Clinical trial NCT03041922: Estimation of Changes in Soft Tissue Rigidity of the Buttocks in Sitting Under Weight Bearing Compared to Sitting Without Weight Bearing
Official title: Estimation of Changes in Soft Tissue Rigidity of the Buttocks in Sitting Under Weight Bearing Compared to Sitting Without Weight Bearing
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Changes in Elasticity Duo to Pressure Ulcers in Buttocks
Keywords: Elastography
Buttocks
Ultrasound
Soft tissue
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gender: all Age Limits: above 18 years old Healthy volunteers

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Elasticity values to be measured by ultrasound device
timeFrame: Each exam takes about 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: 'Afula
country: Israel
facility: Dr. Leonid Chervinsky
Study officials:
References: