BurnsNCT04654572
The Mechanical Properties of Burned Muscles
A study testing Myotonometric measurement in people with Burns and Muscle Loss, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The investigate of mechanical properties of muscles in burned patients. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns, Muscle Loss, Viscoelastic Properties
- What is being tested?
- Myotonometric measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2018to 20 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- burned patient
- major burn over %20 TBSA
Who cannot join
- Amputation
- Dead
- Systemic disease and abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Investigation of Muscle Mechanical Properties in Burned Patients.
The investigate of mechanical properties of muscles in burned patients.
Read the 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.
- Conditions
- Burns, Muscle Loss, Viscoelastic Properties, Stiffness
- Being tested
- Myotonometric measurement
- Keywords
- Burn, muscle, myotonometer, viscoelasticity, stiffness
- Medical subject headings
- Burns, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myotonometric measurementDiagnostic test
Myotonometric assessment can predict the muscle stiffness, tone and elasticity
| Study group | Role | What they receive |
|---|---|---|
| burned group | Experimental | burned patients Receives: Diagnostic Test: Myotonometric measurement |
| control group | Experimental | sedentary people Receives: Diagnostic Test: Myotonometric measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness
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.
Measured: 6 week
Elasticity
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.
Measured: 6 week
Tone
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.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start6 Jun 2018
- Primary completion20 Mar 2019
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Usgu, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654572
- Sponsor's protocol ID
- 2018-05
- Status last verified
- Dec 2020
- First submitted
- 27 Nov 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of myotonometric measurement and physical characteristics of participants will share
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.
PubMed 29017743Porter 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.
PubMed 25390300Ianieri 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.
PubMed 19887038
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Muscle Mechanical Properties in Burned Patients.
- ClinicalTrials.gov ID
- NCT04654572
- Acronym / sponsor ID
- 2018-05
- Conditions
- Burns, Muscle Loss, Viscoelastic Properties, Stiffness
- Keywords
- Burn, muscle, myotonometer, viscoelasticity, stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 20 Mar 2019 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigate of mechanical properties of muscles in burned patients.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| burned group | Experimental | Diagnostic Test: Myotonometric measurementburned patients |
| control group | Experimental | Diagnostic Test: Myotonometric measurementsedentary people |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- burned patient
- major burn over %20 TBSA
Key exclusion criteria (3 listed)
- Amputation
- Dead
- Systemic disease and abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myotonometric measurementMyotonometric assessment can predict the muscle stiffness, tone and elasticity | Diagnostic test | burned group, control group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Background: PubMed 29017743Gittings 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.
- Background: PubMed 25390300Porter 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.
- Background: PubMed 19887038Ianieri 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.
- Individual participant dataSharing planned: Yes. The data of myotonometric measurement and physical characteristics of participants will share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myotonometric measurement in people with Burns and Muscle Loss, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness (time frame: 6 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04654572, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.