<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/NCT03230942</url>
  </required_header>
  <id_info>
    <org_study_id>UDESantaCatarina</org_study_id>
    <nct_id>NCT03230942</nct_id>
  </id_info>
  <brief_title>Effect of Pre-op Patient Education on Functional Outcomes After TKA</brief_title>
  <official_title>Effect of Pre-operative Patient Education Program on Functional Outcomes After Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the State of Santa Catarina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the State of Santa Catarina</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the effect of preoperative patient education program on&#xD;
      functional mobility, gait, postural control, and kinesiophobia level in subjects with TKA.&#xD;
      Patients of both gender will be recruited unilaterally in the city of Florianopolis and&#xD;
      referred by an orthopedist to the Physiotherapy Clinic of UDESC. They are divided into two&#xD;
      groups: one that will receive verbal guidance and a booklet with related information such as&#xD;
      your physical condition as well as signs and symptoms in the postoperative period and a group&#xD;
      that will receive only verbal guidance.Both groups will be evaluated by a blind evaluator in&#xD;
      the preoperative and postoperative periods (6 weeks and 6 months). The evaluations will be&#xD;
      divided into five stages. Anthropometric measurements of the individual will be made and then&#xD;
      the WOMAC functionality questionnaire and the Kinesiophobia Cover Scale will be applied.Then&#xD;
      the individual will walk for 5 meters for three-dimensional gait analysis and&#xD;
      electromyographic analysis of the quadriceps and femoral biceps. The evaluation of functional&#xD;
      mobility by Timed Up And Go and assessment of postural control in an equilibrium platform&#xD;
      will also be performed. Statistical data will be analyzed by analysis of variance 3x2&#xD;
      considering factor time (pre, post 6 weeks and post 6 months) and groups (with and without&#xD;
      information leaflet). The value of p will be 0.05.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be developed in the dependencies of the Laboratory of Biomechanics of the&#xD;
      Center for Health Sciences and Sports of UDESC. In the preoperative period the subjects will&#xD;
      be informed about their physical conditions as well as signs and symptoms of the&#xD;
      postoperative period. One group (GI) will receive this information verbally and one leaflet&#xD;
      while the other group (GC) will receive only verbal information. The allocation in these&#xD;
      groups will be through a lottery, carried out by a member of the team who will not&#xD;
      participate in the evaluation stages.&#xD;
&#xD;
      This staff member will read the booklet individually for each GI participant, in a reserved&#xD;
      room, before handing out the leaflet to take home. GI participants will be encouraged to&#xD;
      reread the information in the home environment and will be asked about the completion of this&#xD;
      in the following steps by the staff member responsible for the blinding.&#xD;
&#xD;
      All participants included in the study will perform the kinematic, kinetic and&#xD;
      electromyographic gait analysis as well as evaluation of fear of movement, functional&#xD;
      mobility and self-perceived functionality in the pre (baseline)-and postoperative period (6&#xD;
      weeks and after 6 months).&#xD;
&#xD;
      The total duration of each evaluation will be approximately 2 (two) hours and 30 (thirty)&#xD;
      minutes and all collections will be carried out by the same team. The participant will be&#xD;
      allowed to stop the test if they feel pain or become fatigued.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">July 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>All patients will be assessed for functional outcomes by a rater blinded to the study arm</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Timed up And Go Test score</measure>
    <time_frame>pre-operative; 6 weeks; 6 months</time_frame>
    <description>The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible. The TUG has good inter-rater and intra-rater reliability and validity for functional testing in older adults at risk for falls. The test is easy to administer and can be completed in two to three minutes.Change from baseline (pre-operative) in the functional mobility. The variable will be measured in seconds.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EMG activity</measure>
    <time_frame>pre-operative; 6 weeks; 6 months</time_frame>
    <description>Electromyographic activity of rectus femoris, vastus lateralis, vastus medialis, vastus medial and gastrocnemius by NORAXON WIRELESS EMG. Change from baseline (pre-operative).The variable will be measured in % of maximal voluntary contraction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinematics</measure>
    <time_frame>pre-operative; 6 weeks; 6 months</time_frame>
    <description>Gait analysis by VICON three-dimensional ,10-camera motion capture system.The outcome measurement is assessed at pre-operation, six weeks and six month after operation. Change from baseline (pre-operative). The variable will be measured in degrees.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinetics</measure>
    <time_frame>pre-operative; 6 weeks; 6 months</time_frame>
    <description>Gait analysis by AMTI plate force. The outcome measurement is assessed at pre-operation, six weeks and six month after operation. Change from baseline (pre-operative). The variable will be measured in newtons</description>
  </secondary_outcome>
  <other_outcome>
    <measure>kinesiophobia</measure>
    <time_frame>pre-operative; 6 weeks; 6 months</time_frame>
    <description>Fear of movement. The variable will be measured in points (score).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Knee Arthropathy</condition>
  <arm_group>
    <arm_group_label>Patient education program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-operative education and pos-operative rehabilitation in individuals will be undergo knee arthroplasty.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control - only pos-op rehabilitation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pos-operative rehabilitation in individuals will be undergo knee arthroplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-operative education</intervention_name>
    <description>Verbal and booklet about symptoms and physical conditions pos knee replacement</description>
    <arm_group_label>Patient education program</arm_group_label>
    <other_name>Patient education program</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pos-operative rehabilitation</intervention_name>
    <description>Physical therapy treatment</description>
    <arm_group_label>Control - only pos-op rehabilitation</arm_group_label>
    <arm_group_label>Patient education program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Literate;&#xD;
&#xD;
          -  Elective submission of unilateral total knee arthroplasty (TKA) due to osteoarthrosis&#xD;
&#xD;
          -  Individuals without other arthroplasties in the lower limb in the last 6 months;&#xD;
&#xD;
          -  Range of motion greater than 90 degrees or operated contralateral knee.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated condition that impedes performance in gait tests, including significant&#xD;
             osteoarthrosis in the contralateral knee or hips (defined as pain greater than or&#xD;
             equal to 5 on the analog visual pain scale);&#xD;
&#xD;
          -  Absence or abandonment in the study follow-up sessions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilmar M Santos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of State of Santa Catarina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Health and Sport Sciences</name>
      <address>
        <city>Florianópolis</city>
        <state>Santa Catarina</state>
        <zip>88080350</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of the State of Santa Catarina</investigator_affiliation>
    <investigator_full_name>Gilmar Moraes Santos</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>patient education</keyword>
  <keyword>arthritis</keyword>
  <keyword>knee</keyword>
  <keyword>arthroplasty</keyword>
  <keyword>gait</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03230942/ICF_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03230942/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03230942/Prot_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03230942
org study id: UDESantaCatarina
nct id: NCT03230942
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of preoperative patient education program on
      functional mobility, gait, postural control, and kinesiophobia level in subjects with TKA.
      Patients of both gender will be recruited unilaterally in the city of Florianopolis and
      referred by an orthopedist to the Physiotherapy Clinic of UDESC. They are divided into two
      groups: one that will receive verbal guidance and a booklet with related information such as
      your physical condition as well as signs and symptoms in the postoperative period and a group
      that will receive only verbal guidance.Both groups will be evaluated by a blind evaluator in
      the preoperative and postoperative periods (6 weeks and 6 months). The evaluations will be
      divided into five stages. Anthropometric measurements of the individual will be made and then
      the WOMAC functionality questionnaire and the Kinesiophobia Cover Scale will be applied.Then
      the individual will walk for 5 meters for three-dimensional gait analysis and
      electromyographic analysis of the quadriceps and femoral biceps. The evaluation of functional
      mobility by Timed Up And Go and assessment of postural control in an equilibrium platform
      will also be performed. Statistical data will be analyzed by analysis of variance 3x2
      considering factor time (pre, post 6 weeks and post 6 months) and groups (with and without
      information leaflet). The value of p will be 0.05.
The study will be developed in the dependencies of the Laboratory of Biomechanics of the
      Center for Health Sciences and Sports of UDESC. In the preoperative period the subjects will
      be informed about their physical conditions as well as signs and symptoms of the
      postoperative period. One group (GI) will receive this information verbally and one leaflet
      while the other group (GC) will receive only verbal information. The allocation in these
      groups will be through a lottery, carried out by a member of the team who will not
      participate in the evaluation stages.

      This staff member will read the booklet individually for each GI participant, in a reserved
      room, before handing out the leaflet to take home. GI participants will be encouraged to
      reread the information in the home environment and will be asked about the completion of this
      in the following steps by the staff member responsible for the blinding.

      All participants included in the study will perform the kinematic, kinetic and
      electromyographic gait analysis as well as evaluation of fear of movement, functional
      mobility and self-perceived functionality in the pre (baseline)-and postoperative period (6
      weeks and after 6 months).

      The total duration of each evaluation will be approximately 2 (two) hours and 30 (thirty)
      minutes and all collections will be carried out by the same team. The participant will be
      allowed to stop the test if they feel pain or become fatigued.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: All patients will be assessed for functional outcomes by a rater blinded to the study arm
measure: Timed up And Go Test score
time frame: pre-operative; 6 weeks; 6 months
description: The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible. The TUG has good inter-rater and intra-rater reliability and validity for functional testing in older adults at risk for falls. The test is easy to administer and can be completed in two to three minutes.Change from baseline (pre-operative) in the functional mobility. The variable will be measured in seconds.
measure: EMG activity
time frame: pre-operative; 6 weeks; 6 months
description: Electromyographic activity of rectus femoris, vastus lateralis, vastus medialis, vastus medial and gastrocnemius by NORAXON WIRELESS EMG. Change from baseline (pre-operative).The variable will be measured in % of maximal voluntary contraction.
measure: Kinematics
time frame: pre-operative; 6 weeks; 6 months
description: Gait analysis by VICON three-dimensional ,10-camera motion capture system.The outcome measurement is assessed at pre-operation, six weeks and six month after operation. Change from baseline (pre-operative). The variable will be measured in degrees.
measure: Kinetics
time frame: pre-operative; 6 weeks; 6 months
description: Gait analysis by AMTI plate force. The outcome measurement is assessed at pre-operation, six weeks and six month after operation. Change from baseline (pre-operative). The variable will be measured in newtons
measure: kinesiophobia
time frame: pre-operative; 6 weeks; 6 months
description: Fear of movement. The variable will be measured in points (score).
arm group label: Patient education program
arm group type: Experimental
description: Pre-operative education and pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
arm group label: Control - only pos-op rehabilitation
arm group type: Active Comparator
description: Pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
intervention type: Other
intervention name: Pre-operative education
description: Verbal and booklet about symptoms and physical conditions pos knee replacement
arm group label: Patient education program
other name: Patient education program
intervention type: Other
intervention name: Pos-operative rehabilitation
description: Physical therapy treatment
arm group label: Control - only pos-op rehabilitation
arm group label: Patient education program
criteria: 
gender: All
minimum age: 55 Years
maximum age: 90 Years
healthy volunteers: No
last name: Gilmar M Santos, PhD
role: Principal Investigator
affiliation: University of State of Santa Catarina
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of the State of Santa Catarina
investigator full name: Gilmar Moraes Santos
investigator title: PhD
mesh term: Joint Diseases
provided document: 
provided document: 
provided document: 