<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/NCT03273673</url>
  </required_header>
  <id_info>
    <org_study_id>17-007</org_study_id>
    <secondary_id>R21AR069865-01A1</secondary_id>
    <nct_id>NCT03273673</nct_id>
  </id_info>
  <brief_title>Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach</brief_title>
  <official_title>Reduction of Risk Factors for ACL Re-injuries Using an Innovative Biofeedback Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Virginia Polytechnic Institute and State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Virginia Polytechnic Institute and State University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      ACL injuries are common among athletes and due to residual muscle weakness, limited knee&#xD;
      motion and asymmetrical movement patterns after surgery many of these athletes will sustain&#xD;
      secondary ACL injuries following return to sports. This project seeks to determine if a novel&#xD;
      biofeedback-based rehabilitation approach can decrease a known risk factor for secondary&#xD;
      injuries to the ACL. The project specifically focuses on correcting asymmetric movement&#xD;
      patterns, a known risk factor for secondary injury that is not directly addressed by existing&#xD;
      interventions through a 6 week therapy based biofeedback intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nearly 1 in 60 adolescent athletes will suffer ACL injuries. Approximately 90% of these&#xD;
      injured athletes will undergo an ACL reconstruction at an estimated annual cost of $3&#xD;
      billion. While reconstruction and subsequent rehabilitation allow these athletes to return to&#xD;
      sports, they have a 15 fold increased risk of secondary ACL injuries, a tear of the ACL graft&#xD;
      or the contralateral ACL. As a result, development of an intervention to reduce the incidence&#xD;
      of secondary ACL tears would meet a critical need. One area in which existing interventions&#xD;
      might be improved is through an increased emphasis on correcting asymmetric movement&#xD;
      patterns-a known risk factor for secondary injury. Thus, our long-term objective is to&#xD;
      decrease the number of secondary ACL tears by decreasing side-to-side movement and loading&#xD;
      asymmetry. The modification of post-operative rehabilitation to focus on movement and loading&#xD;
      symmetry with shift the rehabilitation paradigm. Specifically, we propose to evaluate a novel&#xD;
      biofeedback training program that focuses on altering loading and movement patterns to&#xD;
      improve symmetry and overall lower extremity mechanics in a group of 40 (20 control, 20&#xD;
      intervention) adolescent ACL reconstructed patients. There are two core hypotheses of this&#xD;
      study: 1) biofeedback training will decrease known risk factors for secondary ACL injuries&#xD;
      immediately following the biofeedback program and these changes will be retained 6 week after&#xD;
      the completion of the biofeedback program; and 2) we will be able to recruit and enroll 40&#xD;
      patients and retain 80% of the patients through the end of the follow-up assessment&#xD;
      demonstrating the feasibility of the biofeedback intervention. Implementation of a&#xD;
      biofeedback program prior to returning to dynamic athletic activities could improve physical&#xD;
      performance outcomes, decrease secondary injury risk factors and ultimately decrease the&#xD;
      long-term joint degeneration and development of osteoarthritis that has been associated with&#xD;
      ACL reconstruction. Ultimately this work will lead to additional investigations to&#xD;
      definitively determine the impact of this novel biofeedback program, which could shift the&#xD;
      post-operative rehabilitation paradigm following ACL reconstruction to improve long-term&#xD;
      joint health in these adolescent patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2018</start_date>
  <completion_date type="Actual">May 5, 2020</completion_date>
  <primary_completion_date type="Actual">May 5, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study involves one active intervention group and an attention control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
    <masking_description>To reduce the possibility of bias, the biofeedback intervention will be completed by a single individual (clinician - Athletic trainer) and the biomechanical assessments will be completed by a second individual who will be blinded to the subject's group assignment (research technician).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Peak Knee Extension Moment Symmetry</measure>
    <time_frame>Baseline (week 0) and Post-intervention (week 6)</time_frame>
    <description>The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Peak Knee Extension Moment Symmetry</measure>
    <time_frame>Post-intervention (week 6) and Retention (week 12)</time_frame>
    <description>The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Frontal Plane Knee Range of Motion</measure>
    <time_frame>Baseline (week 0) and Post-intervention (week 6)</time_frame>
    <description>The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Frontal Plane Knee Range of Motion</measure>
    <time_frame>Post-intervention (week 6) and Retention (week 12)</time_frame>
    <description>The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Vertical Ground Reaction Force Symmetry</measure>
    <time_frame>Baseline (week 0) and Post-intervention (week 6)</time_frame>
    <description>The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Peak Vertical Ground Reaction Force Symmetry</measure>
    <time_frame>Post-intervention (week 6) and Retention (week 12)</time_frame>
    <description>The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Anterior Cruciate Ligament Injury</condition>
  <arm_group>
    <arm_group_label>Biofeedback Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biofeedback Intervention</intervention_name>
    <description>Visual and Tactile Biofeedback</description>
    <arm_group_label>Biofeedback Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of signed and dated informed consent form&#xD;
&#xD;
          2. ACL Reconstruction: primary, unilateral ACL reconstruction with no pain in the&#xD;
             contralateral leg&#xD;
&#xD;
          3. Rehabilitation: need to have completed at least 4.5 months of post-operative physical&#xD;
             therapy and be within approximately 6 weeks of being ready to be released by his/her&#xD;
             treating orthopaedic surgeon to return to full sport participation&#xD;
&#xD;
          4. Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study&#xD;
&#xD;
          5. Male or female, aged 14-21&#xD;
&#xD;
          6. Willing to adhere to the ACL Biofeedback intervention regimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. For females: currently pregnant or planning to become pregnant&#xD;
&#xD;
          2. History of more than one ACL reconstruction&#xD;
&#xD;
          3. Post-operative complications that required additional surgical intervention&#xD;
&#xD;
          4. Hospitalization for any reason other than the ACL reconstruction in the last 3 months&#xD;
&#xD;
          5. Plans for additional surgical procedures in the next 12 months&#xD;
&#xD;
          6. Live greater than 60 miles from the research lab&#xD;
&#xD;
          7. Have limitations that would prevent them from attending the biofeedback training&#xD;
             sessions&#xD;
&#xD;
          8. Motor neuron diseases, Parkinson's disease, multiple sclerosis&#xD;
&#xD;
          9. Severely impaired hearing or speech (patients must be able to respond to phone calls)&#xD;
&#xD;
         10. No access to a telephone&#xD;
&#xD;
         11. Participating in another ACL intervention&#xD;
&#xD;
         12. Inability to understand or speak English (since this will be required for the&#xD;
             patient-based intervention)&#xD;
&#xD;
         13. Other self-reported medical problem that would prohibit participation in the study&#xD;
&#xD;
         14. Other health condition or personal issue judged by a study team member or primary care&#xD;
             physician to make the patient inappropriate for study participation&#xD;
&#xD;
         15. Knee extension moment limb symmetry index (LSI) greater than or equal to 90% at the&#xD;
             time of the initial study assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robin M Queen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Virginia Polytechnic Institute and State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia Tech - Kevin P. Granata Biomechanics Lab</name>
      <address>
        <city>Blacksburg</city>
        <state>Virginia</state>
        <zip>24060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <results_first_submitted>October 28, 2020</results_first_submitted>
  <results_first_submitted_qc>December 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 4, 2020</results_first_posted>
  <last_update_submitted>December 3, 2020</last_update_submitted>
  <last_update_submitted_qc>December 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Virginia Polytechnic Institute and State University</investigator_affiliation>
    <investigator_full_name>Robin Queen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Secondary ACL Injury Prevention</keyword>
  <keyword>Visual Biofeedback</keyword>
  <keyword>Tactile Biofeedback</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
    <mesh_term>Reinjuries</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03273673/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Biofeedback Intervention</title>
          <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.&#xD;
Biofeedback Intervention: Visual and Tactile Biofeedback</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Biofeedback Intervention</title>
          <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.&#xD;
Biofeedback Intervention: Visual and Tactile Biofeedback</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.2" spread="1.6"/>
                    <measurement group_id="B2" value="16.4" spread="2.2"/>
                    <measurement group_id="B3" value="16.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peak Knee Extension Moment Symmetry</title>
          <units>% Symmetry</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47.9" spread="28.4"/>
                    <measurement group_id="B2" value="41.4" spread="16.3"/>
                    <measurement group_id="B3" value="44.3" spread="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Peak Knee Extension Moment Symmetry</title>
        <description>The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task</description>
        <time_frame>Baseline (week 0) and Post-intervention (week 6)</time_frame>
        <population>Analysis completed with participants with &gt;80% adherence</population>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback Intervention</title>
            <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.&#xD;
Biofeedback Intervention: Visual and Tactile Biofeedback</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Knee Extension Moment Symmetry</title>
          <description>The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task</description>
          <population>Analysis completed with participants with &gt;80% adherence</population>
          <units>% Symmetry</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.1" spread="33.8"/>
                    <measurement group_id="O2" value="44.2" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.6" spread="24.2"/>
                    <measurement group_id="O2" value="40.6" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Peak Knee Extension Moment Symmetry</title>
        <description>The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task</description>
        <time_frame>Post-intervention (week 6) and Retention (week 12)</time_frame>
        <population>Analysis completed with participants with &gt;80% adherence</population>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback Intervention</title>
            <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.&#xD;
Biofeedback Intervention: Visual and Tactile Biofeedback</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Knee Extension Moment Symmetry</title>
          <description>The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task</description>
          <population>Analysis completed with participants with &gt;80% adherence</population>
          <units>% Symmetry</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.6" spread="24.2"/>
                    <measurement group_id="O2" value="40.6" spread="16.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.7" spread="22.5"/>
                    <measurement group_id="O2" value="33.3" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Frontal Plane Knee Range of Motion</title>
        <description>The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task</description>
        <time_frame>Baseline (week 0) and Post-intervention (week 6)</time_frame>
        <population>Analysis completed with participants with &gt;80% adherence</population>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback Intervention</title>
            <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.&#xD;
Biofeedback Intervention: Visual and Tactile Biofeedback</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Frontal Plane Knee Range of Motion</title>
          <description>The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task</description>
          <population>Analysis completed with participants with &gt;80% adherence</population>
          <units>Degree</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="2.7"/>
                    <measurement group_id="O2" value="10.1" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="4.5"/>
                    <measurement group_id="O2" value="9.1" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Frontal Plane Knee Range of Motion</title>
        <description>The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task</description>
        <time_frame>Post-intervention (week 6) and Retention (week 12)</time_frame>
        <population>Analysis completed with participants with &gt;80% adherence</population>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback Intervention</title>
            <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.&#xD;
Biofeedback Intervention: Visual and Tactile Biofeedback</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Frontal Plane Knee Range of Motion</title>
          <description>The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task</description>
          <population>Analysis completed with participants with &gt;80% adherence</population>
          <units>Degree</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="4.5"/>
                    <measurement group_id="O2" value="9.1" spread="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="4.2"/>
                    <measurement group_id="O2" value="10.1" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Peak Vertical Ground Reaction Force Symmetry</title>
        <description>The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task</description>
        <time_frame>Baseline (week 0) and Post-intervention (week 6)</time_frame>
        <population>Analysis completed with participants with &gt;80% adherence</population>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback Intervention</title>
            <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.&#xD;
Biofeedback Intervention: Visual and Tactile Biofeedback</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Vertical Ground Reaction Force Symmetry</title>
          <description>The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task</description>
          <population>Analysis completed with participants with &gt;80% adherence</population>
          <units>% Symmetry</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.1" spread="23"/>
                    <measurement group_id="O2" value="28" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="14"/>
                    <measurement group_id="O2" value="25.7" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Peak Vertical Ground Reaction Force Symmetry</title>
        <description>The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task</description>
        <time_frame>Post-intervention (week 6) and Retention (week 12)</time_frame>
        <population>Analysis completed with participants with &gt;80% adherence</population>
        <group_list>
          <group group_id="O1">
            <title>Biofeedback Intervention</title>
            <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.&#xD;
Biofeedback Intervention: Visual and Tactile Biofeedback</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Peak Vertical Ground Reaction Force Symmetry</title>
          <description>The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task</description>
          <population>Analysis completed with participants with &gt;80% adherence</population>
          <units>% Symmetry</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="14"/>
                    <measurement group_id="O2" value="25.7" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Retention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.5" spread="14.5"/>
                    <measurement group_id="O2" value="22.7" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Data was collected over the 12 weeks during which the participants were active on the study.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Biofeedback Intervention</title>
          <description>The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.&#xD;
Biofeedback Intervention: Visual and Tactile Biofeedback</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Robin Queen</name_or_title>
      <organization>Virginia Tech</organization>
      <phone>(540) 231-3134</phone>
      <email>rmqueen@vt.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03273673
org study id: 17-007
secondary id: R21AR069865-01A1
nct id: NCT03273673
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
ACL injuries are common among athletes and due to residual muscle weakness, limited knee
      motion and asymmetrical movement patterns after surgery many of these athletes will sustain
      secondary ACL injuries following return to sports. This project seeks to determine if a novel
      biofeedback-based rehabilitation approach can decrease a known risk factor for secondary
      injuries to the ACL. The project specifically focuses on correcting asymmetric movement
      patterns, a known risk factor for secondary injury that is not directly addressed by existing
      interventions through a 6 week therapy based biofeedback intervention.
Nearly 1 in 60 adolescent athletes will suffer ACL injuries. Approximately 90% of these
      injured athletes will undergo an ACL reconstruction at an estimated annual cost of $3
      billion. While reconstruction and subsequent rehabilitation allow these athletes to return to
      sports, they have a 15 fold increased risk of secondary ACL injuries, a tear of the ACL graft
      or the contralateral ACL. As a result, development of an intervention to reduce the incidence
      of secondary ACL tears would meet a critical need. One area in which existing interventions
      might be improved is through an increased emphasis on correcting asymmetric movement
      patterns-a known risk factor for secondary injury. Thus, our long-term objective is to
      decrease the number of secondary ACL tears by decreasing side-to-side movement and loading
      asymmetry. The modification of post-operative rehabilitation to focus on movement and loading
      symmetry with shift the rehabilitation paradigm. Specifically, we propose to evaluate a novel
      biofeedback training program that focuses on altering loading and movement patterns to
      improve symmetry and overall lower extremity mechanics in a group of 40 (20 control, 20
      intervention) adolescent ACL reconstructed patients. There are two core hypotheses of this
      study: 1) biofeedback training will decrease known risk factors for secondary ACL injuries
      immediately following the biofeedback program and these changes will be retained 6 week after
      the completion of the biofeedback program; and 2) we will be able to recruit and enroll 40
      patients and retain 80% of the patients through the end of the follow-up assessment
      demonstrating the feasibility of the biofeedback intervention. Implementation of a
      biofeedback program prior to returning to dynamic athletic activities could improve physical
      performance outcomes, decrease secondary injury risk factors and ultimately decrease the
      long-term joint degeneration and development of osteoarthritis that has been associated with
      ACL reconstruction. Ultimately this work will lead to additional investigations to
      definitively determine the impact of this novel biofeedback program, which could shift the
      post-operative rehabilitation paradigm following ACL reconstruction to improve long-term
      joint health in these adolescent patients.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study involves one active intervention group and an attention control group
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
masking description: To reduce the possibility of bias, the biofeedback intervention will be completed by a single individual (clinician - Athletic trainer) and the biomechanical assessments will be completed by a second individual who will be blinded to the subject's group assignment (research technician).
measure: Change in Peak Knee Extension Moment Symmetry
time frame: Baseline (week 0) and Post-intervention (week 6)
description: The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
measure: Change in Peak Knee Extension Moment Symmetry
time frame: Post-intervention (week 6) and Retention (week 12)
description: The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
measure: Change in Frontal Plane Knee Range of Motion
time frame: Baseline (week 0) and Post-intervention (week 6)
description: The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
measure: Change in Frontal Plane Knee Range of Motion
time frame: Post-intervention (week 6) and Retention (week 12)
description: The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
measure: Change in Peak Vertical Ground Reaction Force Symmetry
time frame: Baseline (week 0) and Post-intervention (week 6)
description: The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
measure: Change in Peak Vertical Ground Reaction Force Symmetry
time frame: Post-intervention (week 6) and Retention (week 12)
description: The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
arm group label: Biofeedback Intervention
arm group type: Experimental
description: The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue.
arm group label: Control
arm group type: No Intervention
description: The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6.
intervention type: Other
intervention name: Biofeedback Intervention
description: Visual and Tactile Biofeedback
arm group label: Biofeedback Intervention
criteria: 
gender: All
minimum age: 14 Years
maximum age: 21 Years
healthy volunteers: No
last name: Robin M Queen, PhD
role: Principal Investigator
affiliation: Virginia Polytechnic Institute and State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Virginia Polytechnic Institute and State University
investigator full name: Robin Queen
investigator title: Associate Professor
mesh term: Wounds and Injuries
mesh term: Anterior Cruciate Ligament Injuries
mesh term: Reinjuries
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 