Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571268
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
DePuy Synthes Products, Inc.
Information provided by (Responsible Party):
More Foundation

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Rotator Cuff Tears

Detailed Description:

Rotator cuff tears occur in approximately 20% of patients older than 65 years and increase with age. These non-traumatic RCTs are generally caused by normal age-related degeneration. Surgical treatment is effective, however recurrence of injury is common especially when the original tear was caused by age related degeneration. Non-surgical treatment options are designed to decrease pain and improve performance of activities of daily living and may be an effective alternative to surgery. If non-surgical treatment options are unsuccessful, surgical treatment may be considered. When rotator cuff tears are treated surgically, postoperative rehabilitation is an important factor in determining outcome success, however there is uncertainty regarding the best protocols for post-surgery rehabilitation. Evidence suggests that a more complete understanding of motion and muscle activation is necessary to design effective and reliable rehabilitation programs for rotator cuff injuries.

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Motions of the Bones and Activation of the Muscles of the Shoulder Girdle During Basic and Common Arm Movement
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Range of motion [ Time Frame: At enrollment ]
    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

  2. Activities of Daily Living [ Time Frame: At enrollment ]
    Measure glenohumeral joint angles and rotator cuff muscle activation patterns during the performance of prescribed activities of daily living


Secondary Outcome Measures :
  1. Patient reported outcome [ Time Frame: At enrollment ]
    Completion of QuickDASH questionnaire


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571268


Contacts
Layout table for location contacts
Contact: John D McCamley, PhD 634.241.8721 john.mccamley@more-foundation.org
Contact: Debra Sietsema, PhD 623.455.7109 debra.sietsema@more-foundation.org

Locations
Layout table for location information
United States, Arizona
MORE Foundation Recruiting
Phoenix, Arizona, United States, 85023
Contact: John D McCamley, PhD    623-241-8721    john.mccamley@more-foundation.org   
Contact: Debra Sietsema, PhD    623.455.7109    debra.sietsema@more-foundation.org   
Principal Investigator: John D McCamley, PhD         
Sub-Investigator: Courtney Mason, MS         
Sponsors and Collaborators
More Foundation
DePuy Synthes Products, Inc.
Investigators
Layout table for investigator information
Study Director: Marc D Jacofsky, PhD More Foundation
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: More Foundation
ClinicalTrials.gov Identifier: NCT04571268    
Other Study ID Numbers: 4030
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by More Foundation:
Rotator cuff tear
Shoulder motion
Shoulder muscle activation
Additional relevant MeSH terms:
Layout table for MeSH terms
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries