- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571268
Motions of the Bones and Activation of the Muscles of the Shoulder Girdle During Basic and Common Arm Movement
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Debra Sietsema, PhD
- Phone Number: 623.455.7109
- Email: debra.sietsema@more-foundation.org
Study Contact Backup
- Name: John D McCamley, PhD
- Phone Number: 634.241.8721
- Email: john.mccamley@more-foundation.org
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85023
- Recruiting
- More Foundation
-
Contact:
- Debra Sietsema, PhD
- Phone Number: 623.455.7109
- Email: debra.sietsema@more-foundation.org
-
Contact:
- John D McCamley, PhD
- Phone Number: 623-241-8721
- Email: john.mccamley@more-foundation.org
-
Principal Investigator:
- John D McCamley, PhD
-
Sub-Investigator:
- Courtney Mason, MS
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At enrollment
|
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
|
At enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient reported outcome
Time Frame: At enrollment
|
Completion of QuickDASH questionnaire
|
At enrollment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Marc D Jacofsky, PhD, More Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4030
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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