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

• Conditions: Changes in Elasticity Duo to Pressure Ulcers in Buttocks

• Registration Number: NCT03041922
• Lead Sponsor: HaEmek Medical Center, Israel

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.

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 Timeline

• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Study Start: 2017-03-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-25
• Last Update Posted: 2018-02-27
• Primary Completion: 2018-05-01
• Study Completion: 2018-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Elasticity values to be measured by ultrasound device	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.

Trial Locations

Locations (1)

Dr. Leonid Chervinsky; 🇮🇱 'Afula, Israel