The Mechanical Properties of Burned Muscles

December 14, 2020 updated by: Serkan Usgu, Hasan Kalyoncu University

The Investigation of Muscle Mechanical Properties in Burned Patients.

The investigate of mechanical properties of muscles in burned patients.

Study Overview

Detailed Description

The hypermetabolic response to severe burn is characterized by muscle protein catabolism. Current opinion states that the hypermetabolic state resolves soon after complete wound closure. Clinically, we have witnessed that burned patient appear to be hypermetabolic and catabolic long after full healing of their wounds. Our goal in this study was to determine muscle mechanical properties (tone, stiffness and elasticity) after burn.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gaziantep, Turkey, 27144
        • Hasan Kalyoncu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • burned patient
  • major burn over %20 TBSA

Exclusion Criteria:

  • Amputation
  • Dead
  • Systemic disease and abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: burned group
burned patients
Myotonometric assessment can predict the muscle stiffness, tone and elasticity
Experimental: control group
sedentary people
Myotonometric assessment can predict the muscle stiffness, tone and elasticity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stiffness
Time Frame: 6 week
Myotonometric measurement was used to determine for muscle stiffness. Device has a probe that creates constant pre-excitations and generates short-term, low-force mechanical stimulations over skin. The stimulations induce damped natural oscillations in the tissue and the myoton device records these oscillations with an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device.
6 week
Elasticity
Time Frame: 6 week
Myotonometric measurement was used to determine for muscle elasticity. Device has a probe that creates constant pre-excitations and generates short-term, low-force mechanical stimulations over skin. The stimulations induce damped natural oscillations in the tissue and the myoton device records these oscillations with an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device.
6 week
Tone
Time Frame: 6 week
Myotonometric measurement was used to determine for muscle tone. Device has a probe that creates constant pre-excitations and generates short-term, low-force mechanical stimulations over skin. The stimulations induce damped natural oscillations in the tissue and the myoton device records these oscillations with an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device.
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2018

Primary Completion (Actual)

March 20, 2019

Study Completion (Actual)

August 20, 2020

Study Registration Dates

First Submitted

November 27, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 14, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data of myotonometric measurement and physical characteristics of participants will share

IPD Sharing Time Frame

after publication and 10 years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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