Reliability of a Proprioception Test in Swimmers

January 5, 2021 updated by: São Paulo State University

Reliability of a Proprioception Teste in Swimmers Athletes

To evaluate the intra- and inter-rater reliability of a test of active shoulder proprioception with a laser pointer in swimming athletes and to describe the profile of the proprioception measures characterizing the sample according to the specialty within the sport and the category of the athletes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction: Obtaining the reliability of an evaluative instrument is of paramount importance for its applicability in the field of clinical physiotherapy and in the sports field, providing consistent and real measures. Shoulder proprioception assessments have started to appear on the scientific scene in recent years and several tools, methods and protocols are being studied. However, the lack of standardization of protocols and application in different populations produces inconsistencies in the findings, thus hindering the use of these models. Thus, standardizing the application of the test and investigating a population different from what appears in the scientific scenario in relation to sports, such as swimming athletes, seems to be relevant and would contribute to the use of scientific evaluative models in the clinical environment. Objectives: To evaluate the intra- and inter-rater reliability of a test of active shoulder proprioception with a laser pointer in swimming athletes and to describe the profile of the proprioception measures characterizing the sample according to the specialty within the sport and the category of the athletes. Methods: Study of intra- and inter-rater reliability of the shoulder proprioception test with a laser pointer, composed of 48 young male and female swimming athletes, aged between 12 and 20 years. It will be carried out in three stages: (1) Familiarization, (2) Test and (3) Retest, all stages will take place on the same day, and stages 2 and 3 will be performed by two different evaluators. To characterize the sample, descriptive statistics will be used by means of central tendency and variability, for all variables collected. Relative reliability will be tested by the Intraclass Correlation Coefficient (ICC), with a 95% confidence interval. The ICC will be interpreted as values <0.5 indicate low reliability, between 0.5 and 0.75, moderate reliability, between 0.75 and 0.9, good reliability and values> 0.90 excellent reliability. And the absolute reliability will be verified by means of the standard error of the measurement (EPM), by values of minimum detectable change (MMD), and the coefficient of variation (CV).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Brazil
    • São Paulo
      • Presidente Prudente, São Paulo, Brazil, 19.060-900
        • University of Sao Paulo State

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female swimming athletes;
  • Between 12 and 26 years old;
  • Train regularly and be members of swimming teams in the 4th Region of the State of São Paulo, and athletes from the São Paulo Aquatic Federation (FAP),
  • Reporting the absence of anemia, inflammatory process, diabetes, cardiovascular disease, episodes of muscle - tendon or osteoarticular injury in the lower, upper and / or spine members in the last three months.

Exclusion Criteria:

  • Practice of sports for less than 1 year.
  • Use anti-inflammatory and / or analgesic drugs for less than 24 hours before the test.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Proprioception Test (TRMOPL)
In the Familiarization stage (1), the TRMOPL was applied by means of a single evaluator with the aim of knowledge and understanding of the test. After five minutes, step (2) test started. In this step, the test was applied twice, by different evaluators, with an interval of five minutes between applications (inter-rater reliability). Ten minutes after the end of the tests, step (3) retest (intra-rater reliability) was started, following the same procedures as in step 2. The order of the evaluators was randomized through a draw in Excel, the order of randomization of the steps (2) and (3) was the same in order not to influence intra-rater reliability.
Other: Shoulder reproduction teste assisted by laser pointer
In the step (1) of Familiarization in which the SRTLP was applied through a single evaluator with the aim of knowledge and understanding of the test. After five minutes, step (2) test started. In this step, the test was applied twice, by different evaluators, with an interval of five minutes between applications (inter-rater reliability). Ten minutes after the end of the tests, step (3) retest (intra-rater reliability) was started, following the same procedures as in step 2. The order of the evaluators was randomized through a draw in Excel, the order of randomization of the steps (2) and (3) was the same in order not to influence intra-rater reliability

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Joint Position Sense
Time Frame: One hour
the movement reproduction test was applied by a laser pointer and the measurements presented were angular deviation in degrees.
One hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Shoulder Pain
Time Frame: 5 minutes
Pain measurements were performed using a visual pain scale
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
São Paulo State University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FIS190111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual data will not be released, because particpants 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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