<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/NCT02975531</url>
  </required_header>
  <id_info>
    <org_study_id>0121.0.237.00007</org_study_id>
    <nct_id>NCT02975531</nct_id>
  </id_info>
  <brief_title>Simulator of Pompage Technique for Physiotherapists</brief_title>
  <official_title>Simulator of Pompage Technique for Education and Training of Physiotherapists</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mogi das Cruzes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mogi das Cruzes</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parameterize the Pompage technique with an anatomical model cervical region to simulate&#xD;
      specific procedures. Quantify the times, displacements, and facilitate the training of&#xD;
      students and professional of physical therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Manual techniques are taught and trained with practical demonstration without technology&#xD;
      support to measure them, so they are difficult to reproduce. This difficulty increases in&#xD;
      Pompage technique because the student is not able to estimate the displacement on the skin.&#xD;
      In this research, to parameterize and train the technique was developed and validated an&#xD;
      anatomical model of the cervical region, with silicone and latex rubber. The anatomical model&#xD;
      simulates the soft tissues and a plastic resin structure represents the cervical spine bone.&#xD;
      An optical sensor was used to measure the displacements performed on simulated skin versus&#xD;
      time. The Likert scale was used for assessing the similarity of the anatomical model relative&#xD;
      to the size, shape, texture, elasticity and displacement of the skin as well as the curvature&#xD;
      of the cervical spine. Five experienced professionals (GP) in the technical performed five&#xD;
      series of Pompage technique. With the mean of data collected were determined benchmarks for&#xD;
      technical and implemented in a standard guide to train the volunteers. Twenty-six volunteers&#xD;
      (GE) with no experience performed the Pompage technique, with the anatomical model following&#xD;
      the standard guide. A physical therapist (VE) was selected to evaluate the volunteers (GE)&#xD;
      before and after training in the simulator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">April 2008</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Displacement of the skin</measure>
    <time_frame>5 days</time_frame>
    <description>The displacement of the skin (mm) of the volunteers VF and GT was measured to validated the simulator. The volunteers GE used the simulator and the displacement of the skin of simulator was measured during the Pompage technique.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pressure</measure>
    <time_frame>5 days</time_frame>
    <description>The volunteers GE used the simulator and the pressure (mm/Hg ) on the simulator was measured during the Pompage technique.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cytometry neck</measure>
    <time_frame>1 minute</time_frame>
    <description>The cytometry neck (cm) of the volunteers VF and GT was measure to validated the simulator.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Musculoskeletal Pain</condition>
  <condition>Contracture</condition>
  <arm_group>
    <arm_group_label>Simulator's construction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To build the simulator was selected a volunteer (VF) as a model. This volunteer had no complaints of pain or trauma to the cervical region. This region was used to collect the displacement of the skin and cytometry neck.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Model Features</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thirty-nine volunteers (GT) were selected men and women aged over 18 years without history of trauma in the cervical region in order to determine the characteristics of the model: skin elasticity and cirtometry neck.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parameterization technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five physiotherapists (GP) with at least 5 years of experience in the technique were selected to perform the technique on the simulator and complete a questionnaire in order to evaluate the texture and skin elasticity, the curvature and size of the cervical spine format. They scored these items from the Likert scale. After evaluation they used the simulator to generate a standard guide training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simulator training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twenty-six volunteers (GE) were selected, men and women, aged over 18 years without prior knowledge of the technique for simulator training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Training Evaluation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simulator's construction</intervention_name>
    <description>Model to build the mold for the simulator</description>
    <arm_group_label>Simulator's construction</arm_group_label>
    <other_name>VF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Model Features</intervention_name>
    <description>Volunteers to determine the elasticity of the skin and cirtometry neck to compare with the simulator.</description>
    <arm_group_label>Model Features</arm_group_label>
    <other_name>GT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parameterization technique</intervention_name>
    <description>Evaluation of the simulator features and parameterization of the Pompage technique in the simulator.</description>
    <arm_group_label>Parameterization technique</arm_group_label>
    <other_name>GP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simulator training</intervention_name>
    <description>Training of pompage technique using the simulator.</description>
    <arm_group_label>Simulator training</arm_group_label>
    <other_name>GE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training Evaluation</intervention_name>
    <description>Evaluation of volunteers from GE group before and after training with the simulator.</description>
    <arm_group_label>Training Evaluation</arm_group_label>
    <other_name>VE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no history of cervical trauma (GT and VF)&#xD;
&#xD;
          -  Do not have dermatitis in the cervical region (GT and VF)&#xD;
&#xD;
          -  recurrent migraines (GT and VF)&#xD;
&#xD;
          -  no prior knowledge of Pompage technique (GE).&#xD;
&#xD;
          -  minimum 5 years experience of applying the Pompage technique (GP and VE).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  report pain in the cervical region (GT and VF)&#xD;
&#xD;
          -  irritations in the cervical region (GT and VF)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annie F. Frère, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mogi das Cruzes</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>March 9, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Mogi das Cruzes</investigator_affiliation>
    <investigator_full_name>Annie France Frère Slaets</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Pompage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <mesh_term>Contracture</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02975531
org study id: 0121.0.237.00007
nct id: NCT02975531
lead sponsor: 
has dmc: Yes
Parameterize the Pompage technique with an anatomical model cervical region to simulate
      specific procedures. Quantify the times, displacements, and facilitate the training of
      students and professional of physical therapy.
Manual techniques are taught and trained with practical demonstration without technology
      support to measure them, so they are difficult to reproduce. This difficulty increases in
      Pompage technique because the student is not able to estimate the displacement on the skin.
      In this research, to parameterize and train the technique was developed and validated an
      anatomical model of the cervical region, with silicone and latex rubber. The anatomical model
      simulates the soft tissues and a plastic resin structure represents the cervical spine bone.
      An optical sensor was used to measure the displacements performed on simulated skin versus
      time. The Likert scale was used for assessing the similarity of the anatomical model relative
      to the size, shape, texture, elasticity and displacement of the skin as well as the curvature
      of the cervical spine. Five experienced professionals (GP) in the technical performed five
      series of Pompage technique. With the mean of data collected were determined benchmarks for
      technical and implemented in a standard guide to train the volunteers. Twenty-six volunteers
      (GE) with no experience performed the Pompage technique, with the anatomical model following
      the standard guide. A physical therapist (VE) was selected to evaluate the volunteers (GE)
      before and after training in the simulator.
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Displacement of the skin
time frame: 5 days
description: The displacement of the skin (mm) of the volunteers VF and GT was measured to validated the simulator. The volunteers GE used the simulator and the displacement of the skin of simulator was measured during the Pompage technique.
measure: Pressure
time frame: 5 days
description: The volunteers GE used the simulator and the pressure (mm/Hg ) on the simulator was measured during the Pompage technique.
measure: Cytometry neck
time frame: 1 minute
description: The cytometry neck (cm) of the volunteers VF and GT was measure to validated the simulator.
arm group label: Simulator's construction
arm group type: Experimental
description: To build the simulator was selected a volunteer (VF) as a model. This volunteer had no complaints of pain or trauma to the cervical region. This region was used to collect the displacement of the skin and cytometry neck.
arm group label: Model Features
arm group type: Experimental
description: Thirty-nine volunteers (GT) were selected men and women aged over 18 years without history of trauma in the cervical region in order to determine the characteristics of the model: skin elasticity and cirtometry neck.
arm group label: Parameterization technique
arm group type: Experimental
description: Five physiotherapists (GP) with at least 5 years of experience in the technique were selected to perform the technique on the simulator and complete a questionnaire in order to evaluate the texture and skin elasticity, the curvature and size of the cervical spine format. They scored these items from the Likert scale. After evaluation they used the simulator to generate a standard guide training.
arm group label: Simulator training
arm group type: Experimental
description: Twenty-six volunteers (GE) were selected, men and women, aged over 18 years without prior knowledge of the technique for simulator training.
arm group label: Training Evaluation
arm group type: Experimental
description: A physical therapist (VE) was selected to evaluate the volunteers (GE) before and after training in the simulator.
intervention type: Other
intervention name: Simulator's construction
description: Model to build the mold for the simulator
arm group label: Simulator's construction
other name: VF
intervention type: Other
intervention name: Model Features
description: Volunteers to determine the elasticity of the skin and cirtometry neck to compare with the simulator.
arm group label: Model Features
other name: GT
intervention type: Other
intervention name: Parameterization technique
description: Evaluation of the simulator features and parameterization of the Pompage technique in the simulator.
arm group label: Parameterization technique
other name: GP
intervention type: Other
intervention name: Simulator training
description: Training of pompage technique using the simulator.
arm group label: Simulator training
other name: GE
intervention type: Other
intervention name: Training Evaluation
description: Evaluation of volunteers from GE group before and after training with the simulator.
arm group label: Training Evaluation
other name: VE
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Annie F. Frère, PhD
role: Principal Investigator
affiliation: University of Mogi das Cruzes
responsible party type: Principal Investigator
investigator affiliation: University of Mogi das Cruzes
investigator full name: Annie France Frère Slaets
investigator title: PhD
mesh term: Musculoskeletal Pain
mesh term: Contracture
sharing ipd: Yes