Motions of the Bones and Activation of the Muscles of the Shoulder Girdle During Basic and Common Arm Movement

NCT04571268 | Unknown

• 1 other identifier: 4030
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

A comprehensive understanding of healthy shoulder motion is a valuable contribution to the academic literature and provides a basis of comparison for various shoulder pathologies and treatments. However, the medical community is primarily interested in how pathology affects shoulder function and the underlying musculoskeletal reasons for impaired function associated with specific pathologies. Rotator cuff tears (RCT) provide an excellent model to study shoulder biomechanics because RCTs can cause significant functional impairment and can be quantified in size and location using standard clinical imaging techniques. 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.

Conditions

Rotator Cuff Tears

Keywords

Rotator cuff tear; Shoulder motion; Shoulder muscle activation

Outcome Measures

Primary Outcomes (2)

• Range of motion

  Measure range of motion in abduction, forward flexion, external rotation in neutral position and external rotation at 90 degrees abductions with corresponding rotator cuff muscle activation patterns

  At enrollment

• Activities of Daily Living

  Measure glenohumeral joint angles and rotator cuff muscle activation patterns during the performance of prescribed activities of daily living

  At enrollment

Secondary Outcomes (1)

• Patient reported outcome

  At enrollment

Study Arms (3)

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

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

RCT subjects

Subjects who have sustained a major rotator cuff tear

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 50 and 70 years old, inclusive, who present with chronic right shoulder pain with a documented right rotator cuff tear will be screened for eligibility and participation. Rotator cuff tear subjects will be recruited under consultation with physicians from their patient populations. Patient charts will be assessed by study investigators to ensure they meet inclusion/exclusion criteria prior to consent. Healthy subjects will be recruited by flyer and word of mouth from the surrounding general population. Healthy subjects will be of similar demographics to the rotator cuff tear subjects.

You may qualify if:

• All subjects
• 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.

You may not qualify if:

• Unable to achieve 30º of external rotation and 140º of elevation in the scapular plane, where the limitations are not due to cuff tear associated pain.
• 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.

Sponsors & Collaborators

• More Foundation: lead
• DePuy Synthes Products, Inc.: collaborator

Study Sites (1)

MORE Foundation

Phoenix, Arizona, 85023, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Marc D Jacofsky, PhD

  More Foundation

  STUDY DIRECTOR

Central Study Contacts

John D McCamley, PhD

CONTACT

634.241.8721; john.mccamley@more-foundation.org

Debra Sietsema, PhD

CONTACT

623.455.7109; debra.sietsema@more-foundation.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2020
• First Posted: October 1, 2020
• Study Start: January 28, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

US (1)