- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04654572
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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.
General Publications
- Gittings PM, Grisbrook TL, Edgar DW, Wood FM, Wand BM, O'Connell NE. Resistance training for rehabilitation after burn injury: A systematic literature review & meta-analysis. Burns. 2018 Jun;44(4):731-751. doi: 10.1016/j.burns.2017.08.009. Epub 2017 Oct 7. Erratum In: Burns. 2020 Aug;46(5):1240-1241.
- Porter C, Hardee JP, Herndon DN, Suman OE. The role of exercise in the rehabilitation of patients with severe burns. Exerc Sport Sci Rev. 2015 Jan;43(1):34-40. doi: 10.1249/JES.0000000000000029.
- Ianieri G, Saggini R, Marvulli R, Tondi G, Aprile A, Ranieri M, Benedetto G, Altini S, Lancioni GE, Goffredo L, Bellomo RG, Megna M, Megna G. New approach in the assessment of the tone, elasticity and the muscular resistance: nominal scales vs MYOTON. Int J Immunopathol Pharmacol. 2009 Jul-Sep;22(3 Suppl):21-4. doi: 10.1177/03946320090220S304. No abstract available.
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
Keywords
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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