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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

Study Locations

• Israel
  • 'Afula, Israel, 1834111
    • Recruiting
    • Dr. Leonid Chervinsky
    • Contact: Leonid Chervinsky, Doctor; Phone Number: 04-6494063; Email: leonid_ch@clalit.org.il
    • Contact: Ruba Mansour, BSC; Phone Number: 0527430824; Email: rubama@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Gender: all Age Limits: above 18 years old Healthy volunteers

Description

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

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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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Publications and helpful links

Helpful Links

• reasearch- In Vivo Muscle Stiffening Under Bone Compression Promotes Deep Pressure Sores
• research: The relationship between pressure ulcer incidence and buttock-seat cushion interface pressure in at-risk elderly wheelchair users.
• research: REAL-TIME FINITE ELEMENT MONITORING OF INTERNAL STRESSES IN THE BUTTOCK DURING WHEELCHAIR SITTING TO PREVENT PRESSURE SORES
• research: Use of weight-bearing MRI for evaluating wheelchair cushions based on internal soft-tissue deformations under ischial tuberosities
• research: The effect of mechanical strains in soft tissues of the shoulder during load carriage

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2018
• Last Update Submitted That Met QC Criteria: February 25, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Elastography; Soft tissue; Buttocks
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Body Weight; Pressure Ulcer; Thinness
• Other Study ID Numbers: 0026-16-CMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No