- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02852785
3D Shoulder Kinematics During Throwing-related Movement Patterns Tasks in Upper Extremity Low-to-moderate/Moderate-to-high Loading Conditions
Study Overview
Status
Conditions
Detailed Description
The 3D shoulder kinematics (thorax, scapula and humerus) will be collected in different groups of subjects with specific characteristics. To load the upper extremity during PNF D2 for flexion and extension directions, elastic tubing (Thera-Band) will be used as resistance. Selection of the two resistances will be according to a self-perceived ability of the subjects to consistently move a maximal amount of resistance (color) during PNF D2 flexion and extension tests for 15s and 30s, respectively. Each subject will be permitted to sample various resistances in order to assist in selecting the most appropriate load, with no more than three practice repetitions permitted per each resistance sampled.
To perform the tests, subjects will be sited in a standard chair without armrests, with their feet and lower legs placed on another standard chair, positioned just in front of their chair and the non-testing arm placed across the thoracic wall, to minimize the participation of the legs and trunk to upper extremity performance during testing. Elastic tubing will be anchored to a stable base to perform the diagonals (Thera-Band door anchor accessory or the opposite foot). Five repetitions of each test on both sides will be performed, in two different moments (5-10 minutes apart). A rate of 2 seconds per repetition will be employed during recordings using a metronome. A rest period will be given between trials to avoid fatigue. To perform the tests, subjects will begin/end with their hand on the contralateral hip and end/begin at head height and shoulder width. A marker will be placed in the latter position to standardize the start and end of hand position. The order of the tests (PNF D2 flexion and extension) and side (symptomatic/dominant and asymptomatic/non-dominant) will be randomized.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Leiria, Portugal, 2411-901
- Escola Superior de Saúde, Instituto Politécnico de Leiria
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Porto, Portugal, 4200-450
- Faculdade de Desporto, Universidade do Porto
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Cruz-Quebrada
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Oeiras, Cruz-Quebrada, Portugal, 1499-002
- Faculdade de Motricidade Humana, Universidade de Lisboa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- subjects who can perform at least 150 degrees of arm elevation
Exclusion Criteria:
- subjects rating pain ≥8/10
- score 5 on any of the items of the Disabilities of Arm, Shoulder and Hand (DASH)
- pain elicited by provocation maneuvers of the neighboring regions (e.g., cervical spine).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Asymptomatic volleyball attackers
Asymptomatic volleyball attackers involved in competitive events ≥ 2 years and no signs of postural and movement impairments of the upper body quadrant
|
Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition
Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition
|
|
Asymptomatic bilateral overhead athletes
Asymptomatic swimmers involved in competitive events ≥ 2 years and no signs of postural and movement impairments of the upper body quadrant
|
Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition
Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition
|
|
Asymptomatic non-athletes
Asymptomatic persons not regularly involved in sports activities or occupational overhead tasks (e.g.
construction workers),
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Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition
Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition
|
|
Asympt. athletes / scapula dyskinesis
Asymptomatic volleyball attackers involved in competitive events ≥ 2 years and with clinical evidence of scapula dyskinesis
|
Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition
Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition
|
|
Symptom. athletes / scapula dyskinesis
Volleyball attackers involved in competitive events ≥ 2 years and with clinical evidence of scapula dyskinesis and complaints of shoulder pain and disability
|
Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition
Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition
Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Side-to-side differences in 3-dimensional scapular angular displacement (in degrees)
Time Frame: Through study completion, an average of 1 year
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The angular position and displacement of the scapula in the 3 planes of [lateral/medial (upward/downward) rotation, protraction/retraction (internal/external rotation), anterior/posterior tilting] at 4 key events of the simulated throwing motion during the two loading conditions (1, initiation of humeral motion; 2, maximum humeral horizontal abduction relative to the trunk; 3, maximum humeral external rotation; 4, maximum humeral internal rotation)
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Through study completion, an average of 1 year
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Side-to-side differences in 3-dimensional humerus angular displacement (in degrees)
Time Frame: Through study completion, an average of 1 year
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The angular position and displacement of the humerus in the 3 planes of (plane of elevation, elevation/depression, axial rotation) at 4 key events of the simulated throwing motion during the two loading conditions (1, initiation of humeral motion; 2, maximum humeral horizontal abduction relative to the trunk; 3, maximum humeral external rotation; 4, maximum humeral internal rotation)
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Through study completion, an average of 1 year
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Side-to-side differences in 3-dimensional thoracic angular displacement (in degrees)
Time Frame: Through study completion, an average of 1 year
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The angular position and displacement of the thorax in the 3 planes of [flexion/extension, lateral rotation (inclination), axial rotation] at 4 key events of the simulated throwing motion during the two loading conditions (1, initiation of humeral motion; 2, maximum humeral horizontal abduction relative to the trunk; 3, maximum humeral external rotation; 4, maximum humeral internal rotation)
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Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Numeric Rating Scale score (0-10)
Time Frame: Through study completion, an average of 1 year
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A 11-point scale to rate pain intensity
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Through study completion, an average of 1 year
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Borg's Rate of Perceived Exertion scale
Time Frame: Through study completion, an average of 1 year
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Rate of Perceived Exertion (RPE) scale varies from 6 (no exertion) to 20 (very, very hard)
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Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FADEUP_PhDPT_NunoMorais_std#3
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