<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/NCT03304561</url>
  </required_header>
  <id_info>
    <org_study_id>123456</org_study_id>
    <nct_id>NCT03304561</nct_id>
  </id_info>
  <brief_title>The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction</brief_title>
  <official_title>Contralateral Strength Training Effects on Functional Outcomes in Patients Who Had Undergone ACL Reconstruction: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL&#xD;
      reconstruction and one of the main focus of rehabilitation is to improve strenght of these&#xD;
      muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to&#xD;
      improve the strenght of the quadriceps&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Returning to sport after ACL reconstruction is not at desired level among athletes.&#xD;
      Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL&#xD;
      reconstruction. Cross-over training is recomended during rehabilitation after ACL&#xD;
      reconstrucion. Yet duration of the training, frequancy and type of exercise interention are&#xD;
      not clear for the cross-over training. Ain of the study is to investigate the effects of&#xD;
      cross-over training on muscle strenght&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>quadriceps and hamstring muscle strenght</measure>
    <time_frame>6 month</time_frame>
    <description>quadriceps strength change during the first, second and sixth months of the rehabilitation proccess after ACL reconstruction surgery. the strength measurements will conducted on isokinetic dynamometer (isomed 2000)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>functional outcomes</measure>
    <time_frame>6 month</time_frame>
    <description>one leg hop test, vertical jump test on the sixth month after surgery. the functional outcomes will be measured only at the sixth month after surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Anterior Cruciate Ligament Reconstruction</condition>
  <arm_group>
    <arm_group_label>traditional rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in this groups is going to recieve traditional rehabilitation programme for 3 months after ACL recontsruction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cross-over training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients in this programme is going to recieve isokinetic exercise programme targeting unilvolved limb during rehabilitation. for the first 4 weeks after ACL reconstruction traditional rehabiitation programme is going to applied to the subjects. after 4 weeks, isokinetic strenghtening programme at 60˚/second angular velocity, between 0-90 degree knee flexion until 3 months after ACL reconstructon</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional rehabilitation</intervention_name>
    <description>traditional ACL rehabilitation program</description>
    <arm_group_label>traditional rehabilitation</arm_group_label>
    <other_name>Standard post-operative ACL rehabilidation program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cross-over training</intervention_name>
    <description>Cross-over training addition to the traditional rehabilidation</description>
    <arm_group_label>Cross-over training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having surgery of ACL reconstruction on one side&#xD;
&#xD;
          -  having no problem at least six month on the nonsrgical side&#xD;
&#xD;
          -  recieving the rehabilitation programme at hacettepe university, physiotherapy&#xD;
             department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusing to include to the study&#xD;
&#xD;
          -  having revision ACL surgery&#xD;
&#xD;
          -  addition of PCL or cartilage surgery addition to the ACL surgery&#xD;
&#xD;
          -  not participating to the rehabilidation program regularly over 3 month after sugery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>volga tunay, PhD</last_name>
    <role>Study Director</role>
    <affiliation>volgamel@yahoo.com</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sports Physiotherapy Unit</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>January 31, 2018</last_update_submitted>
  <last_update_submitted_qc>January 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>GULCAN HARPUT</investigator_full_name>
    <investigator_title>Phd</investigator_title>
  </responsible_party>
  <keyword>knee</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>ACL</keyword>
  <keyword>Contralateral training</keyword>
  <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/NCT03304561
org study id: 123456
nct id: NCT03304561
lead sponsor: 
has dmc: Yes
Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL
      reconstruction and one of the main focus of rehabilitation is to improve strenght of these
      muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to
      improve the strenght of the quadriceps
Returning to sport after ACL reconstruction is not at desired level among athletes.
      Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL
      reconstruction. Cross-over training is recomended during rehabilitation after ACL
      reconstrucion. Yet duration of the training, frequancy and type of exercise interention are
      not clear for the cross-over training. Ain of the study is to investigate the effects of
      cross-over training on muscle strenght
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: quadriceps and hamstring muscle strenght
time frame: 6 month
description: quadriceps strength change during the first, second and sixth months of the rehabilitation proccess after ACL reconstruction surgery. the strength measurements will conducted on isokinetic dynamometer (isomed 2000)
measure: functional outcomes
time frame: 6 month
description: one leg hop test, vertical jump test on the sixth month after surgery. the functional outcomes will be measured only at the sixth month after surgery.
arm group label: traditional rehabilitation
arm group type: Experimental
description: patients in this groups is going to recieve traditional rehabilitation programme for 3 months after ACL recontsruction
arm group label: Cross-over training
arm group type: Experimental
description: patients in this programme is going to recieve isokinetic exercise programme targeting unilvolved limb during rehabilitation. for the first 4 weeks after ACL reconstruction traditional rehabiitation programme is going to applied to the subjects. after 4 weeks, isokinetic strenghtening programme at 60˚/second angular velocity, between 0-90 degree knee flexion until 3 months after ACL reconstructon
intervention type: Other
intervention name: Traditional rehabilitation
description: traditional ACL rehabilitation program
arm group label: traditional rehabilitation
other name: Standard post-operative ACL rehabilidation program
intervention type: Other
intervention name: Cross-over training
description: Cross-over training addition to the traditional rehabilidation
arm group label: Cross-over training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: volga tunay, PhD
role: Study Director
affiliation: volgamel@yahoo.com
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: GULCAN HARPUT
investigator title: Phd
sharing ipd: No