<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/NCT04461145</url>
  </required_header>
  <id_info>
    <org_study_id>OR002</org_study_id>
    <nct_id>NCT04461145</nct_id>
  </id_info>
  <brief_title>Effect of Dual Tasks on Gait Symmetry After Anterior Cruciate Ligament Reconstruction</brief_title>
  <official_title>Effect of Dual Tasks on Gait Symmetry After Anterior Cruciate Ligament 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>
      Individuals who received anterior cruciate ligament (ACL) reconstruction demonstrated lower&#xD;
      extremity movement asymmetries. The purpose of this study was to determine if psychological&#xD;
      impairment was a contributor to lower extremity movement asymmetries in walking for&#xD;
      individuals who received ACL reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Anterior cruciate ligament (ACL) reconstruction is a commonly surgical procedure&#xD;
      to restore knee functions after an ACL injury. Lower extremity movement asymmetries were&#xD;
      found to be predictive of ACL re-injury and knee OA after ACL reconstruction. Although these&#xD;
      studies indicated that psychological impairments may contribute to patients' movement&#xD;
      asymmetries after ACL reconstruction surgery, the effect of psychological impairment on lower&#xD;
      extremity movement asymmetries has not been confirmed yet.&#xD;
&#xD;
      Methods: Each participant was asked to wear a pair of black spandex shorts. Passive&#xD;
      reflective markers were placed bilaterally at the anterior superior iliac spine, posterior&#xD;
      superior iliac spine, lateral thigh, lateral femoral condyle, medial femoral condyle,&#xD;
      anterior superior shank, anterior inferior shank, lateral malleoli, medial malleoli, heel,&#xD;
      and first and fifth metatarsophalangeal. The participant was instructed to walk with barefoot&#xD;
      in two conditions: (1) without cognitive task (single-task condition), and (2) with&#xD;
      concurrent cognitive task (dual-task condition). In single-task condition, the participant&#xD;
      walked along a 10-m walkway at self-selected walking speed. In dual-task condition, the&#xD;
      participant walked along the walkway while backward counting numbers with an increment of&#xD;
      seven starting from a randomly given number between 125 and 250. In dual-task condition,&#xD;
      participants immediately initiated the walking task at their preferred speed once they heard&#xD;
      the number read by the investigator and kept counting out loudly as required without&#xD;
      repeating the given number. Participants were asked to count as fast as possible while&#xD;
      walking task. A 5 min rest was requested between single-task and dual-task test. The order of&#xD;
      conditions was randomized for the participant. Quadriceps strength was evaluated for the&#xD;
      participant after walking test.&#xD;
&#xD;
      Three-dimensional (3-D) trajectories of the reflective markers were collected using an&#xD;
      8-camera motion capture system (VICON, Oxford, UK) at a sample rate of 100 Hz.&#xD;
      Ground-reaction force signals were collected using two embedded force plates (AMTI,&#xD;
      Watertown, Massachusetts) at a sample rate of 1000 Hz. Each participant was asked to have&#xD;
      three successful trials for each condition. A successful trial was defined as a trial in&#xD;
      which the participant performed the task as required, and all kinematic and kinetic data were&#xD;
      collected.&#xD;
&#xD;
      Quadriceps isometric strength was quantified with an isokinetic dynamometer (CON-TREX MJ;&#xD;
      Germany) during a maximum voluntary isometric contraction (MVIC). The participant was seated&#xD;
      with a hip flexed at 90° and knee flexed at 60°. The lateral femoral condyle was aligned with&#xD;
      the dynamometer axis, and the dynamometer resistance pad was secured to the anterior aspect&#xD;
      of the distal shank. After correcting for leg weight, the participant was asked to perform&#xD;
      submaximal practice to familiarize themselves with the testing apparatus. After&#xD;
      familiarization of testing apparatus, the participant was asked to have three recorded&#xD;
      maximum-effort trials (5 seconds in duration, 60 seconds' rest between trials) for each leg&#xD;
      with uninjured leg tested first.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2016</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">October 20, 2017</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>knee joint angles</measure>
    <time_frame>at 6 months after the surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee flexion in the gait cycle</measure>
    <time_frame>at 6 months after the surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the moment of knee extension in the gait cycle</measure>
    <time_frame>at 6 months after the surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quadriceps strength</measure>
    <time_frame>at 6 months after the surgery.</time_frame>
    <description>Isokinetic muscle strength testing instrument were used to evaluate musle strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>walking speed</measure>
    <time_frame>at 6 months after the surgery.</time_frame>
    <description>Three-dimensional gait analysis system were used during walking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The International Knee Documentation Committee (IKDC) score</measure>
    <time_frame>at 6 months after the 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>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Anterior Cruciate Ligament Injury</condition>
  <arm_group>
    <arm_group_label>ACL group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>command</intervention_name>
    <description>The participant was asked to walk along the walkway while backward counting numbers with increment of seven starting from a randomly given number.</description>
    <arm_group_label>ACL group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-40 years old&#xD;
&#xD;
          -  received unilateral ACL reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  combined with other ligament injuries&#xD;
&#xD;
          -  moderate or severe articular cartilage damage to the patellofemoral and tibiofemoral&#xD;
             joint&#xD;
&#xD;
          -  combined with meniscus injuries that needed to be repaired with a resection or suture&#xD;
&#xD;
          -  other current orthopaedic injuries or disorders that were still affecting lower&#xD;
             extremity movements&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 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>
  <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 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>knee</keyword>
  <keyword>biomechanics</keyword>
  <keyword>walking</keyword>
  <keyword>cognition</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/NCT04461145
org study id: OR002
nct id: NCT04461145
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Individuals who received anterior cruciate ligament (ACL) reconstruction demonstrated lower
      extremity movement asymmetries. The purpose of this study was to determine if psychological
      impairment was a contributor to lower extremity movement asymmetries in walking for
      individuals who received ACL reconstruction.
Background: Anterior cruciate ligament (ACL) reconstruction is a commonly surgical procedure
      to restore knee functions after an ACL injury. Lower extremity movement asymmetries were
      found to be predictive of ACL re-injury and knee OA after ACL reconstruction. Although these
      studies indicated that psychological impairments may contribute to patients' movement
      asymmetries after ACL reconstruction surgery, the effect of psychological impairment on lower
      extremity movement asymmetries has not been confirmed yet.

      Methods: Each participant was asked to wear a pair of black spandex shorts. Passive
      reflective markers were placed bilaterally at the anterior superior iliac spine, posterior
      superior iliac spine, lateral thigh, lateral femoral condyle, medial femoral condyle,
      anterior superior shank, anterior inferior shank, lateral malleoli, medial malleoli, heel,
      and first and fifth metatarsophalangeal. The participant was instructed to walk with barefoot
      in two conditions: (1) without cognitive task (single-task condition), and (2) with
      concurrent cognitive task (dual-task condition). In single-task condition, the participant
      walked along a 10-m walkway at self-selected walking speed. In dual-task condition, the
      participant walked along the walkway while backward counting numbers with an increment of
      seven starting from a randomly given number between 125 and 250. In dual-task condition,
      participants immediately initiated the walking task at their preferred speed once they heard
      the number read by the investigator and kept counting out loudly as required without
      repeating the given number. Participants were asked to count as fast as possible while
      walking task. A 5 min rest was requested between single-task and dual-task test. The order of
      conditions was randomized for the participant. Quadriceps strength was evaluated for the
      participant after walking test.

      Three-dimensional (3-D) trajectories of the reflective markers were collected using an
      8-camera motion capture system (VICON, Oxford, UK) at a sample rate of 100 Hz.
      Ground-reaction force signals were collected using two embedded force plates (AMTI,
      Watertown, Massachusetts) at a sample rate of 1000 Hz. Each participant was asked to have
      three successful trials for each condition. A successful trial was defined as a trial in
      which the participant performed the task as required, and all kinematic and kinetic data were
      collected.

      Quadriceps isometric strength was quantified with an isokinetic dynamometer (CON-TREX MJ;
      Germany) during a maximum voluntary isometric contraction (MVIC). The participant was seated
      with a hip flexed at 90° and knee flexed at 60°. The lateral femoral condyle was aligned with
      the dynamometer axis, and the dynamometer resistance pad was secured to the anterior aspect
      of the distal shank. After correcting for leg weight, the participant was asked to perform
      submaximal practice to familiarize themselves with the testing apparatus. After
      familiarization of testing apparatus, the participant was asked to have three recorded
      maximum-effort trials (5 seconds in duration, 60 seconds' rest between trials) for each leg
      with uninjured leg tested first.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: knee joint angles
time frame: at 6 months after the surgery.
description: Three-dimensional gait analysis system were used during walking.
measure: the moment of knee flexion in the gait cycle
time frame: at 6 months after the surgery.
description: Three-dimensional gait analysis system were used during walking.
measure: the moment of knee extension in the gait cycle
time frame: at 6 months after the surgery.
description: Three-dimensional gait analysis system were used during walking.
measure: quadriceps strength
time frame: at 6 months after the surgery.
description: Isokinetic muscle strength testing instrument were used to evaluate musle strength.
measure: walking speed
time frame: at 6 months after the surgery.
description: Three-dimensional gait analysis system were used during walking.
measure: The International Knee Documentation Committee (IKDC) score
time frame: at 6 months after the 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: ACL group
arm group type: Other
intervention type: Behavioral
intervention name: command
description: The participant was asked to walk along the walkway while backward counting numbers with increment of seven starting from a randomly given number.
arm group label: ACL group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Hongshi Huang, Doctor
role: Study Chair
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Anterior Cruciate Ligament Injuries
sharing ipd: No