AthletesNCT04697108
Reliability of a Proprioception Test in Swimmers
A study testing Shoulder reproduction teste assisted by laser pointer in people with Athletes, run by São Paulo State University at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- Shoulder reproduction teste assisted by laser pointer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Feb 2020to 16 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Practice of sports for less than 1 year.
- Use anti-inflammatory and / or analgesic drugs for less than 24 hours before the test.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo State
Presidente Prudente, São Paulo, 19.060-900
About this study
Official title: 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.
Read the 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).
- Conditions
- Athletes
- Being tested
- Shoulder reproduction teste assisted by laser pointer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder reproduction teste assisted by laser pointerOther
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
| Study group | Role | What they receive |
|---|---|---|
| Proprioception Test (TRMOPL) | Other | 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. Receives: Other: Shoulder reproduction teste assisted by laser pointer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Position Sense
the movement reproduction test was applied by a laser pointer and the measurements presented were angular deviation in degrees.
Measured: One hour
Secondary outcomes (1)
Shoulder Pain
Pain measurements were performed using a visual pain scale
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start3 Feb 2020
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697108
- Sponsor's protocol ID
- FIS190111
- Status last verified
- Jan 2021
- First submitted
- 4 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be released, because particpants are under eighteen.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of a Proprioception Teste in Swimmers Athletes
- ClinicalTrials.gov ID
- NCT04697108
- Acronym / sponsor ID
- FIS190111
- Conditions
- Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proprioception Test (TRMOPL) | Other | Other: Shoulder reproduction teste assisted by laser pointerIn 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. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Practice of sports for less than 1 year.
- Use anti-inflammatory and / or analgesic drugs for less than 24 hours before the test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder reproduction teste assisted by laser pointerIn 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 | Other | Proprioception Test (TRMOPL) |
Primary outcome
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.
1 secondary outcome
Shoulder Pain
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No. Individual data will not be released, because particpants are under eighteen.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder reproduction teste assisted by laser pointer in people with Athletes, run by São Paulo State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Position Sense (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.