Recruiting

Observational Study

Sponsor:

More Foundation

Code:

NCT04571268

Conditions

Rotator Cuff Tears

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT04571268

Start date

Jan 28, 2019

Status verified date

Oct, 2021

Completion date

Dec 30, 2022

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • Range of motion [ Time Frame: At enrollment ]
  • Activities of Daily Living [ Time Frame: At enrollment ]

Central Contacts and Locations

Locations

MORE Foundation

Recruiting

Phoenix, Arizona, United States, 85023

Contacts

Principal Investigator:

John D McCamley, PhD

More Information

Sponsor

More Foundation

Last update posted

Oct 6, 2021

Last verified

Oct, 2021

Keywords

  • Rotator cuff tear
  • Shoulder motion
  • Shoulder muscle activation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by More Foundation on 2021-10-06.