<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/NCT04462432</url>
  </required_header>
  <id_info>
    <org_study_id>OR003</org_study_id>
    <nct_id>NCT04462432</nct_id>
  </id_info>
  <brief_title>Spatiotemporal Characteristics and Multi-body Dynamics Modeling Information After ACL Rupture and Reconstruction</brief_title>
  <official_title>Spatiotemporal Characteristics and Multi-body Dynamics Modeling of Gait Touch Information After Anterior Cruciate Ligament Rupture and Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      High incidence rate of knee osteoarthritis and gait analysis are important for early&#xD;
      assessment of biomechanics. ACL injury is an ideal clinical model for studying knee&#xD;
      osteoarthritis.&#xD;
&#xD;
      To clarify the mechanism between the biomechanical status of knee joint and the change of&#xD;
      gait touch information, and to provide scientific basis for quantifying and evaluating the&#xD;
      biomechanical status of knee joint in dynamic load-bearing state.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To clarify the relationship between the normal and abnormal biomechanical status of&#xD;
      the knee joint and the gait touch information, and to establish the biomechanical evaluation&#xD;
      model of the knee joint during walking or jogging, taking into account the comprehensive&#xD;
      effects of sports parameters, individual attribute parameters and other factors. An automatic&#xD;
      analysis and expert diagnosis system was established to evaluate the biomechanics of knee&#xD;
      joint.&#xD;
&#xD;
      Methods: 50 young male (23-35 years old) healthy volunteers and 100 patients with unilateral&#xD;
      simple ACL rupture who need surgical treatment were recruited, 150 subjects in total. Three&#xD;
      tests were performed before surgery, at the end of the 24th and 48th weeks after surgery. All&#xD;
      were tested with three-dimensional gait analysis, dynamic plantar pressure measurement and&#xD;
      isokinetic muscle strength during walking, jogging, emergency stop and take-off, side cut.&#xD;
&#xD;
      Outcome evaluation indicators and statistical methods: Two-way ANOVA method of repeated&#xD;
      measurement was used, the left and right sides and different rehabilitation time were used as&#xD;
      the variables of repeated measurement: the biomechanics of the lower limb joint and the&#xD;
      change of the biological characteristics of the gait touch information were analyzed. Three&#xD;
      dimensional gait analysis and computer-aided analysis of gait touch information were used to&#xD;
      study the changes of ACL rupture and reconstruction. Based on the information of gait touch,&#xD;
      taking into account the comprehensive effects of sports parameters, individual attribute&#xD;
      parameters and other factors, a biomechanical evaluation model of knee joint during walking&#xD;
      or jogging is established, which provides the exact basis for quantifying the information of&#xD;
      gait touch and evaluating the biomechanical state of knee joint after ACL rupture and&#xD;
      reconstruction under dynamic load-bearing state, and establishes a clinical practical&#xD;
      automatic analysis and expert diagnosis system of gait touch information to evaluate the&#xD;
      biomechanics of the knee joint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 2, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 8, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>walking speed</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>walking speed</measure>
    <time_frame>at 24th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>walking speed</measure>
    <time_frame>at 48th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ground reaction force</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ground reaction force</measure>
    <time_frame>at 24th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ground reaction force</measure>
    <time_frame>at 48th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knee flexion angle</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knee flexion angle</measure>
    <time_frame>at 24th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knee flexion angle</measure>
    <time_frame>at 48th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee extension in the gait cycle</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee extension in the gait cycle</measure>
    <time_frame>at 24th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee extension in the gait cycle</measure>
    <time_frame>at 48th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee flexion in the gait cycle</measure>
    <time_frame>On the day of enrollment.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee flexion in the gait cycle</measure>
    <time_frame>at 24th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee flexion in the gait cycle</measure>
    <time_frame>at 48th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The International Knee Documentation Committee (IKDC) score</measure>
    <time_frame>On the day of enrollment, at 24th and 48th weeks after Anterior Cruciate Ligament reconstruction.</time_frame>
    <description>The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Anterior Cruciate Ligament Injuries</condition>
  <arm_group>
    <arm_group_label>Anterior Cruciate Ligament injury and reconstruction group</arm_group_label>
    <description>According to the previous clinical diagnosis, volunteers who has never suffered the Anterior Cruciate Ligament injury.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal control group</arm_group_label>
    <description>According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>This is an observation study, with no intervention.</description>
    <arm_group_label>Anterior Cruciate Ligament injury and reconstruction group</arm_group_label>
    <arm_group_label>normal control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion criteria: Age: 18-35 years old. Patients who have isolated ACL injury and receive&#xD;
        ACL reconstruction surgery at Peking University Third Hospital. With isolated ACL injury&#xD;
        (an ACL injury with no need for surgical repairs to other knee structures). All&#xD;
        participants have no known disorders or diseases other than ACL rupture.&#xD;
&#xD;
        Exclusion criteria: Female patients who are pregnant, or suspected pregnant, or in&#xD;
        breastfeeding will be excluded from this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-35 years old&#xD;
&#xD;
          -  Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking&#xD;
             University Third Hospital.&#xD;
&#xD;
          -  With isolated ACL injury (an ACL injury with no need for surgical repairs to other&#xD;
             knee structures).&#xD;
&#xD;
          -  All participants have no known disorders or diseases other than ACL rupture.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be&#xD;
             excluded from this study.&#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_official>
    <last_name>Hongshi Huang, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anterior cruciate ligament</keyword>
  <keyword>gait analysis</keyword>
  <keyword>plantar pressure</keyword>
  <keyword>multi-body dynamics modeling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
    <mesh_term>Anterior Cruciate Ligament 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/NCT04462432
org study id: OR003
nct id: NCT04462432
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
High incidence rate of knee osteoarthritis and gait analysis are important for early
      assessment of biomechanics. ACL injury is an ideal clinical model for studying knee
      osteoarthritis.

      To clarify the mechanism between the biomechanical status of knee joint and the change of
      gait touch information, and to provide scientific basis for quantifying and evaluating the
      biomechanical status of knee joint in dynamic load-bearing state.
Purpose: To clarify the relationship between the normal and abnormal biomechanical status of
      the knee joint and the gait touch information, and to establish the biomechanical evaluation
      model of the knee joint during walking or jogging, taking into account the comprehensive
      effects of sports parameters, individual attribute parameters and other factors. An automatic
      analysis and expert diagnosis system was established to evaluate the biomechanics of knee
      joint.

      Methods: 50 young male (23-35 years old) healthy volunteers and 100 patients with unilateral
      simple ACL rupture who need surgical treatment were recruited, 150 subjects in total. Three
      tests were performed before surgery, at the end of the 24th and 48th weeks after surgery. All
      were tested with three-dimensional gait analysis, dynamic plantar pressure measurement and
      isokinetic muscle strength during walking, jogging, emergency stop and take-off, side cut.

      Outcome evaluation indicators and statistical methods: Two-way ANOVA method of repeated
      measurement was used, the left and right sides and different rehabilitation time were used as
      the variables of repeated measurement: the biomechanics of the lower limb joint and the
      change of the biological characteristics of the gait touch information were analyzed. Three
      dimensional gait analysis and computer-aided analysis of gait touch information were used to
      study the changes of ACL rupture and reconstruction. Based on the information of gait touch,
      taking into account the comprehensive effects of sports parameters, individual attribute
      parameters and other factors, a biomechanical evaluation model of knee joint during walking
      or jogging is established, which provides the exact basis for quantifying the information of
      gait touch and evaluating the biomechanical state of knee joint after ACL rupture and
      reconstruction under dynamic load-bearing state, and establishes a clinical practical
      automatic analysis and expert diagnosis system of gait touch information to evaluate the
      biomechanics of the knee joint.
observational model: Case-Control
time perspective: Prospective
measure: walking speed
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: walking speed
time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: walking speed
time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: ground reaction force
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: ground reaction force
time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: ground reaction force
time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: knee flexion angle
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: knee flexion angle
time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: knee flexion angle
time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: the moment of knee extension in the gait cycle
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: the moment of knee extension in the gait cycle
time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: the moment of knee extension in the gait cycle
time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: the moment of knee flexion in the gait cycle
time frame: On the day of enrollment.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: the moment of knee flexion in the gait cycle
time frame: at 24th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: the moment of knee flexion in the gait cycle
time frame: at 48th weeks after Anterior Cruciate Ligament reconstruction.
description: Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.
measure: The International Knee Documentation Committee (IKDC) score
time frame: On the day of enrollment, at 24th and 48th weeks after Anterior Cruciate Ligament reconstruction.
description: The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.
arm group label: Anterior Cruciate Ligament injury and reconstruction group
description: According to the previous clinical diagnosis, volunteers who has never suffered the Anterior Cruciate Ligament injury.
arm group label: normal control group
description: According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.
intervention type: Other
intervention name: no intervention
description: This is an observation study, with no intervention.
arm group label: Anterior Cruciate Ligament injury and reconstruction group
arm group label: normal control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hongshi Huang, Doctor
role: Study Chair
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Rupture
mesh term: Anterior Cruciate Ligament Injuries
sharing ipd: No