<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/NCT03035994</url>
  </required_header>
  <id_info>
    <org_study_id>16-0409</org_study_id>
    <nct_id>NCT03035994</nct_id>
  </id_info>
  <brief_title>Effect of Altered Mechanical Loading in ACLR</brief_title>
  <official_title>Effect of Altered Mechanical Loading on Lower Extremity Biomechanics and Biochemical Markers in Individuals With an Anterior Cruciate Ligament Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</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>
      Altered loading is a causative factor for the development of knee osteoarthritis following&#xD;
      anterior cruciate ligament reconstruction (ACLR), and real-time biofeedback may be an&#xD;
      effective intervention to manipulate altered mechanical loading about the knee. The purpose&#xD;
      of this study is to 1) determine if ACLR participants are able to acquire and retain various&#xD;
      loading patterns using real-time biofeedback, 2) determine the effect of altered loading on&#xD;
      lower extremity biomechanics during walking gait, and 3) determine the effect of altered&#xD;
      loading on biochemical markers of collagen turnover and inflammation during walking gait.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will attend 4 testing sessions. Lower extremity biomechanical outcomes and blood&#xD;
      samples will be taken before and following the participant walking at a self-selected speed&#xD;
      for 20 minutes. During the 20 minutes of treadmill walking real-time biofeedback will be&#xD;
      displayed in an attempt to alter mechanical loading. Participants will complete a control,&#xD;
      overloading, under-loading, average loading testing session. Order of loading condition will&#xD;
      be randomized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in acquisition as measured in root mean square error (RMSE) between loading conditions</measure>
    <time_frame>Change in acquisition over 20 minute intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in joint loading as measured in peak vertical ground reaction force normalized to body weight (xBW) between loading conditions</measure>
    <time_frame>Change in joint loading over 20 minute intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in cartilage turnover as measured in serum concentration of cartilage oligomeric matrix protein (pg/mL) between loading conditions</measure>
    <time_frame>Chance in cartilage turnover over 20 minute intervention</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Anterior Cruciate Ligament Reconstruction</condition>
  <arm_group>
    <arm_group_label>Overloading</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force. A target will be placed at 10% greater than the participant's baseline vertical ground reaction force. Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Underloading</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force. A target will be placed at 10% lower than the participant's baseline vertical ground reaction force. Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Average</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force. A target will be placed at the average of each participant's baseline vertical ground reaction force between limbs. Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will walk for 20 minutes on a force-instrumented treadmill and will not be provided biofeedback.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Real-Time Biofeedback</intervention_name>
    <description>A custom written MatLab script will sample bilateral peak vertical ground reaction forces and display the magnitude in real time on a screen placed in front of the participant. A target line will be placed in the middle of the screen which corresponds to one of the three loading conditions. Participants will be instructed to alter their movement in an attempt to match each limb's vertical ground reaction force to the target line.</description>
    <arm_group_label>Average</arm_group_label>
    <arm_group_label>Overloading</arm_group_label>
    <arm_group_label>Underloading</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a history of a primary, unilateral ACLR using either a hamstring or patellar&#xD;
             tendon autograft, cleared by a physical for full return to physical activity with no&#xD;
             limitations, and participate in at least 30 minutes of physical activity 3 times per&#xD;
             week&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of injury to either leg, other than ACLR (e.g. ankle sprain, muscle strain),&#xD;
             within 6 months prior to participation in the study, history of lower extremity&#xD;
             surgery other than ACLR, history of osteoarthritis or current symptoms related to knee&#xD;
             osteoarthritis (e.g. pain, swelling, stiffness), currently pregnant, or planning to&#xD;
             become pregnant while enrolled in the study, cardiovascular restrictions that limit&#xD;
             the participant's ability to participate in physical activity.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian Pietrosimone, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>April 17, 2017</last_update_submitted>
  <last_update_submitted_qc>April 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03035994
org study id: 16-0409
nct id: NCT03035994
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Altered loading is a causative factor for the development of knee osteoarthritis following
      anterior cruciate ligament reconstruction (ACLR), and real-time biofeedback may be an
      effective intervention to manipulate altered mechanical loading about the knee. The purpose
      of this study is to 1) determine if ACLR participants are able to acquire and retain various
      loading patterns using real-time biofeedback, 2) determine the effect of altered loading on
      lower extremity biomechanics during walking gait, and 3) determine the effect of altered
      loading on biochemical markers of collagen turnover and inflammation during walking gait.
Participants will attend 4 testing sessions. Lower extremity biomechanical outcomes and blood
      samples will be taken before and following the participant walking at a self-selected speed
      for 20 minutes. During the 20 minutes of treadmill walking real-time biofeedback will be
      displayed in an attempt to alter mechanical loading. Participants will complete a control,
      overloading, under-loading, average loading testing session. Order of loading condition will
      be randomized.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Difference in acquisition as measured in root mean square error (RMSE) between loading conditions
time frame: Change in acquisition over 20 minute intervention
measure: Difference in joint loading as measured in peak vertical ground reaction force normalized to body weight (xBW) between loading conditions
time frame: Change in joint loading over 20 minute intervention
measure: Difference in cartilage turnover as measured in serum concentration of cartilage oligomeric matrix protein (pg/mL) between loading conditions
time frame: Chance in cartilage turnover over 20 minute intervention
arm group label: Overloading
arm group type: Experimental
description: Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force. A target will be placed at 10% greater than the participant's baseline vertical ground reaction force. Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.
arm group label: Underloading
arm group type: Experimental
description: Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force. A target will be placed at 10% lower than the participant's baseline vertical ground reaction force. Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.
arm group label: Average
arm group type: Experimental
description: Participants will walk on a force-instrumented treadmill for 20 minutes and will be provided visual biofeedback consisting of bilateral vertical ground reaction force. A target will be placed at the average of each participant's baseline vertical ground reaction force between limbs. Participants will be asked to alter their walking gait in an attempt to reach the target line with each step.
arm group label: Control
arm group type: No Intervention
description: Participants will walk for 20 minutes on a force-instrumented treadmill and will not be provided biofeedback.
intervention type: Other
intervention name: Real-Time Biofeedback
description: A custom written MatLab script will sample bilateral peak vertical ground reaction forces and display the magnitude in real time on a screen placed in front of the participant. A target line will be placed in the middle of the screen which corresponds to one of the three loading conditions. Participants will be instructed to alter their movement in an attempt to match each limb's vertical ground reaction force to the target line.
arm group label: Average
arm group label: Overloading
arm group label: Underloading
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Brian Pietrosimone, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
responsible party type: Sponsor
sharing ipd: No