NCT02852707

Brief Summary

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

July 22, 2016

Last Update Submit

January 5, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Side-to-side differences in the unilateral seated shot put test (normalized distance thrown, in centimeters)

    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)

    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 Outcomes (5)

  • Side-to-side differences in 3-dimensional scapular angular displacement (in degrees)

    Through study completion, an average of 1 year

  • Side-to-side differences in 3-dimensional humerus angular displacement (in degrees)

    Through study completion, an average of 1 year

  • Side-to-side differences in 3-dimensional thoracic angular displacement (in degrees)

    Through study completion, an average of 1 year

  • Side-to-side differences in the upper quarter Y balance test (total excursion, 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)

    Through study completion, an average of 1 year

Study Arms (3)

Unilateral overhead throwing athletes

Volleyball attackers involved in competitive events ≥ 2 years, ≥18 years of age

Behavioral: Chronic exposure to unilateral overhead sports activity

Bilateral overhead athletes

Swimmers involved in competitive events ≥ 2 years, ≥18 years of age

Behavioral: Chronic exposure to bilateral overhead sports activity

Non-athletes

Persons not regularly involved in sports activities or occupational overhead tasks (e.g. construction workers), ≥18 years of age

Behavioral: Not exposed

Interventions

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).

Unilateral overhead throwing athletes

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").

Bilateral overhead athletes
Not exposedBEHAVIORAL

People not engaged in regular sports competition/exercise training.

Non-athletes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Perform at least 150 degrees of arm elevation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Faculdade de Motricidade Humana, Universidade de Lisboa

Oeiras, Cruz-Quebrada, 1499-002, Portugal

Location

Escola Superior de Saúde, Instituto Politécnico de Leiria

Leiria, 2411-901, Portugal

Location

Faculdade de Desporto, Universidade do Porto

Porto, 4200-450, Portugal

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 2, 2016

Study Start

June 1, 2018

Primary Completion

April 1, 2021

Study Completion

July 1, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations