<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/NCT03302975</url>
  </required_header>
  <id_info>
    <org_study_id>H16-00413</org_study_id>
    <nct_id>NCT03302975</nct_id>
  </id_info>
  <brief_title>Running Retraining to Minimize Braking Forces</brief_title>
  <official_title>The Effect of a Gait Modification Training Program on Impact Loading and Running-related Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fortius Sport &amp; Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</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 proposed research study aims to investigate whether a gait modification training program&#xD;
      to decrease peak braking forces during the stance phase of running will result in a reduction&#xD;
      in impact loading and the incidence of running-related injuries among recreational distance&#xD;
      runners.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 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>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Braking Force</measure>
    <time_frame>15 weeks</time_frame>
    <description>The peak horizontal force applied in the posterior direction during the stance phase of running</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Vertical Loading Rate</measure>
    <time_frame>15 weeks</time_frame>
    <description>The average vertical loading rate during stance phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Step Length</measure>
    <time_frame>15 weeks</time_frame>
    <description>The average step length</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Athletic Injuries</condition>
  <arm_group>
    <arm_group_label>Real time biofeedback</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Real-time visual biofeedback of braking forces during a treadmill run.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Real-time visual biofeedback during treadmill running</intervention_name>
    <description>Real-time biofeedback of braking forces during running</description>
    <arm_group_label>Real time biofeedback</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to commit to a 15-week half-marathon training program&#xD;
&#xD;
          -  Have been running for at least 3 months prior to study commencement&#xD;
&#xD;
          -  Have participated in 2 or less half-marathons previously&#xD;
&#xD;
          -  Ability to run on a treadmill unaided&#xD;
&#xD;
          -  Ability to travel to testing facility for running analysis pre- and post-training&#xD;
             program as well as for gait retraining sessions&#xD;
&#xD;
          -  Ability to understand written and spoken English&#xD;
&#xD;
          -  Meet the screening requirements (display less than -0.27BW mean peak braking force at&#xD;
             baseline/screening assessment)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any lower extremity pathology in the previous 3 months or currently have pain in their&#xD;
             lower back or lower extremities while running&#xD;
&#xD;
          -  Have undergone hip, knee, or ankle joint surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael A Hunt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fortius Sport &amp; Health</name>
      <address>
        <city>Burnaby</city>
        <state>British Columbia</state>
        <zip>V5B 0A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <results_first_submitted>December 18, 2019</results_first_submitted>
  <results_first_submitted_qc>January 7, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 18, 2020</results_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Michael Hunt</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Running</keyword>
  <keyword>Biomechanics</keyword>
  <keyword>Kinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Athletic Injuries</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>February 10, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03302975/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Real Time Biofeedback</title>
          <description>Real-time visual biofeedback of braking forces during a treadmill run.&#xD;
Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Real Time Biofeedback</title>
          <description>Real-time visual biofeedback of braking forces during a treadmill run.&#xD;
Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.2" spread="8.7"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peak Braking Force</title>
          <units>Body Weight</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.28" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Step Length</title>
          <units>m</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.91" spread="0.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Peak Braking Force</title>
        <description>The peak horizontal force applied in the posterior direction during the stance phase of running</description>
        <time_frame>15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Biofeedback</title>
            <description>Real-time visual biofeedback of braking forces during a treadmill run.&#xD;
Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Braking Force</title>
          <description>The peak horizontal force applied in the posterior direction during the stance phase of running</description>
          <units>Body Weight</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Vertical Loading Rate</title>
        <description>The average vertical loading rate during stance phase</description>
        <time_frame>15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Biofeedback</title>
            <description>Real-time visual biofeedback of braking forces during a treadmill run.&#xD;
Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running</description>
          </group>
        </group_list>
        <measure>
          <title>Average Vertical Loading Rate</title>
          <description>The average vertical loading rate during stance phase</description>
          <units>Body Weight/second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.05" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Step Length</title>
        <description>The average step length</description>
        <time_frame>15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Real Time Biofeedback</title>
            <description>Real-time visual biofeedback of braking forces during a treadmill run.&#xD;
Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running</description>
          </group>
        </group_list>
        <measure>
          <title>Step Length</title>
          <description>The average step length</description>
          <units>m</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over a 15-week period over the course of the running training program.</time_frame>
      <desc>Adverse events were assessed using open-ended questions in the weekly questionnaire. For the purpose of analysis, adverse events were defined as new pain or discomfort lasting longer than 2 weeks in duration or requiring treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Real Time Biofeedback</title>
          <description>Real-time visual biofeedback of braking forces during a treadmill run.&#xD;
Real-time visual biofeedback during treadmill running: Real-time biofeedback of braking forces during running</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="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </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="12"/>
              </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>Chris Napier</name_or_title>
      <organization>Univeristy of British Columbia</organization>
      <phone>604-721-1310</phone>
      <email>chris.napier@ubc.ca</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/NCT03302975
org study id: H16-00413
nct id: NCT03302975
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed research study aims to investigate whether a gait modification training program
      to decrease peak braking forces during the stance phase of running will result in a reduction
      in impact loading and the incidence of running-related injuries among recreational distance
      runners.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Peak Braking Force
time frame: 15 weeks
description: The peak horizontal force applied in the posterior direction during the stance phase of running
measure: Average Vertical Loading Rate
time frame: 15 weeks
description: The average vertical loading rate during stance phase
measure: Step Length
time frame: 15 weeks
description: The average step length
arm group label: Real time biofeedback
arm group type: Experimental
description: Real-time visual biofeedback of braking forces during a treadmill run.
intervention type: Device
intervention name: Real-time visual biofeedback during treadmill running
description: Real-time biofeedback of braking forces during running
arm group label: Real time biofeedback
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael A Hunt, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Michael Hunt
investigator title: Associate Professor
mesh term: Athletic Injuries
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 