- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05183659
The Reliability of Myotonometer in Evaluating the Muscle Tone and Biomechanical Properties of the Forearm Muscles
January 5, 2022 updated by: İlke KARA, PT
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
56
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
-
-
-
Bitlis, Turkey, 13000
- Bitlis Eren University
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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 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy adults between 18-35 years old
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Day 1
|
|
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.
|
Day 1
|
|
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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grip Strength
Time Frame: Day 1
|
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.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 27, 2021
Primary Completion (Actual)
December 29, 2021
Study Completion (Actual)
January 5, 2022
Study Registration Dates
First Submitted
December 2, 2021
First Submitted That Met QC Criteria
January 5, 2022
First Posted (Actual)
January 10, 2022
Study Record Updates
Last Update Posted (Actual)
January 10, 2022
Last Update Submitted That Met QC Criteria
January 5, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BEU-IK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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