<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/NCT03805464</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100862</org_study_id>
    <nct_id>NCT03805464</nct_id>
  </id_info>
  <brief_title>Walking Gait Biomechanics Following Knee Joint Effusion</brief_title>
  <official_title>Characterizing Changes in Knee Joint Loading With Wearable Sensor Technology Following an Experimental Knee Joint Effusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the sensitivity of a wearable sensor to detect&#xD;
      changes in knee joint loading using an experimental knee joint effusion as a model for a&#xD;
      common clinical physiological alteration in joint status. The rationale for this project is&#xD;
      that it will establish the efficacy of an inexpensive, clinically, and publicly available&#xD;
      device that can detect changes in biomechanical loading due to acute physiologic change in&#xD;
      joint status. The study will utilize a cross-sectional cohort study design and will seek to&#xD;
      enroll 25 male and female healthy adult participants (18-35 yo). Participants will report to&#xD;
      the laboratory for three total sessions (Session 1: informed consent and task&#xD;
      familiarization; Session 2: testing; Session 3: knee joint status assessment). The primary&#xD;
      outcomes of interest include lower extremity thigh and shank acceleration and velocity data&#xD;
      (wearable sensor data), lower extermity 3D kinematics and kinetics (motion capture data), and&#xD;
      lower extremity muscle function (EMG data) during walking gait, as well as functional balance&#xD;
      and patient-reported subjective outcomes. Data will be analyzed by calculating change scores&#xD;
      from the pre- to post-experimental effusion outcome measure testing. Paired-samples t-tests&#xD;
      and Cohen's d effect sizes will be used to assess changed in wearable sensor data from pre-&#xD;
      to post-experimental effusion. Correlation statistics will be used to determine if there are&#xD;
      association between the motion capture and wearable sensor data. The potential risks&#xD;
      associated with an experimental joint effusion will be addressed by maintaining appropriate&#xD;
      sterile conditions and having the participant check-in with the PI (licensed healthcare&#xD;
      provider) at 48 hours following testing session.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Peak Vertical Ground Reaction Force</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Kinetic Loading Variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Peak Internal Knee Extension Moment</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Kinetic Loading Variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Peak Knee Power</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Kinetic Loading Variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Shank Acceleration</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Accelerometer Variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Thigh Acceleration</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Accelerometer Variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Shank Angular Velocity</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Gyroscope Variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Thigh Angular Velocity</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Gyroscope Variable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quadriceps EMG</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Muscle Activity Variable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hamstring EMG</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Muscle Activity Variable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Analog Scale Pain</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Pain Variable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in International Knee Documentation Committee</measure>
    <time_frame>Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion</time_frame>
    <description>Self-Reported Disability Variable</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Knee Injuries</condition>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Knee Joint Effusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a one-time injection of 60mL of sterile saline into the suprapatellar space of the dominant lower extremity. This injection will be conducted under ultrasound guidance by a board-certified orthopedic surgeon.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Knee Joint Effusion</intervention_name>
    <description>60mL saline injection into the supra-patellar region of the knee</description>
    <arm_group_label>Knee Joint Effusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female&#xD;
&#xD;
          -  Chronological age 18-35 at the time of study participation&#xD;
&#xD;
          -  Physically active (at least 30 minutes of physical activity, 3x/week)&#xD;
&#xD;
          -  Tegner Activity Scale score at least 5/10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of lower extremity or lumbar spine surgery.&#xD;
&#xD;
          -  History of lower extremity or lumbar spine injury in the prior 6 months.&#xD;
&#xD;
          -  History of major ligamentous damage.&#xD;
&#xD;
          -  Current knee pain.&#xD;
&#xD;
          -  Known neurological condition, autoimmune condition, cardiovascular disease.&#xD;
&#xD;
          -  History of epilepsy, seizures, concussion within the prior 6 months.&#xD;
&#xD;
          -  Currently taking pain altering medication.&#xD;
&#xD;
          -  Fear of needles&#xD;
&#xD;
          -  Unable to read and understand English language&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Laura S Pietrosimone, PT, DPT, PhD</last_name>
    <phone>919.684.8930</phone>
    <email>laura.pietrosimone@duke.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Michael W. Krzyzewski Human Performance Laboratory</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura S Pietrosimone, PT, DPT, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 20, 2023</last_update_submitted>
  <last_update_submitted_qc>January 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biomechanics</keyword>
  <keyword>inertial measurement unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrarthrosis</mesh_term>
    <mesh_term>Knee Injuries</mesh_term>
  </condition_browse>
  <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/NCT03805464
org study id: Pro00100862
nct id: NCT03805464
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to determine the sensitivity of a wearable sensor to detect
      changes in knee joint loading using an experimental knee joint effusion as a model for a
      common clinical physiological alteration in joint status. The rationale for this project is
      that it will establish the efficacy of an inexpensive, clinically, and publicly available
      device that can detect changes in biomechanical loading due to acute physiologic change in
      joint status. The study will utilize a cross-sectional cohort study design and will seek to
      enroll 25 male and female healthy adult participants (18-35 yo). Participants will report to
      the laboratory for three total sessions (Session 1: informed consent and task
      familiarization; Session 2: testing; Session 3: knee joint status assessment). The primary
      outcomes of interest include lower extremity thigh and shank acceleration and velocity data
      (wearable sensor data), lower extermity 3D kinematics and kinetics (motion capture data), and
      lower extremity muscle function (EMG data) during walking gait, as well as functional balance
      and patient-reported subjective outcomes. Data will be analyzed by calculating change scores
      from the pre- to post-experimental effusion outcome measure testing. Paired-samples t-tests
      and Cohen's d effect sizes will be used to assess changed in wearable sensor data from pre-
      to post-experimental effusion. Correlation statistics will be used to determine if there are
      association between the motion capture and wearable sensor data. The potential risks
      associated with an experimental joint effusion will be addressed by maintaining appropriate
      sterile conditions and having the participant check-in with the PI (licensed healthcare
      provider) at 48 hours following testing session.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Peak Vertical Ground Reaction Force
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Kinetic Loading Variable
measure: Change in Peak Internal Knee Extension Moment
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Kinetic Loading Variable
measure: Change in Peak Knee Power
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Kinetic Loading Variable
measure: Change in Shank Acceleration
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Accelerometer Variable
measure: Change in Thigh Acceleration
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Accelerometer Variable
measure: Change in Shank Angular Velocity
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Gyroscope Variable
measure: Change in Thigh Angular Velocity
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Gyroscope Variable
measure: Change in Quadriceps EMG
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Muscle Activity Variable
measure: Change in Hamstring EMG
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Muscle Activity Variable
measure: Change in Visual Analog Scale Pain
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Pain Variable
measure: Change in International Knee Documentation Committee
time frame: Immediately Pre- (10 minutes) and Post- (10 minutes) Effusion
description: Self-Reported Disability Variable
arm group label: Knee Joint Effusion
arm group type: Experimental
description: Participants will receive a one-time injection of 60mL of sterile saline into the suprapatellar space of the dominant lower extremity. This injection will be conducted under ultrasound guidance by a board-certified orthopedic surgeon.
intervention type: Other
intervention name: Knee Joint Effusion
description: 60mL saline injection into the supra-patellar region of the knee
arm group label: Knee Joint Effusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Laura S Pietrosimone, PT, DPT, PhD
phone: 919.684.8930
email: laura.pietrosimone@duke.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Hydrarthrosis
mesh term: Knee Injuries
sharing ipd: No