- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04697108
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
48
Phase
- 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
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brazil, 19.060-900
- 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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
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 5, 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 5, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Other Study ID 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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