Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reliability of Myotonometry in Swimming Athletes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04697433
Recruitment Status : Completed
First Posted : January 6, 2021
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
São Paulo State University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment
Athletes Device: Myotonometry

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Reliability of Myotonometry in Swimming Athletes
Actual Study Start Date : February 3, 2020
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : March 16, 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
 Device: Myotonometry
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Muscle Tone [ Time Frame: 75 minutes ]
    MyotonPro (MyotonAS, Tallinn, Estonia), measured in Hertz (Hz)

  2. Stiffness [ Time Frame: 75 minutes ]
    MyotonPro (MyotonAS, Tallinn, Estônia), measured in Newton / meter (N/m)


Secondary Outcome Measures :
  1. Elasticity [ Time Frame: 75 minutes ]
    MyotonPro (MyotonAS, Tallinn, Estonia)

  2. Mechanical Stress Relaxation Time [ Time Frame: 75 minutes ]
    MyotonPro (MyotonAS, Tallinn, Estonia), measured in milliseconds (ms)

  3. Creep [ Time Frame: 75 minutes ]
    MyotonPro (MyotonAS, Tallinn, Estonia)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697433


Locations
Layout table for location information
Brazil
University of Sao Paulo State
Presidente Prudente, São Paulo, Brazil, 19060-900
Sponsors and Collaborators
São Paulo State University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: São Paulo State University
ClinicalTrials.gov Identifier: NCT04697433    
Other Study ID Numbers: FIS190047
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data will not be disclosed, because as participants are under eighteen

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No