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Estimation of Changes in Soft Tissue Rigidity of the Buttocks in Sitting Under Weight Bearing Compared to Sitting Without Weight Bearing

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ClinicalTrials.gov Identifier: NCT03041922
Recruitment Status : Unknown
Verified February 2018 by LEONID CHERVINSKY, HaEmek Medical Center, Israel.
Recruitment status was:  Recruiting
First Posted : February 3, 2017
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
LEONID CHERVINSKY, HaEmek Medical Center, Israel

Study Description
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Brief Summary:

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.


Condition or disease
Changes in Elasticity Duo to Pressure Ulcers in Buttocks

Detailed Description:

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Estimation of Changes in Soft Tissue Rigidity of the Buttocks in Sitting Under Weight Bearing Compared to Sitting Without Weight Bearing
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Groups and Cohorts
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Group/Cohort
Healthy group
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


Outcome Measures
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Primary Outcome Measures :
  1. Elasticity values to be measured by ultrasound device [ Time Frame: Each exam takes about 30 minutes ]
    Elastography software in ultrasound device enable to measure the elasticity of soft tissues in human body in kilo pascal units.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Gender: all Age Limits: above 18 years old Healthy volunteers
Criteria

Inclusion Criteria: healthy volunteers, BMI- 18.5-29.9,

-

Exclusion Criteria:

  • People with neurological deficit
  • people with diabetes
  • people with a BMI above 29.9 or below 18.5
  • pregnant women
  • people with bedsores
  • mental incompetence.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041922


Locations
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Israel
Dr. Leonid Chervinsky Recruiting
'Afula, Israel, 1834111
Contact: Leonid Chervinsky, Doctor    04-6494063    leonid_ch@clalit.org.il   
Contact: Ruba Mansour, BSC    0527430824    rubama@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
More Information
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Additional Information:

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Responsible Party: LEONID CHERVINSKY, Radiologist, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03041922    
Other Study ID Numbers: 0026-16-CMC
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LEONID CHERVINSKY, HaEmek Medical Center, Israel:
Elastography
Buttocks
Ultrasound
Soft tissue
Additional relevant MeSH terms:
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Pressure Ulcer
Thinness
Skin Ulcer
Skin Diseases
Body Weight