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

Changes in Elasticity Duo to Pressure Ulcers in Buttocks Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03041922
• Other study ID #: 0026-16-CMC
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2017
• Last updated: February 25, 2018
• Start date: March 1, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: February 2018
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Changes in Elasticity Duo to Pressure Ulcers in Buttocks
• Pressure Ulcer
• Thinness

Locations

Country	Name	City	State
Israel	Dr. Leonid Chervinsky	`Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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