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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02852785
Other study ID # FADEUP_PhDPT_NunoMorais_std#3
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 24, 2018
Est. completion date July 2021

Study information

Verified date January 2021
Source Universidade do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main purpose of this study is to characterize and compare the 3D shoulder kinematics bilaterally while performing functional movement patterns tests that hypothetically replicate the 5 main phases of the throwing cycle. The tests are based on diagonal D2 for flexion (early and late cocking of the arm) and D2 for extension (acceleration, deceleration and follow-through of the arm) of the upper extremity of proprioceptive neuromuscular facilitation techniques.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date July 2021
Est. primary completion date April 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PNF D2 for flexion; low-to-moderate loading condition
Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition
PNF D2 for flexion; moderate-to-high loading condition
Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition
PNF D2 for extension; low-to-moderate loading condition
Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition
PNF D2 for extension; moderate-to-high loading condition
Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition

Locations

Country Name City State
Portugal Escola Superior de Saúde, Instituto Politécnico de Leiria Leiria
Portugal Faculdade de Motricidade Humana, Universidade de Lisboa Oeiras Cruz-Quebrada
Portugal Faculdade de Desporto, Universidade do Porto Porto

Sponsors (3)

Lead Sponsor Collaborator
Universidade do Porto Instituto Politécnico de Leiria, University of Lisbon

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Side-to-side differences in 3-dimensional scapular angular displacement (in degrees) 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) Through study completion, an average of 1 year
Primary Side-to-side differences in 3-dimensional humerus angular displacement (in degrees) 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) Through study completion, an average of 1 year
Primary Side-to-side differences in 3-dimensional thoracic angular displacement (in degrees) 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) Through study completion, an average of 1 year
Secondary Borg's Rate of Perceived Exertion scale Rate of Perceived Exertion (RPE) scale varies from 6 (no exertion) to 20 (very, very hard) Through study completion, an average of 1 year
Secondary Visual Numeric Rating Scale score (0-10) A 11-point scale to rate pain intensity Through study completion, an average of 1 year
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