<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/NCT04464330</url>
  </required_header>
  <id_info>
    <org_study_id>OR004</org_study_id>
    <nct_id>NCT04464330</nct_id>
  </id_info>
  <brief_title>Biomechanical Mechanism of the Change of the Gait Touch Information After ACL Rupture</brief_title>
  <official_title>Biomechanical Mechanism of the Change of the Gait Touch Information After ACL Rupture</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>
      The purpose of this study is to identify the characteristics of the disease, diagnose the&#xD;
      disease by computer and evaluate the rehabilitation based on gait touch information after ACL&#xD;
      rupture and reconstruction, combined with the methods of multi-body dynamics, machine&#xD;
      learning and biomechanics analysis. Methods: 55 healthy volunteers, 55 patients with ACL&#xD;
      rupture were recruited. Three dimensional gait analysis and dynamic plantar pressure were&#xD;
      used to test the kinematic and dynamic data of lower limbs and gait touch information when&#xD;
      walking, jogging, stopping and jumping, and running side cutting.&#xD;
&#xD;
      Outcome evaluation indexes and statistical methods:&#xD;
&#xD;
      the following indexes were measured repeatedly by two factor ANOVA method, and the left and&#xD;
      right sides and different rehabilitation time were used as the variables of repeated&#xD;
      measurement: the biomechanics of the lower limb joint and the change of the biological&#xD;
      characteristics of gait touch information were analyzed. To study the biomechanical status of&#xD;
      different knee joints and the mechanism of the change of gait touch information. Finally,&#xD;
      based on the information of gait touch, a biomechanical evaluation model of knee joint during&#xD;
      walking or jogging is established, which provides the exact basis for quantifying and&#xD;
      evaluating the biomechanical state of knee joint under the dynamic load-bearing state of gait&#xD;
      touch information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 2, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</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>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>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>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 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>
  <secondary_outcome>
    <measure>The International Knee Documentation Committee (IKDC) score</measure>
    <time_frame>On the day of enrollment.</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. The higher is better.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">110</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, patients who has 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;
          -  Cognitive impairment&#xD;
&#xD;
          -  Other injuries affecting movement performance.&#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 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 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 9, 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/NCT04464330
org study id: OR004
nct id: NCT04464330
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.
The purpose of this study is to identify the characteristics of the disease, diagnose the
      disease by computer and evaluate the rehabilitation based on gait touch information after ACL
      rupture and reconstruction, combined with the methods of multi-body dynamics, machine
      learning and biomechanics analysis. Methods: 55 healthy volunteers, 55 patients with ACL
      rupture were recruited. Three dimensional gait analysis and dynamic plantar pressure were
      used to test the kinematic and dynamic data of lower limbs and gait touch information when
      walking, jogging, stopping and jumping, and running side cutting.

      Outcome evaluation indexes and statistical methods:

      the following indexes were measured repeatedly by two factor ANOVA method, and 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 gait touch information were analyzed. To study the biomechanical status of
      different knee joints and the mechanism of the change of gait touch information. Finally,
      based on the information of gait touch, a biomechanical evaluation model of knee joint during
      walking or jogging is established, which provides the exact basis for quantifying and
      evaluating the biomechanical state of knee joint under the dynamic load-bearing state of gait
      touch information.
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: 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: 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: 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 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 International Knee Documentation Committee (IKDC) score
time frame: On the day of enrollment.
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. The higher is better.
arm group label: Anterior Cruciate Ligament injury and reconstruction group
description: According to the previous clinical diagnosis, patients who has 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