Motions of the Bones and Activation of the Muscles of the Shoulder Girdle During Basic and Common Arm Movement
NCT ID: NCT04571268
Last Updated: 2021-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
45 participants
OBSERVATIONAL
2019-01-28
2022-12-30
Brief Summary
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Upon completion of this study a comprehensive database of three-dimensional joint angles and EMG patterns of the structures of the shoulder joint complex of dominant and non-dominant during common activities of daily living will be available for healthy subjects and those of subjects whose dominant limbs are impaired by rotator cuff tears. These data will show normal muscle activations and movement patterns required to complete activities of daily living and compare them to the movement, and muscle activation patterns of persons who exhibit muscular and movement dysfunction due to rotator cuff tears.
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Detailed Description
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These data will enable medical professionals to better answer a range of clinical questions. They will provide health care professionals and researchers with a knowledge of relative muscle contributions to specific joint motions required to perform activities of daily living. This information is well suited to refine input variables for computer models and robotic testing platforms which can improve virtual and cadaver testing of shoulder impairment and repair models. Understanding the limitations to movement caused by RCT, and the resulting muscle activation patterns, will inform better surgical indications and enable therapists to better design rehabilitation protocols to enhance recovery from rotator cuff tears with or without surgery, as well as develop programs to limit future tears. Knowledge of muscle activation patterns during activities of daily living will also allow pre-habilitation protocols to be tailored for a subsequent surgical procedure such as reverse shoulder arthroplasty. These data will also assist in the design of shoulder prostheses whose biomechanical characteristics will compensate for deficiencies present in a shoulder joint impaired by rotator cuff injury. The knowledge gained from this study will provide a basis for future studies investigating traumatic shoulder injuries and the design of effective rehabilitation protocols for such injuries.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Healthy validation subjects
Healthy subjects who meet the inclusion criteria and participate in data collection for the purpose of developing and validating the biomechanical models used to track scapular motion
No interventions assigned to this group
Healthy comparison subjects
Healthy subjects who meet the inclusion criteria and participate in data collection for comparison of shoulder motion and muscle activation patterns with RCT subjects
No interventions assigned to this group
RCT subjects
Subjects who have sustained a major rotator cuff tear
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Right hand dominant
* English speaking
* Subjects who have read and signed IRB approved informed consent for the study.
RCT subjects:
* Chronic right-side side shoulder pain with documented rotator cuff tear involving 2 or more tendons, and greater than 5cm as diagnosed by MRI
* Exhibit right rotator cuff disfunction without corresponding changes in the glenohumeral joint.
* Weakness of right rotator cuff isolated function based on clinical exam findings.
* Fatty infiltration grade 2 or more for involved muscle bellies based on MRI findings.
Exclusion Criteria
* Diagnosis of osteoarthritis of the shoulder on their right side.
* History of musculoskeletal injury or disorder affecting any part of the right arm except the rotator cuff of the shoulder.
* History of musculoskeletal injury or disorder affecting any part of the left arm.
* Any musculoskeletal injury or disorder which prevents the subject standing unassisted for an extended period.
* Parkinson's disease.
* History of cerebral vascular accident.
* Pregnant.
* Current Incarceration.
50 Years
70 Years
ALL
Yes
Sponsors
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DePuy Synthes Products, Inc.
INDUSTRY
More Foundation
OTHER
Responsible Party
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Principal Investigators
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Marc D Jacofsky, PhD
Role: STUDY_DIRECTOR
More Foundation
Locations
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MORE Foundation
Phoenix, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4030
Identifier Type: -
Identifier Source: org_study_id
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