<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/NCT04464902</url>
  </required_header>
  <id_info>
    <org_study_id>IR001</org_study_id>
    <nct_id>NCT04464902</nct_id>
  </id_info>
  <brief_title>The Effects of Knee Extension Constraint Rehabilitation After ACL Reconstruction</brief_title>
  <official_title>The Effects of Knee Extension Constraint Rehabilitation After ACL 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>
      To develop new prevention programs for non-contact ACL injuries that do not require&#xD;
      additional training time and assistance from a sports medicine professional personnel. A knee&#xD;
      extension constraint will be utilized to patients who have undertaken ACL reconstruction.&#xD;
&#xD;
      And to determine the effects of knee extension constraint rehabilitation on lower extremity&#xD;
      biomechanics after ACL reconstruction surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose Of exploring the biomechanical effect of knee extension constraint rehabilitation on&#xD;
      rehabilitation after anterior cruciate ligament (ACL) reconstruction. Methods: Recruit 60&#xD;
      patients after ACL reconstruction. Divide them into three groups by random block method: Knee&#xD;
      extension constraint rehabilitation group (wearing a brace with limitation of knee&#xD;
      extension), Placebo group (wearing a brace without limitation of knee extension), and Control&#xD;
      group (no brace is worn). The three groups of patients received the same rehabilitation&#xD;
      training from 1 to 12 weeks after surgery, starting from week 13 and intervening on the first&#xD;
      day of each week (wearing braces). Five tests were performed at the end of the 12th, 24th,&#xD;
      36th, and 48th weeks after surgery. Vicon system and force platform system will be&#xD;
      synchronized used to test walking, jogging, side-cutting, and jumping; The Isokinetic&#xD;
      dynamometer system will be used to test muscle strength. Outcome evaluation indicators and&#xD;
      statistical methods: (1) Mixed design two-way analysis of variances will be used for the&#xD;
      following indicators: approach run velocity and jump height; knee flexion angle at initial&#xD;
      foot contact with the ground; knee extension moment at the time of peak impact poster ground&#xD;
      reaction force, study group will be considered as an independent variable while testing time&#xD;
      as the variable for repeated measurements. (2) The knee flexion, valgus-varus, and&#xD;
      internal-external rotation angles, and extension, valgus-varus, and internal-external&#xD;
      rotation moments of each leg during support phase of each movement will be expressed as&#xD;
      functions of normalized movement time and leg (involved or uninvolved) using regression&#xD;
      analysis with dummy variable. A dummy variable will be used to represent involved and&#xD;
      uninvolved legs. A forward elimination procedure will be used to determine the best&#xD;
      regression equations. The regression procedure will be stopped when the contributions of&#xD;
      powers of n+1 and n+2 have no significant contribution to the overall regression. The&#xD;
      contribution of the dummy variable in the regression will be an indication of asymmetry of&#xD;
      the movements of involved and uninvolved legs. The effect of study group on movement&#xD;
      asymmetry will be determined by comparing the contribution of dummy variables to the overall&#xD;
      regression among study groups using a one-way ANOVA. The effects of study group and testing&#xD;
      time on the ACL injury risk index will be determined for each knee in each movement using&#xD;
      two-way ANOVA with mixed model. Study group will be considered as an independent variable&#xD;
      while testing time as a repeated measure variable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 28, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Patients and investigator all don't know which group they participated in.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>walking speed</measure>
    <time_frame>at 24 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>walking speed</measure>
    <time_frame>at 36 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>walking speed</measure>
    <time_frame>at 48 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ground reaction force</measure>
    <time_frame>at 24 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ground reaction force</measure>
    <time_frame>at 36 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ground reaction force</measure>
    <time_frame>at 48 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knee flexion angle</measure>
    <time_frame>at 24 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knee flexion angle</measure>
    <time_frame>at 36 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>knee flexion angle</measure>
    <time_frame>at 48 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system 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 24 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system 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 36 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system 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 48 weeks after ACL reconstruction surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The International Knee Documentation Committee (IKDC) score</measure>
    <time_frame>at 24 weeks after ACL reconstruction surgery.</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>
  <secondary_outcome>
    <measure>The International Knee Documentation Committee (IKDC) score</measure>
    <time_frame>at 36 weeks after ACL reconstruction surgery.</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>
  <secondary_outcome>
    <measure>The International Knee Documentation Committee (IKDC) score</measure>
    <time_frame>at 48 weeks after ACL reconstruction surgery.</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_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Anterior Cruciate Ligament Injuries</condition>
  <arm_group>
    <arm_group_label>knee extension constraint rehabilitation group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>brace1</intervention_name>
    <description>The brace1 can provide resistance when patients want to extend their knee.</description>
    <arm_group_label>knee extension constraint rehabilitation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>brace2</intervention_name>
    <description>The brace1 can't provide resistance when patients want to extend their knee.</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Intervention</intervention_name>
    <description>Control Group don't have any brace.</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have isolated ACL injury and receive ACL reconstruction surgery at Sports&#xD;
             Medicine Center, 3rd Hospital of Beijing University, Beijing, China.&#xD;
&#xD;
          -  18-35 years old&#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>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hongshi Huang, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yuanyuan Yu, Bachler</last_name>
    <phone>+8615201134356</phone>
    <email>YYY1091012@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongshi Huang, Doctor</last_name>
      <phone>01082267565</phone>
      <email>huanghs@bjmu.edu.cn</email>
    </contact>
  </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 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>injury prevention</keyword>
  <keyword>knee extension constraint</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04464902
org study id: IR001
nct id: NCT04464902
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To develop new prevention programs for non-contact ACL injuries that do not require
      additional training time and assistance from a sports medicine professional personnel. A knee
      extension constraint will be utilized to patients who have undertaken ACL reconstruction.

      And to determine the effects of knee extension constraint rehabilitation on lower extremity
      biomechanics after ACL reconstruction surgery.
Purpose Of exploring the biomechanical effect of knee extension constraint rehabilitation on
      rehabilitation after anterior cruciate ligament (ACL) reconstruction. Methods: Recruit 60
      patients after ACL reconstruction. Divide them into three groups by random block method: Knee
      extension constraint rehabilitation group (wearing a brace with limitation of knee
      extension), Placebo group (wearing a brace without limitation of knee extension), and Control
      group (no brace is worn). The three groups of patients received the same rehabilitation
      training from 1 to 12 weeks after surgery, starting from week 13 and intervening on the first
      day of each week (wearing braces). Five tests were performed at the end of the 12th, 24th,
      36th, and 48th weeks after surgery. Vicon system and force platform system will be
      synchronized used to test walking, jogging, side-cutting, and jumping; The Isokinetic
      dynamometer system will be used to test muscle strength. Outcome evaluation indicators and
      statistical methods: (1) Mixed design two-way analysis of variances will be used for the
      following indicators: approach run velocity and jump height; knee flexion angle at initial
      foot contact with the ground; knee extension moment at the time of peak impact poster ground
      reaction force, study group will be considered as an independent variable while testing time
      as the variable for repeated measurements. (2) The knee flexion, valgus-varus, and
      internal-external rotation angles, and extension, valgus-varus, and internal-external
      rotation moments of each leg during support phase of each movement will be expressed as
      functions of normalized movement time and leg (involved or uninvolved) using regression
      analysis with dummy variable. A dummy variable will be used to represent involved and
      uninvolved legs. A forward elimination procedure will be used to determine the best
      regression equations. The regression procedure will be stopped when the contributions of
      powers of n+1 and n+2 have no significant contribution to the overall regression. The
      contribution of the dummy variable in the regression will be an indication of asymmetry of
      the movements of involved and uninvolved legs. The effect of study group on movement
      asymmetry will be determined by comparing the contribution of dummy variables to the overall
      regression among study groups using a one-way ANOVA. The effects of study group and testing
      time on the ACL injury risk index will be determined for each knee in each movement using
      two-way ANOVA with mixed model. Study group will be considered as an independent variable
      while testing time as a repeated measure variable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Patients and investigator all don't know which group they participated in.
measure: walking speed
time frame: at 24 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: walking speed
time frame: at 36 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: walking speed
time frame: at 48 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: ground reaction force
time frame: at 24 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: ground reaction force
time frame: at 36 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: ground reaction force
time frame: at 48 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: knee flexion angle
time frame: at 24 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: knee flexion angle
time frame: at 36 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: knee flexion angle
time frame: at 48 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: the moment of knee extension in the gait cycle
time frame: at 24 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: the moment of knee extension in the gait cycle
time frame: at 36 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: the moment of knee extension in the gait cycle
time frame: at 48 weeks after ACL reconstruction surgery.
description: Three-dimensional gait analysis system were used during walking, jogging, cutting and jumping.
measure: The International Knee Documentation Committee (IKDC) score
time frame: at 24 weeks after ACL reconstruction surgery.
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.
measure: The International Knee Documentation Committee (IKDC) score
time frame: at 36 weeks after ACL reconstruction surgery.
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.
measure: The International Knee Documentation Committee (IKDC) score
time frame: at 48 weeks after ACL reconstruction surgery.
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: knee extension constraint rehabilitation group
arm group type: Other
arm group label: placebo group
arm group type: Other
arm group label: control group
arm group type: Other
intervention type: Device
intervention name: brace1
description: The brace1 can provide resistance when patients want to extend their knee.
arm group label: knee extension constraint rehabilitation group
intervention type: Device
intervention name: brace2
description: The brace1 can't provide resistance when patients want to extend their knee.
arm group label: placebo group
intervention type: Other
intervention name: No Intervention
description: Control Group don't have any brace.
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Hongshi Huang, Doctor
role: Study Chair
affiliation: Peking University Third Hospital
last name: Yuanyuan Yu, Bachler
phone: +8615201134356
email: YYY1091012@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Anterior Cruciate Ligament Injuries
sharing ipd: No