NCT02852746

Brief Summary

The study aims to compare the performance and the 3D shoulder kinematics of volleyball attackers with and without scapular dyskinesis and shoulder symptoms in two physical performance measures of the upper extremity, and correlate their outcomes with a self-reported measure of function of the upper extremity.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 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 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
2 years until next milestone

Study Start

First participant enrolled

July 24, 2018

Completed
2.7 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

2.7 years

First QC Date

July 25, 2016

Last Update Submit

January 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • Disabilities of the Arm, Shoulder and Hand (sports module)

    A self-reported measure of upper extremity functioning

    Through study completion, an average of 1 year

Secondary Outcomes (6)

  • 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

  • Visual Numeric Rating Scale score (0-10)

    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

  • +1 more secondary outcomes

Study Arms (2)

Asympt. athletes / scapular dyskinesis

Asymptomatic volleyball attackers involved in competitive events ≥ 2 years and with clinical evidence of scapula dyskinesis

Behavioral: Performance measures of the upper extremity

Symptom. athletes / scapular dyskinesis

Symptomatic volleyball attackers involved in competitive events ≥ 2 years and with clinical evidence of scapula dyskinesis

Behavioral: Performance measures of the upper extremity

Interventions

Athletes will perform the unilateral seated shot put test (USSPT) and the upper quarter Y balance test (UQYBT) bilaterally.

Asympt. athletes / scapular dyskinesisSymptom. athletes / scapular dyskinesis

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Athletes from sports organizations involved in competitive events with pain and disability in the shoulder region

You may qualify if:

  • subjects who can perform at least 150 degrees of arm elevation

You may not qualify if:

  • subjects rating pain ≥8/10
  • score 5 on any of the items of the DASH
  • pain elicited by provocation maneuvers of the neighboring regions (e.g., cervical spine).

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 25, 2016

First Posted

August 2, 2016

Study Start

July 24, 2018

Primary Completion

April 1, 2021

Study Completion

July 1, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations