<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/NCT03302832</url>
  </required_header>
  <id_info>
    <org_study_id>313</org_study_id>
    <nct_id>NCT03302832</nct_id>
  </id_info>
  <brief_title>Effectiveness of Reduced Frequency Physical Therapy in Total Knee Arthroplasty</brief_title>
  <official_title>Effectiveness of Reduced Frequency Physical Therapy Supplemented With In-home Exercise Equipment Compared to Standard Care Physical Therapy in Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Campbell University, Incorporated</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Campbell University, Incorporated</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>
      Rehabilitation after Total Knee Arthroplasty surgery involves physical therapy services to&#xD;
      address limitations in range of motion, strength, and participation in normal daily&#xD;
      activities. This investigation will compare the outcomes from standard physical therapy&#xD;
      intervention in comparison to reduced frequency physical therapy sessions supplemented with&#xD;
      in-home exercise equipment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total knee arthroplasty (TKA) is a common surgical procedure for individuals experiencing&#xD;
      pain and reduced physical abilities related to knee pain, most commonly osteoarthritis.&#xD;
      Common physical impairments associated with post-operative TKA rehabilitation include:&#xD;
      reduced knee range of motion (ROM), reduced strength, reduced participation in activities of&#xD;
      daily living, and pain. TKA surgery is routinely paired with physical therapy (PT)&#xD;
      interventions post-operatively in order to facilitate recovery for patients electing to&#xD;
      undergo this intervention. The Total Range Exerciser (T-REX) is a medical device aimed at&#xD;
      reducing the need for post-operative physical therapy services while promoting outcomes.&#xD;
&#xD;
      A successful outcome after total knee arthroplasty requires symptom relief and restoration of&#xD;
      physical function. Measurement of pain and function can be achieved through patient-reported&#xD;
      outcomes measures and objective functional testing. The Knee Injury and Osteoarthritis&#xD;
      Outcome Score (KOOS) is a patient-reported outcomes measure intended to capture the&#xD;
      individual patient's perception of progress throughout the rehabilitative process. Objective&#xD;
      measurements of physical function are necessary to quantify the magnitude of physical&#xD;
      impairment associated with the patient's perceived status. Physical function can be measured&#xD;
      through standardized assessment of knee ROM, strength, and ambulation. The purpose of this&#xD;
      study is to evaluate the effectiveness of standard physical therapy compared to reduced&#xD;
      frequency physical therapy supplemented with the (T-REX) after in total knee arthroplasty in&#xD;
      subjective and objective measurements of physical function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</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>
    <intervention_model_description>Randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>Pre-surgery to 3 months post-surgery</time_frame>
    <description>The KOOS measurement is a patient-reported questionnaire that contains 42 questions covering 5 categories (pain, symptoms, activities of daily living, sports and recreation, and quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported home exercise compliance/adherence</measure>
    <time_frame>1 month post-surgery, 2 months post-surgery, 3 months post-surgery</time_frame>
    <description>Basic questions regarding the percent compliance with home exercises, amount of exercise time per week, and amount of days the participant performed exercise each week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Active Range of Motion (AROM)</measure>
    <time_frame>Pre-surgery to 3 months post-surgery</time_frame>
    <description>Measurement of the range of motion that the participant can perform (in degrees) when maximally bending and straightening the knee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Passive Range of Motion (PROM)</measure>
    <time_frame>Pre-surgery to 3 months post-surgery</time_frame>
    <description>Measurement of the range of motion (in degrees) that the participant's knee can maximally bend and straighten as a result of a manually applied movement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Timed Up-and-Go Test (TUG)</measure>
    <time_frame>Pre-surgery to 3 months post-surgery</time_frame>
    <description>The TUG is a physical performance test that consists of the participant rising from a chair, ambulating 9 meters, turning around, returning to the chair and sitting. It is recorded in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6-minute Walk Test (6MWT)</measure>
    <time_frame>Pre-surgery to 3 months post-surgery</time_frame>
    <description>The 6MWT is an assessment of longer duration ambulation and cardiorespiratory endurance. The test measurement is the total amount of distance that the participant ambulates within a 6-minute period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 30 second Chair Stand Test (30s-CST)</measure>
    <time_frame>Pre-surgery to 3 months post-surgery</time_frame>
    <description>The 30s-CST is a test of strength, endurance and functional balance. The maximum number of sit to stand repetitions performed over a 30 second period represents the score for this test. Pre-test positioning includes placement of a 44 cm (17 inch) chair, measured from floor to seat surface, against a wall to inhibit movement of the chair during the test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Knee Arthritis</condition>
  <condition>Knee Arthropathy</condition>
  <arm_group>
    <arm_group_label>Standard Care Physical Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants randomized to the Standard Care Physical Therapy group will begin outpatient physical therapy services after discharge from inpatient care, on day 4 or 5 post-Total Knee Arthroplasty. The frequency of sessions will be 2-3 x per week for the initial 2 weeks, followed by 2 x per week until the culmination of physical therapy. The frequency and duration of sessions will be determined by the treating physical therapist based upon the clinical needs and progress of the specific participant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physical Therapy and in-Home Equipment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants randomized to the experimental group will begin outpatient physical therapy services after discharge from inpatient care, on day 4 or 5 post-Total Knee Arthroplasty. The frequency of physical therapy sessions will be 1 x per week throughout the duration of the study period. In addition, this group will utilize in-home exercise equipment daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical Therapy</intervention_name>
    <description>Physical therapy includes both the in-person and home-based interventions prescribed for each individual participant in order to maximize overall patient outcomes including: ambulation, range of motion, strength, functional activities, pain, swelling, balance, patient safety, and other items within the scope of physical therapy practice.</description>
    <arm_group_label>Physical Therapy and in-Home Equipment</arm_group_label>
    <arm_group_label>Standard Care Physical Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>In-home Exercise Equipment</intervention_name>
    <description>The in-home exercise component of the study will supplement physical therapy services. This exercise equipment will be utilized daily for up to 90 minutes as guided by the healthcare team</description>
    <arm_group_label>Physical Therapy and in-Home Equipment</arm_group_label>
    <other_name>Total Range Exerciser Arc</other_name>
    <other_name>T-REX Arc</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individual is to undergo TKA by a licensed physician at Participating hospital group&#xD;
&#xD;
          -  Participating primary health insurance provider&#xD;
&#xD;
          -  Patient is &lt; 64.5 years of age&#xD;
&#xD;
          -  Willingness to participate in study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous or current history of cancer&#xD;
&#xD;
          -  High risk for cardiovascular disease as determined by the American College of Sports&#xD;
             Medicine&#xD;
&#xD;
          -  Individuals with documented mental, psychiatric, or emotional disabilities&#xD;
&#xD;
          -  Inability to read and write in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bradley Myers, PT, DPT, DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>EmergeOrtho</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>January 23, 2020</last_update_submitted>
  <last_update_submitted_qc>January 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campbell University, Incorporated</investigator_affiliation>
    <investigator_full_name>Bradley Myers</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Total Knee Arthroplasty</keyword>
  <keyword>Total Knee Replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Joint Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No data is intended to be shared with other researchers</ipd_description>
  </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/NCT03302832
org study id: 313
nct id: NCT03302832
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rehabilitation after Total Knee Arthroplasty surgery involves physical therapy services to
      address limitations in range of motion, strength, and participation in normal daily
      activities. This investigation will compare the outcomes from standard physical therapy
      intervention in comparison to reduced frequency physical therapy sessions supplemented with
      in-home exercise equipment.
Total knee arthroplasty (TKA) is a common surgical procedure for individuals experiencing
      pain and reduced physical abilities related to knee pain, most commonly osteoarthritis.
      Common physical impairments associated with post-operative TKA rehabilitation include:
      reduced knee range of motion (ROM), reduced strength, reduced participation in activities of
      daily living, and pain. TKA surgery is routinely paired with physical therapy (PT)
      interventions post-operatively in order to facilitate recovery for patients electing to
      undergo this intervention. The Total Range Exerciser (T-REX) is a medical device aimed at
      reducing the need for post-operative physical therapy services while promoting outcomes.

      A successful outcome after total knee arthroplasty requires symptom relief and restoration of
      physical function. Measurement of pain and function can be achieved through patient-reported
      outcomes measures and objective functional testing. The Knee Injury and Osteoarthritis
      Outcome Score (KOOS) is a patient-reported outcomes measure intended to capture the
      individual patient's perception of progress throughout the rehabilitative process. Objective
      measurements of physical function are necessary to quantify the magnitude of physical
      impairment associated with the patient's perceived status. Physical function can be measured
      through standardized assessment of knee ROM, strength, and ambulation. The purpose of this
      study is to evaluate the effectiveness of standard physical therapy compared to reduced
      frequency physical therapy supplemented with the (T-REX) after in total knee arthroplasty in
      subjective and objective measurements of physical function.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: Pre-surgery to 3 months post-surgery
description: The KOOS measurement is a patient-reported questionnaire that contains 42 questions covering 5 categories (pain, symptoms, activities of daily living, sports and recreation, and quality of life
measure: Self-reported home exercise compliance/adherence
time frame: 1 month post-surgery, 2 months post-surgery, 3 months post-surgery
description: Basic questions regarding the percent compliance with home exercises, amount of exercise time per week, and amount of days the participant performed exercise each week.
measure: Change in Knee Active Range of Motion (AROM)
time frame: Pre-surgery to 3 months post-surgery
description: Measurement of the range of motion that the participant can perform (in degrees) when maximally bending and straightening the knee.
measure: Change in Knee Passive Range of Motion (PROM)
time frame: Pre-surgery to 3 months post-surgery
description: Measurement of the range of motion (in degrees) that the participant's knee can maximally bend and straighten as a result of a manually applied movement.
measure: Change in Timed Up-and-Go Test (TUG)
time frame: Pre-surgery to 3 months post-surgery
description: The TUG is a physical performance test that consists of the participant rising from a chair, ambulating 9 meters, turning around, returning to the chair and sitting. It is recorded in seconds.
measure: Change in 6-minute Walk Test (6MWT)
time frame: Pre-surgery to 3 months post-surgery
description: The 6MWT is an assessment of longer duration ambulation and cardiorespiratory endurance. The test measurement is the total amount of distance that the participant ambulates within a 6-minute period.
measure: Change in 30 second Chair Stand Test (30s-CST)
time frame: Pre-surgery to 3 months post-surgery
description: The 30s-CST is a test of strength, endurance and functional balance. The maximum number of sit to stand repetitions performed over a 30 second period represents the score for this test. Pre-test positioning includes placement of a 44 cm (17 inch) chair, measured from floor to seat surface, against a wall to inhibit movement of the chair during the test.
arm group label: Standard Care Physical Therapy
arm group type: Active Comparator
description: The participants randomized to the Standard Care Physical Therapy group will begin outpatient physical therapy services after discharge from inpatient care, on day 4 or 5 post-Total Knee Arthroplasty. The frequency of sessions will be 2-3 x per week for the initial 2 weeks, followed by 2 x per week until the culmination of physical therapy. The frequency and duration of sessions will be determined by the treating physical therapist based upon the clinical needs and progress of the specific participant.
arm group label: Physical Therapy and in-Home Equipment
arm group type: Experimental
description: The participants randomized to the experimental group will begin outpatient physical therapy services after discharge from inpatient care, on day 4 or 5 post-Total Knee Arthroplasty. The frequency of physical therapy sessions will be 1 x per week throughout the duration of the study period. In addition, this group will utilize in-home exercise equipment daily.
intervention type: Other
intervention name: Physical Therapy
description: Physical therapy includes both the in-person and home-based interventions prescribed for each individual participant in order to maximize overall patient outcomes including: ambulation, range of motion, strength, functional activities, pain, swelling, balance, patient safety, and other items within the scope of physical therapy practice.
arm group label: Physical Therapy and in-Home Equipment
arm group label: Standard Care Physical Therapy
intervention type: Other
intervention name: In-home Exercise Equipment
description: The in-home exercise component of the study will supplement physical therapy services. This exercise equipment will be utilized daily for up to 90 minutes as guided by the healthcare team
arm group label: Physical Therapy and in-Home Equipment
other name: Total Range Exerciser Arc
other name: T-REX Arc
criteria: 
gender: All
minimum age: N/A
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bradley Myers, PT, DPT, DSc
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Campbell University, Incorporated
investigator full name: Bradley Myers
investigator title: Assistant Professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Joint Diseases
sharing ipd: No
ipd description: No data is intended to be shared with other researchers