Muscle LossNCT04289129
The Viscoelastic Properties of Lower Extremity's Muscles
A study testing Myotonometric evaluation in people with Muscle Loss, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to create normative values for stiffness, tonus and elasticity in the lower extremity muscles and to determine age and gender differences. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Loss
- What is being tested?
- Myotonometric evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2018to 20 Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals without any systemic or metabolic diseases, psychological illnesses, or drug abuse; those without any diseases that could cause muscle disease or muscle atrophy; and those who had not undergone any surgery in the musculoskeletal system during the past 3 months were included
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Mechanical Characteristics of Lower Extremity Muscles in Healthy Individuals Using Myotonometric Assessment
This study aims to create normative values for stiffness, tonus and elasticity in the lower extremity muscles and to determine age and gender differences.
- Conditions
- Muscle Loss
- Being tested
- Myotonometric evaluation
- Keywords
- Muscle tone, viscoelastic properties, aging
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myotonometric evaluationDiagnostic test
Vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.
| Study group | Role | What they receive |
|---|---|---|
| men | Experimental | Not described Receives: Diagnostic Test: Myotonometric evaluation |
| women | Experimental | Not described Receives: Diagnostic Test: Myotonometric evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myotonometric evaluation
The muscle tone, stiffness and elasticity of participants are assessed with myoton device for creating normative data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start6 Jun 2018
- Primary completion12 Jan 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle LossStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 389 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
- NCT04289129
- Sponsor's protocol ID
- 2019-61
- Status last verified
- Dec 2020
- First submitted
- 23 Feb 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Correa-de-Araujo R, Harris-Love MO, Miljkovic I, Fragala MS, Anthony BW, Manini TM. The Need for Standardized Assessment of Muscle Quality in Skeletal Muscle Function Deficit and Other Aging-Related Muscle Dysfunctions: A Symposium Report. Front Physiol. 2017 Feb 15;8:87. doi: 10.3389/fphys.2017.00087. eCollection 2017.
PubMed 28261109Perkisas, S., et al., Physiological and architectural changes in the ageing muscle and their relation to strength and function in sarcopenia. European Geriatric Medicine, 2016. 7(3): p. 201-206
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanical Characteristics of Lower Extremity Muscles in Healthy Individuals Using Myotonometric Assessment
- ClinicalTrials.gov ID
- NCT04289129
- Acronym / sponsor ID
- 2019-61
- Conditions
- Muscle Loss
- Keywords
- Muscle tone, viscoelastic properties, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 12 Jan 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 28 Feb 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.
This study aims to create normative values for stiffness, tonus and elasticity in the lower extremity muscles and to determine age and gender differences.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| men | Experimental | Diagnostic Test: Myotonometric evaluation |
| women | Experimental | Diagnostic Test: Myotonometric evaluation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals without any systemic or metabolic diseases, psychological illnesses, or drug abuse; those without any diseases that could cause muscle disease or muscle atrophy; and those who had not undergone any surgery in the musculoskeletal system during the past 3 months were included
Key exclusion criteria (1 listed)
- -
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 evaluationVertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations. | Diagnostic test | men, women |
Primary outcome
Myotonometric evaluation
Time frame: 1 year
The muscle tone, stiffness and elasticity of participants are assessed with myoton device for creating normative data
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 17 Dec 2020.
- Results publication: PubMed 28261109Correa-de-Araujo R, Harris-Love MO, Miljkovic I, Fragala MS, Anthony BW, Manini TM. The Need for Standardized Assessment of Muscle Quality in Skeletal Muscle Function Deficit and Other Aging-Related Muscle Dysfunctions: A Symposium Report. Front Physiol. 2017 Feb 15;8:87. doi: 10.3389/fphys.2017.00087. eCollection 2017.
- Results publicationPerkisas, S., et al., Physiological and architectural changes in the ageing muscle and their relation to strength and function in sarcopenia. European Geriatric Medicine, 2016. 7(3): p. 201-206
- Individual participant dataSharing planned: Undecided
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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 evaluation in people with 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 1 inclusion and 1 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 17 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?
Myotonometric evaluation (time frame: 1 year). 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 NCT04289129, which also lists 2 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 17 Dec 2020.