<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/NCT03243162</url>
  </required_header>
  <id_info>
    <org_study_id>161927</org_study_id>
    <nct_id>NCT03243162</nct_id>
  </id_info>
  <brief_title>Improving ACL Reconstruction Outcomes: CBPT</brief_title>
  <official_title>Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      The overall objective of this study is to conduct a two-group randomized trial to examine the&#xD;
      efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function,&#xD;
      return to sport, and quality of life outcomes in patients following ACL reconstruction&#xD;
      (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral&#xD;
      based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central&#xD;
      hypothesis is that the CBPT-ACLR participants relative to the Education group will&#xD;
      demonstrate significantly greater improvement in postoperative outcomes at 12 months&#xD;
      following surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">April 17, 2020</completion_date>
  <primary_completion_date type="Actual">February 18, 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale</measure>
    <time_frame>Up to 12 months after ACLR surgery</time_frame>
    <description>knee function relating to sport/recreation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Marx Activity Rating Scale</measure>
    <time_frame>Up to 12 months after ACLR surgery</time_frame>
    <description>The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective Patient Outcome for Return to Sports (SPORTS)</measure>
    <time_frame>Up to 12 months after ACLR surgery</time_frame>
    <description>The SPORTS score measures 1) ability to perform the same sport with the same level of effort, 2) ability to reach the same level of performance, and 3) ability to perform with no pain or in spite of the pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale</measure>
    <time_frame>Up to 12 months after ACLR surgery</time_frame>
    <description>knee function relating to quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>Up to 12 months after ACLR surgery</time_frame>
    <description>The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>ACL Injury</condition>
  <condition>ACL - Anterior Cruciate Ligament Rupture</condition>
  <condition>ACL Sprain</condition>
  <condition>ACL Tear</condition>
  <arm_group>
    <arm_group_label>CBPT-ACLR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBPT-ACLR program consisting of weekly phone calls.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Education program consisting of weekly phone calls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBPT-ACLR</intervention_name>
    <description>The CBPT-ACLR program focuses on improving sports function and return to sport. CBPT-ACLR sessions cover realistic expectations, relaxation strategies, problem-solving training, cognitive restructuring, and behavioral self-management (i.e., graded activity, goal setting, managing setbacks and symptom management plans). Each session builds upon the content of the previous session using an action plan and weekly homework is personally tailored based on patient goals. The program consists of one preoperative telephone session and six postoperative telephone sessions with a physical therapist. Each patient randomized into the CBPT-ACLR program will receive a manual to follow along with the study therapist.</description>
    <arm_group_label>CBPT-ACLR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>The education program focuses on postoperative ACLR recovery. Sessions address benefits of physical therapy, proper biomechanics during sports and other functional activity, importance of early exercise after surgery, and ways to promote healing. Education on stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury are also provided. The Education program is matched to the CBPT-ACLR treatment in terms of session frequency, length and contact with the study therapist. Each patient randomized into the Education program will receive a manual to follow along with the study therapist.</description>
    <arm_group_label>Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. English speaking (due to feasibility of employing study personnel to deliver and&#xD;
             assess the study intervention);&#xD;
&#xD;
          2. 14 to 35 years of age (children 14 and older have skeletal maturity and adults 35 and&#xD;
             younger are less likely to have symptoms of knee osteoarthritis);&#xD;
&#xD;
          3. no previous surgery to either knee;&#xD;
&#xD;
          4. time from injury to surgery 12 months or less;&#xD;
&#xD;
          5. active participation in a sport on a weekly basis prior to injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. bilateral simultaneous ACL reconstructions;&#xD;
&#xD;
          2. revision ACLR;&#xD;
&#xD;
          3. any concurrent ligament (MCL, LCL, or PCL) surgical procedures;&#xD;
&#xD;
          4. concurrent osteotomies or meniscus transplantations;&#xD;
&#xD;
          5. surgery secondary to trauma, tumor, or infection;&#xD;
&#xD;
          6. having workman's compensation insurance for surgery;&#xD;
&#xD;
          7. on active military duty;&#xD;
&#xD;
          8. medical history of schizophrenia or other psychotic disorder; and&#xD;
&#xD;
          9. unable to provide stable address and access to a telephone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin Archer, PhD, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Garfield Heights</city>
        <state>Ohio</state>
        <zip>44125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Kristin Archer</investigator_full_name>
    <investigator_title>Associate Professor and Vice Chair of Research</investigator_title>
  </responsible_party>
  <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>
  <!-- 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/NCT03243162
org study id: 161927
nct id: NCT03243162
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of this study is to conduct a two-group randomized trial to examine the
      efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function,
      return to sport, and quality of life outcomes in patients following ACL reconstruction
      (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral
      based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central
      hypothesis is that the CBPT-ACLR participants relative to the Education group will
      demonstrate significantly greater improvement in postoperative outcomes at 12 months
      following surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale
time frame: Up to 12 months after ACLR surgery
description: knee function relating to sport/recreation
measure: Marx Activity Rating Scale
time frame: Up to 12 months after ACLR surgery
description: The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting.
measure: Subjective Patient Outcome for Return to Sports (SPORTS)
time frame: Up to 12 months after ACLR surgery
description: The SPORTS score measures 1) ability to perform the same sport with the same level of effort, 2) ability to reach the same level of performance, and 3) ability to perform with no pain or in spite of the pain.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale
time frame: Up to 12 months after ACLR surgery
description: knee function relating to quality of life
measure: EQ-5D
time frame: Up to 12 months after ACLR surgery
description: The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness.
arm group label: CBPT-ACLR
arm group type: Experimental
description: CBPT-ACLR program consisting of weekly phone calls.
arm group label: Education
arm group type: Active Comparator
description: Education program consisting of weekly phone calls.
intervention type: Behavioral
intervention name: CBPT-ACLR
description: The CBPT-ACLR program focuses on improving sports function and return to sport. CBPT-ACLR sessions cover realistic expectations, relaxation strategies, problem-solving training, cognitive restructuring, and behavioral self-management (i.e., graded activity, goal setting, managing setbacks and symptom management plans). Each session builds upon the content of the previous session using an action plan and weekly homework is personally tailored based on patient goals. The program consists of one preoperative telephone session and six postoperative telephone sessions with a physical therapist. Each patient randomized into the CBPT-ACLR program will receive a manual to follow along with the study therapist.
arm group label: CBPT-ACLR
intervention type: Other
intervention name: Education
description: The education program focuses on postoperative ACLR recovery. Sessions address benefits of physical therapy, proper biomechanics during sports and other functional activity, importance of early exercise after surgery, and ways to promote healing. Education on stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury are also provided. The Education program is matched to the CBPT-ACLR treatment in terms of session frequency, length and contact with the study therapist. Each patient randomized into the Education program will receive a manual to follow along with the study therapist.
arm group label: Education
criteria: 
gender: All
minimum age: 14 Years
maximum age: 35 Years
healthy volunteers: No
last name: Kristin Archer, PhD, DPT
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Kristin Archer
investigator title: Associate Professor and Vice Chair of Research
mesh term: Rupture
mesh term: Anterior Cruciate Ligament Injuries