Physical Performance and 3D Shoulder Kinematics of Asymptomatic Unilateral/Bilateral Overhead Athletes and Non-athletes

January 5, 2021 updated by: Nuno Morais, Universidade do Porto
This study compares the performance and 3-dimensional shoulder kinematics between sides in unilateral overhead-throwers (volleyball attackers), bilateral overhead athletes (swimmers) and non-athletes during two physical performance measures of the upper extremity, one in an open kinetic chain position (unilateral seated shot put test) and the other in a closed kinetic chain position (upper quarter Y balance test)

Study Overview

Status

Status

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

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

3-dimensional shoulder kinematics (e.g., scapular angular position/displacement) at key events of each test will be described and compared across sides and groups. For the unilateral seated shot put test, the events are based on humeral motion: a) initiation of humeral motion, b) maximal humeral flexion, c) end of humeral motion. For the upper quarter Y balance test the events are the a) initiation of free hand motion on "GO", b) maximal reach on the medial direction, c) maximal reach on superolateral direction, and d) maximal reach on the inferolateral direction (kinematics measured on the stance upper extremity). The best of 3 maximal-effort trials on each side will be used for analysis. Warm-up exercises and two submaximal practice trials will be performed for preparation for maximal efforts and familiarization with the tests. A rest period of at least one minute between trials will be given to guarantee good physiological conditions to maximally perform. Further resting time will be allowed, if necessary, upon request of the participant.

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.
Observational

Enrollment (Anticipated)

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.
90

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

  • Portugal
      • Leiria, Portugal, 2411-901
        • Escola Superior de Saúde, Instituto Politécnico de Leiria
      • Porto, Portugal, 4200-450
        • Faculdade de Desporto, Universidade do Porto
    • Cruz-Quebrada
      • Oeiras, Cruz-Quebrada, Portugal, 1499-002
        • Faculdade de Motricidade Humana, Universidade de Lisboa

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Athletes from sports organizations involved in competitive events and non-athletes from the general community/scholarly community

Description

Inclusion Criteria:

  • Perform at least 150 degrees of arm elevation

Exclusion Criteria:

  • history of shoulder dislocation
  • surgery in the upper extremity ≥ 6 months
  • injury in the past month
  • evident abnormalities in posture and movement of the upper body quadrant
  • pain at the time of testing

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Unilateral overhead throwing athletes
Volleyball attackers involved in competitive events ≥ 2 years, ≥18 years of age
Behavioral: Chronic exposure to unilateral overhead sports activity
Overhead sports athletes that have been chronically exposed (≥ 2 years) predominantly to specific unilateral overhead movement patterns of the dominant extremity ("throwing arm"), such as throwing or hitting a ball ("asymmetrical overhead sports).
Bilateral overhead athletes
Swimmers involved in competitive events ≥ 2 years, ≥18 years of age
Behavioral: Chronic exposure to bilateral overhead sports activity
Overhead sports athletes that have been chronically exposed (≥ 2 years) predominantly to bilateral overhead movement patterns of the upper extremities, such as swimmers ("symmetrical overhead sports").
Non-athletes
Persons not regularly involved in sports activities or occupational overhead tasks (e.g. construction workers), ≥18 years of age
Behavioral: Not exposed
People not engaged in regular sports competition/exercise training.

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
Side-to-side differences in the unilateral seated shot put test (normalized distance thrown, in centimeters)
Time Frame: Through study completion, an average of 1 year
The unilateral seated shot put test consists of pushing (not throwing) at shoulder height a ~3kg medicine ball as far and forward as possible while keeping the axial skeleton in contact with a wall, knees bent at a right angle, feet flat on the floor, and the non-testing arm resting on the lap.
Through study completion, an average of 1 year
Side-to-side differences in the upper quarter Y balance test (normalized maximal distance reached in each direction, in centimeters)
Time Frame: Through study completion, an average of 1 year
The upper quarter Y balance test is performed through the assistance of a testing device (Y-Balance Test Kit), with the subject stabilizing his/her body weight with the upper extremity being tested while performing maximal reaching efforts with the free hand in three directions: medial, superolateral, and inferolateral.
Through study completion, an average of 1 year

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
Side-to-side differences in 3-dimensional scapular angular displacement (in degrees)
Time Frame: Through study completion, an average of 1 year
The angular displacement of the scapula in the 3 planes of orientation: lateral/medial (upward/downward) rotation, protraction/retraction (internal/external rotation), anterior/posterior tilting.
Through study completion, an average of 1 year
Side-to-side differences in 3-dimensional humerus angular displacement (in degrees)
Time Frame: Through study completion, an average of 1 year
The angular displacement of the humerus in the 3 planes of orientation: plane of elevation, elevation/depression, axial rotation.
Through study completion, an average of 1 year
Side-to-side differences in 3-dimensional thoracic angular displacement (in degrees)
Time Frame: Through study completion, an average of 1 year
The angular displacement of the thorax in the 3 planes of orientation: flexion/extension, lateral rotation (inclination), axial rotation.
Through study completion, an average of 1 year
Side-to-side differences in the upper quarter Y balance test (total excursion, in centimeters)
Time Frame: Through study completion, an average of 1 year
total excursion = sum of the 3 normalized reach distances, in centimeters
Through study completion, an average of 1 year
Side-to-side differences in the upper quarter Y balance test (overall performance score, in centimeters)
Time Frame: Through study completion, an average of 1 year
overall performance or composite score = average score of the 3 normalized reach distances, in centimeters.
Through study completion, an average of 1 year

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.
Universidade do Porto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Lisbon
Instituto Politécnico de Leiria

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.
June 1, 2018

Primary Completion (ANTICIPATED)

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.
April 1, 2021

Study Completion (ANTICIPATED)

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.
July 1, 2021

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).
July 22, 2016

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.
July 28, 2016

First Posted (ESTIMATE)

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.
August 2, 2016

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

Additional Relevant MeSH Terms

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.
  • FADEUP_PhDPT_NunoMorais_std#1

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