&#xD;
      not they have improved by going through the prevention program.&#xD;
&#xD;
      All functional and movement tests will be video recorded. These recordings will only be used&#xD;
      for the purpose of conducting this research study and will only be viewed by the HFHS&#xD;
      investigators participating in the study. We will follow-up with each athlete one year later&#xD;
      to see if there are any lasting effects from the program and re-test each athlete at that&#xD;
      time to validate any results&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not enough participants to validate study.&#xD;
  </why_stopped>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">7</enrollment>
  <condition>Prevention of ACL Thru Strengthening Program</condition>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      No biospecimens are taken&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        female athletes in age of 13-16&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:females only age 13-16 -&#xD;
&#xD;
        Exclusion Criteria:all males females younger than 13 and older than 16&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mercy High School</name>
      <address>
        <city>Farmington</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>February 24, 2017</last_update_submitted>
  <last_update_submitted_qc>February 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Maria Blokdijk</investigator_full_name>
    <investigator_title>certified athletic trainer</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT01729312
org study id: female acl prevention study
nct id: NCT01729312
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To make reading this consent form easier, the word "participant" refers to you or your child
      (if a minor) throughout the consent form. This research is being done to study the effects of
      an eighteen-session strengthening program and to see if there is a relationship between the
      female athletes improving their landing techniques which has been proven to decrease anterior
      cruciate ligament injuries.

      Participants have been asked to take part in a research study because you are a female
      athlete involved in a sport that has an increased anterior cruciate ligament injury rate. The
      purpose of this research study is to find out if an eighteen-session strengthening program
      will decrease your anterior cruciate ligament injury rate.

      There will be approximately ninety-four (94) people in this research study at Henry Ford
      Health System (HFHS).
The purpose of this research program is to use Dartfish technology and Functional Movement
      Screen to assess female athletes pre- and post injury prevention program.The study will
      include ninety-four females: forty-seven who complete a nine week program focusing on
      neuromuscular and proprioceptive exercises to improve landing techniques, and forty-seven who
      go about their normal preseason training regimen. This program has no more risk than if each
      athlete were to work out at their own gym. Each athlete will be given two questionnaires
      before and after completing the program in order to determine their level of activity has
      changed as well as uncover any underlying knee issues. Participants will also go through a
      series of functional and movement tests to reveal any imbalances, and determine whether or
      not they have improved by going through the prevention program.

      All functional and movement tests will be video recorded. These recordings will only be used
      for the purpose of conducting this research study and will only be viewed by the HFHS
      investigators participating in the study. We will follow-up with each athlete one year later
      to see if there are any lasting effects from the program and re-test each athlete at that
      time to validate any results
observational model: Case-Control
time perspective: Prospective
No biospecimens are taken
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 13 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Maria Blokdijk
investigator title: certified athletic trainer
sharing ipd: No