Muscular ToneNCT05183659
The Reliability of Myotonometer in Evaluating the Muscle Tone and Biomechanical Properties of the Forearm Muscles
An observational study of Muscular Tone and Viscoelasticity, run by İlke KARA, PT at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to evaluate the intra-rater and inter-rater reliability of MyotonPRO in measuring muscle tone and mechanical properties of the wrist extensor and flexor muscles in healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Tone, Viscoelasticity
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Nov 2021to 5 Jan 2022
- Phase
- Observational
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults between 18-35 years old
Who may be able to join
- Age≥18 years
- Body mass index < 30 kg/meter square
- Having no upper extremity injuries
- Willing and able to provide the written informed consent for the study
Who cannot join
- Use of medication that will affect muscle tone
- History of lateral or medial epicondylitis, trauma (elbow, hand or wrist), cervical radiculopathy, peripheral neuropathy or nerve injury (axillary, median, ulnar, radial, musculocutaneous), systemical diseases, muscle disorders (e.g. genetic diseases, neuromuscular disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability of Myotonometer in Evaluating the Muscle Tone and Biomechanical Properties of the Forearm Muscles: Investigation of the Effect of Grip Strength on Mechanical Features
The primary aim of this study was to evaluate the intra-rater and inter-rater reliability of MyotonPRO in measuring muscle tone and mechanical properties of the wrist extensor and flexor muscles in healthy young adults. The secondary aim is to examine whether grip strength has any effect on muscle tone and biomechanical properties.
- Conditions
- Muscular Tone, Viscoelasticity
- Keywords
- elasticity, hardness, forearm muscles
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tone (Hz)
The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the muscle tone of forearm muscles measurements will be performed and recorded.
Measured: Day 1
Stiffness (N/m)
The stiffness which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded.
Measured: Day 1
Elasticity (Logarithmic decrement)
The elasticity which is a viscoelastic property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded.
Measured: Day 1
Secondary outcomes (1)
Grip Strength
Handgrip strength will be measured with the JAMAR Hydraulic Hand Dynamometer. Participants will be asked to sit down with knees and hip flexed to 90⁰, forearm in a neutral position, wrist in 0-30⁰ extension, and 0-5⁰ ulnar deviation while on a chair with backrest. During the measurement, the examiner will instruct them to squeeze the handles of the dynamometer as strongly as possible and then let them loose completely, with a loud motivating command. This will be repeated 3 times with 1-minute rest breaks and the average value will be calculated. During the measurements, the Jamar dynamometer will be grasped from the lower and upper parts by the examiner.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start27 Nov 2021
- Primary completion29 Dec 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular ToneStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- İlke KARA, PT
- Sponsor type
- University, hospital or other
- Collaborators
- Bitlis Eren University, Dokuz Eylul University
- Responsible party
- Sponsor-investigator, İlke KARA, PT, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183659
- Sponsor's protocol ID
- BEU-IK-01
- Status last verified
- Jan 2022
- First submitted
- 2 Dec 2021
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability of Myotonometer in Evaluating the Muscle Tone and Biomechanical Properties of the Forearm Muscles: Investigation of the Effect of Grip Strength on Mechanical Features
- ClinicalTrials.gov ID
- NCT05183659
- Acronym / sponsor ID
- BEU-IK-01
- Conditions
- Muscular Tone, Viscoelasticity
- Keywords
- elasticity, hardness, forearm muscles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- İlke KARA, PTUniversity, hospital or other
- Collaborators
- Bitlis Eren University, Dokuz Eylul University
- Study start
- 27 Nov 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 10 Jan 2022 (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 primary aim of this study was to evaluate the intra-rater and inter-rater reliability of MyotonPRO in measuring muscle tone and mechanical properties of the wrist extensor and flexor muscles in healthy young adults. The secondary aim is to examine whether grip strength has any effect on muscle tone and biomechanical properties.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults between 18-35 years old
Key inclusion criteria (4 listed)
- Age≥18 years
- Body mass index < 30 kg/meter square
- Having no upper extremity injuries
- Willing and able to provide the written informed consent for the study
Key exclusion criteria (2 listed)
- Use of medication that will affect muscle tone
- History of lateral or medial epicondylitis, trauma (elbow, hand or wrist), cervical radiculopathy, peripheral neuropathy or nerve injury (axillary, median, ulnar, radial, musculocutaneous), systemical diseases, muscle disorders (e.g. genetic diseases, neuromuscular disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle tone (Hz)
Time frame: Day 1
The muscle tone which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the muscle tone of forearm muscles measurements will be performed and recorded.
Stiffness (N/m)
Time frame: Day 1
The stiffness which is a biomechanical property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's biomechanical properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded.
Elasticity (Logarithmic decrement)
Time frame: Day 1
The elasticity which is a viscoelastic property of the forearm muscles will be evaluated with a portable hand-held myotonometer. This myotonometer (MyotonPRO - Tallinn, Estonia) is non-invasive and provides a quantitative assessment of a muscle's viscoelastic properties. The MyotonPRO applies a short-intensity mechanical impulse on the skin overlying the muscle or facia. The tissue's response then generates a signal that is recorded, and an internal software program produces an acceleration graph. To determine the feasibility of the MyotonPRO for assessing the stiffness of forearm muscles measurements will be performed and recorded.
1 secondary outcome
Grip Strength
Time frame: Day 1
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 10 Jan 2022.
- Individual participant dataSharing planned: No
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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?
An observational study of Muscular Tone and Viscoelasticity, run by İlke KARA, PT 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 4 inclusion and 2 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 10 Jan 2022. 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?
Muscle tone (Hz) (time frame: Day 1). 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?
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 10 Jan 2022.