- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697433
Reliability of Myotonometry in Swimming Athletes
January 4, 2021 updated by: São Paulo State University
The clinical analysis of athletes has been performed in the sports field to obtain parameters for reliable evaluations.
Among the tools used is the myotonometry, an analysis capable of quantitatively measuring tone, stiffness and elasticity.
Its reliability has been tested in several populations, however, showing changes in results and presenting high variability in the confidence interval, also, the values of myotonometry differ according to sample specificity and the biomechanical properties of each muscle.
Therefore, it seems pertinent to perform the reliability analysis in swimming athletes and verify their applicability and if the values of tone and muscular biomechanical properties vary according to the specificity of the modality.
It will be a test and retest study composed of 50 young male and female swimming athletes, aged between 12 and 20 years.
The evaluation of myotonometry will be performed randomly by two evaluators and the parameters measured will be: tone, stiffness, elasticity, relaxation time of mechanical stress and displacement.
In the test stage, the first evaluator will perform the measurements bilaterally on the muscles and the second evaluator will perform the same measurements in the same order immediately after the first one.
After 15 minutes, the retest will be performed following the same order of evaluators in the test.
For characterization of sample will be used descriptive statistic through central tendency and variability for all variables collected.
Relative reliability will be tested by the Intraclass Correlation Coefficient (ICC).
Absolute reliability will be verified by means of standard error of measurement (SEM), values of least detectable change (MMD) and coefficient of variation (CV).
The statistical package SPSS Statistics 22.0 will be used to conduct the reliability analyses.
Study Overview
Study Type
Observational
Enrollment (Actual)
48
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
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São Paulo
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Presidente Prudente, São Paulo, Brazil, 19060-900
- University of Sao Paulo State
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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
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Young swimming athletes who regularly train and are members of the swimming teams of the 4th region of the state of São Paulo, of the São Paulo Aquatic Federation (FAP), of the cities of Presidente Prudente, Votuporanga and São José do Rio Preto.
Description
Inclusion Criteria:
- Healthy swimming athletes
Exclusion Criteria:
- Being an alcoholic, consuming drugs, smoking or anti-inflammatory and / or analgesic drugs less than 24 hours before the test, presenting anemia, inflammatory process, diabetes, cardiovascular disease, episodes of muscle-tendon or osteoarticular injury in the lower, upper and / or lower limbs spine in the last three months, in addition to swimming for less than two years.
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
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Myotonometry
The evaluation of myotonometry will be carried out by two independent evaluators.
The first evaluator will perform the test bilaterally on the middle deltoid, upper trapezius, pectoralis major, biceps brachii, rectus femoris, anterior tibialis, triceps brachii, lumbar multifidus, biceps femoris and soleus previously marked.
Immediately after, the second appraiser will perform the same measurements in the same order (Inter-rater reliability).
After a 15-minute interval, the retest (intra-rater reliability) will be performed following the same procedure and order as the test step.
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The examiner should exert a slight pressure on the determined point to the necessary depth, which will be indicated by changing the color from red to green light on the device.
The device has an automatically controlled preload (0.18 Newton (N)) that will be applied to the contact area by an automatic mechanical pulse, with a duration of 15 milliseconds (ms) and a constant force of 0.4 N , these oscillations will be registered by an accelerometer next to the measurement mechanism inside the device.
For each evaluation, a series of 10 consecutive pulses (multiscan mode) will be used with an interval of one second between each pulse.
In each shot, the tone, stiffness, elasticity, relaxation time and creep will be calculated.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Tone
Time Frame: 75 minutes
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MyotonPro (MyotonAS, Tallinn, Estonia), measured in Hertz (Hz)
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75 minutes
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Stiffness
Time Frame: 75 minutes
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MyotonPro (MyotonAS, Tallinn, Estônia), measured in Newton / meter (N/m)
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75 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elasticity
Time Frame: 75 minutes
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MyotonPro (MyotonAS, Tallinn, Estonia)
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75 minutes
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Mechanical Stress Relaxation Time
Time Frame: 75 minutes
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MyotonPro (MyotonAS, Tallinn, Estonia), measured in milliseconds (ms)
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75 minutes
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Creep
Time Frame: 75 minutes
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MyotonPro (MyotonAS, Tallinn, Estonia)
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75 minutes
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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)
February 3, 2020
Primary Completion (Actual)
March 16, 2020
Study Completion (Actual)
March 16, 2020
Study Registration Dates
First Submitted
January 4, 2021
First Submitted That Met QC Criteria
January 4, 2021
First Posted (Actual)
January 6, 2021
Study Record Updates
Last Update Posted (Actual)
January 6, 2021
Last Update Submitted That Met QC Criteria
January 4, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- FIS190047
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Individual data will not be disclosed, because as participants are under eighteen
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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