<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/NCT03041922</url>
  </required_header>
  <id_info>
    <org_study_id>0026-16-CMC</org_study_id>
    <nct_id>NCT03041922</nct_id>
  </id_info>
  <brief_title>Estimation of Changes in Soft Tissue Rigidity of the Buttocks in Sitting Under Weight Bearing Compared to Sitting Without Weight Bearing</brief_title>
  <official_title>Estimation of Changes in Soft Tissue Rigidity of the Buttocks in Sitting Under Weight Bearing Compared to Sitting Without Weight Bearing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Estimation of Changes in Soft Tissues Elasticity in Buttocks in lying down and sitting&#xD;
      positions by using ultrasound device. the elasticity of fat and muscle tissues will be&#xD;
      measured.&#xD;
&#xD;
      May ultrasound exam helps to predict the development of pressure ulcers in buttocks due to&#xD;
      continuous sitting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the current new research is to check whether Ultrasound device can be used as&#xD;
      a tool for assessing the elasticity of the soft tissues in buttocks and measuring the&#xD;
      elasticity of these tissues with and without bearing weight on a healthy population to set&#xD;
      standards of normal values.&#xD;
&#xD;
      The far purpose of the research is to use ultrasound device for predicting the development of&#xD;
      pressure ulcers.&#xD;
&#xD;
      Population and Methods: In this study, Up to 15 healthy people will participate. Each&#xD;
      participant will pass ultrasound scans of the buttocks, lying down and sitting on a chair&#xD;
      designed for the purpose of research and this after signing an informed consent form.&#xD;
&#xD;
      The process:&#xD;
&#xD;
        1. The participant lies on his stomach on a bed to determine the location of the muscle&#xD;
           that will be marked by a marker.By ultrasound, the investigator measures the thickness&#xD;
           of fat and muscle tissues between the Ischial Tuberosity (ITs) and the skin.&#xD;
&#xD;
        2. The participant sits without bearing weight on a chair built for this study, the seat is&#xD;
           constructed from five straps. Non-weight bearing test is when the straps are far from&#xD;
           the test area, the transducer is placed on the marked place, thickness and elasticity of&#xD;
           muscle tissue and fat will be measured.&#xD;
&#xD;
        3. The participant sits with bearing weight on the chair. weight bearing test is when the&#xD;
           straps are close to the test area , the transducer is placed on the marked place,&#xD;
           thickness and elasticity of muscle tissue and fat will be measured.&#xD;
&#xD;
      After measuring the elasticity of the soft tissues,the data will be analyzed in order to&#xD;
      define ranges of differences between elasticity with and without weight bearing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Elasticity values to be measured by ultrasound device</measure>
    <time_frame>Each exam takes about 30 minutes</time_frame>
    <description>Elastography software in ultrasound device enable to measure the elasticity of soft tissues in human body in kilo pascal units.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Changes in Elasticity Duo to Pressure Ulcers in Buttocks</condition>
  <arm_group>
    <arm_group_label>Healthy group</arm_group_label>
    <description>Every participant passes one ultrasound exam for soft tissues in buttocks in order to measure the elasticity of soft tissues in sitting and lying down positions. This kind of exam may help to predict a development in pressure ulcers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Gender: all Age Limits: above 18 years old Healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: healthy volunteers, BMI- 18.5-29.9,&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People with neurological deficit&#xD;
&#xD;
          -  people with diabetes&#xD;
&#xD;
          -  people with a BMI above 29.9 or below 18.5&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  people with bedsores&#xD;
&#xD;
          -  mental incompetence.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr. Leonid Chervinsky</name>
      <address>
        <city>'Afula</city>
        <zip>1834111</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leonid Chervinsky, Doctor</last_name>
      <phone>04-6494063</phone>
      <email>leonid_ch@clalit.org.il</email>
    </contact>
    <contact_backup>
      <last_name>Ruba Mansour, BSC</last_name>
      <phone>0527430824</phone>
      <email>rubama@clalit.org.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/11295017</url>
    <description>research: The relationship between pressure ulcer incidence and buttock-seat cushion interface pressure in at-risk elderly wheelchair users.</description>
  </link>
  <link>
    <url>http://paloma.eng.tau.ac.il/~msbm/resources/Linder-Ganz-Lisbon-full-final.pdf</url>
    <description>research: REAL-TIME FINITE ELEMENT MONITORING OF INTERNAL STRESSES IN THE BUTTOCK DURING WHEELCHAIR SITTING TO PREVENT PRESSURE SORES</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/26542788</url>
    <description>research: The effect of mechanical strains in soft tissues of the shoulder during load carriage</description>
  </link>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 25, 2018</last_update_submitted>
  <last_update_submitted_qc>February 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>LEONID CHERVINSKY</investigator_full_name>
    <investigator_title>Radiologist</investigator_title>
  </responsible_party>
  <keyword>Elastography</keyword>
  <keyword>Buttocks</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Soft tissue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pressure Ulcer</mesh_term>
    <mesh_term>Thinness</mesh_term>
  </condition_browse>
  <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/NCT03041922
org study id: 0026-16-CMC
nct id: NCT03041922
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Estimation of Changes in Soft Tissues Elasticity in Buttocks in lying down and sitting
      positions by using ultrasound device. the elasticity of fat and muscle tissues will be
      measured.

      May ultrasound exam helps to predict the development of pressure ulcers in buttocks due to
      continuous sitting.
The purpose of the current new research is to check whether Ultrasound device can be used as
      a tool for assessing the elasticity of the soft tissues in buttocks and measuring the
      elasticity of these tissues with and without bearing weight on a healthy population to set
      standards of normal values.

      The far purpose of the research is to use ultrasound device for predicting the development of
      pressure ulcers.

      Population and Methods: In this study, Up to 15 healthy people will participate. Each
      participant will pass ultrasound scans of the buttocks, lying down and sitting on a chair
      designed for the purpose of research and this after signing an informed consent form.

      The process:

        1. The participant lies on his stomach on a bed to determine the location of the muscle
           that will be marked by a marker.By ultrasound, the investigator measures the thickness
           of fat and muscle tissues between the Ischial Tuberosity (ITs) and the skin.

        2. The participant sits without bearing weight on a chair built for this study, the seat is
           constructed from five straps. Non-weight bearing test is when the straps are far from
           the test area, the transducer is placed on the marked place, thickness and elasticity of
           muscle tissue and fat will be measured.

        3. The participant sits with bearing weight on the chair. weight bearing test is when the
           straps are close to the test area , the transducer is placed on the marked place,
           thickness and elasticity of muscle tissue and fat will be measured.

      After measuring the elasticity of the soft tissues,the data will be analyzed in order to
      define ranges of differences between elasticity with and without weight bearing.
observational model: Case-Only
time perspective: Prospective
measure: Elasticity values to be measured by ultrasound device
time frame: Each exam takes about 30 minutes
description: Elastography software in ultrasound device enable to measure the elasticity of soft tissues in human body in kilo pascal units.
arm group label: Healthy group
description: Every participant passes one ultrasound exam for soft tissues in buttocks in order to measure the elasticity of soft tissues in sitting and lying down positions. This kind of exam may help to predict a development in pressure ulcers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
contact backup: 
country: Israel
url: https://www.ncbi.nlm.nih.gov/pubmed/11295017
description: research: The relationship between pressure ulcer incidence and buttock-seat cushion interface pressure in at-risk elderly wheelchair users.
url: http://paloma.eng.tau.ac.il/~msbm/resources/Linder-Ganz-Lisbon-full-final.pdf
description: research: REAL-TIME FINITE ELEMENT MONITORING OF INTERNAL STRESSES IN THE BUTTOCK DURING WHEELCHAIR SITTING TO PREVENT PRESSURE SORES
url: https://www.ncbi.nlm.nih.gov/pubmed/26542788
description: research: The effect of mechanical strains in soft tissues of the shoulder during load carriage
responsible party type: Principal Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: LEONID CHERVINSKY
investigator title: Radiologist
mesh term: Pressure Ulcer
mesh term: Thinness
sharing ipd: No