Muscular ToneNCT06004635
Reliability of Myotonometry in the Assessment of Mechanical Properties of Thenar Muscles
An observational study of Muscular Tone, run by Ilke KARA at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties. 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
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 May 2024
- 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
- being between 18 and 35 years of age
- having normal upper extremity function
- having a Montreal Cognitive Assessment Test (MoCA) score > 26 points
Who cannot join
- any neuromuscular or musculoskeletal disease
- history of upper limb injury
- upper limb surgery within the last 6 months
- body mass index (BMI) > 30 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability and Sex-Based Variations in Myotonometer Assessment of Thenar Muscle Properties: Implications for Grip Strength
This study aimed to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties.
Read the detailed description
Investigating the mechanical properties of hand muscles using simple applicable methods such as myotonometer can help to evaluate the effectiveness of programs used in hand rehabilitation, optimize the skills of performance-oriented individuals such as athletes and musicians, and create individualized treatment and training programs. In musculoskeletal-related pathologies such as carpal tunnel syndrome, studying the mechanical properties of the thenar muscles may be important to better understand hand grip strength, hand function and mobility. However, the use of myotonometer in the evaluation of the mechanical properties of the thenar muscles requires a reliability study. Accordingly, the aims of our study are: to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties.
- Conditions
- Muscular Tone
- Keywords
- rehabilitation, biomechanics, assessment, skeletal muscle
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: 30 Minutes
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: 30 Minutes
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: 30 Minutes
Secondary outcomes (1)
Pinch strength
Pinch grip strength will be assessed using a hydraulic pinchmeter (Baseline). Standard procedures recommended by American Society of Hand Therapists (ASHT) will be followed.
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Sep 2023
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ilke KARA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ilke KARA, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004635
- Sponsor's protocol ID
- BEU-KTS-02
- Status last verified
- May 2024
- First submitted
- 24 Jul 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saldiran TC, Schleip R, Tanhan A, Ozturk O, Kara I. Quantifying thenar muscle biomechanical properties: Sex-based variations and implications for grip strength. J Hand Ther. 2025 Jul-Sep;38(3):594-604. doi: 10.1016/j.jht.2024.11.009. Epub 2025 Jan 6.
PubMed 39765426
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Sex-Based Variations in Myotonometer Assessment of Thenar Muscle Properties: Implications for Grip Strength
- ClinicalTrials.gov ID
- NCT06004635
- Acronym / sponsor ID
- BEU-KTS-02
- Conditions
- Muscular Tone
- Keywords
- rehabilitation, biomechanics, assessment, skeletal muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ilke KARAUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 22 Aug 2023 (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 aimed to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical properties.
Detailed description
Investigating the mechanical properties of hand muscles using simple applicable methods such as myotonometer can help to evaluate the effectiveness of programs used in hand rehabilitation, optimize the skills of performance-oriented individuals such as athletes and musicians, and create individualized treatment and training programs. In musculoskeletal-related pathologies such as carpal tunnel syndrome, studying the mechanical properties of the thenar muscles may be important to better understand hand grip strength, hand function and mobility. However, the use of myotonometer in the evaluation of the mechanical properties of the thenar muscles requires a reliability study. Accordingly, the aims of our study are: to (i) assess the reliability of myotonometer measurements in determining the mechanical properties of thenar muscle in healthy individuals and explore gender-based variations in these properties; (ii) examine the relationship between pinch grip strength and these mechanical 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 (3 listed)
- being between 18 and 35 years of age
- having normal upper extremity function
- having a Montreal Cognitive Assessment Test (MoCA) score > 26 points
Key exclusion criteria (4 listed)
- any neuromuscular or musculoskeletal disease
- history of upper limb injury
- upper limb surgery within the last 6 months
- body mass index (BMI) > 30 kg/m2.
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: 30 Minutes
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: 30 Minutes
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: 30 Minutes
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
Pinch strength
Time frame: 30 Minutes
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 3 May 2024.
- Derived from this study: PubMed 39765426Saldiran TC, Schleip R, Tanhan A, Ozturk O, Kara I. Quantifying thenar muscle biomechanical properties: Sex-based variations and implications for grip strength. J Hand Ther. 2025 Jul-Sep;38(3):594-604. doi: 10.1016/j.jht.2024.11.009. Epub 2025 Jan 6.
- Individual participant dataSharing planned: No
Related trials for Muscular Tone
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Not yet recruiting
Local Vibration and Ankle Mobilization in Multiple Sclerosis
Multiple Sclerosis
Recruiting
Task-Oriented Upper Limb Training With Focal Vibration in Stroke
Stroke
Not yet recruiting
Inductive Therapeutic Exercise in Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Outcomes of Neurosurgical Tone Management
Spastic/Dystonic Quadriplegia, Cerebral Palsy (CP)
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, run by Ilke KARA 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 3 inclusion and 4 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 3 May 2024. 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: 30 Minutes). 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 NCT06004635, which also lists 1 linked publication.
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 3 May 2024.