- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04388306
Shoulder Functional Performance After Shoulder Surgery
Functional Performance of Shoulder After Arthroscopic Rotator Cuff Repair and Investigation of Performance Related Factors
Rotator Cuff (RC) injuries are a progressive clinical condition that starts with an acute tendonitis, continues with partial thickness rupture and results in a full thickness rupture in the advanced period.
Arthroscopic RC repair is effective in the acute RC ruptures treatment caused by traumatic events. In the acute period after arthroscopic RC repair, shoulder joint range of motion (ROM), muscle strength and shoulder functionality are decreased and daily activities are adversely affected. In the long-term, many studies have reported that these symptoms gradually decreaced.
Many studies investigating postoperative treatment of RC rupture have mostly focused on parameters such as postoperative pain, functionality, muscle strength, ROM and quality of life.Evaluation of these clinical parameters is necessary for patient follow-up in the early period. However, it is unclear whether the biomechanical etiologic factors continue that lead to RC rupture in the advanced period after surgery.
Therefore, the objective of this study was functional performance of shoulder after arthroscopic Rotator Cuff repair and ınvestigation of performance related factors.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Central
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Bolu, Central, Turkey, 14000
- Bolu Abant İzzet Baysal Üniversity
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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:
- With the same RC surgical procedure and technique,
- With acromioplasty and/or tenodesis with RC repair,
- Undergoing arthroscopic RC repair from the upper extremity of the dominant side,
- Having completed the 12th week after surgery,
- Performing 90° and above active shoulder elevation movement
Exclusion Criteria:
- Having undergone revision surgery or previous shoulder surgery, a history of fracture of the upper extremity
- Having undergone surgery causing limitation of motion in the spine,
- Having a neurological and/or vestibular and/or rheumatologic disease,
- Participants with diabetes mellitus, hypertension, cardiovascular and chronic respiratory disease that may cause problems during the test
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study Group
Thirty-two participants with undergone arthroscopic Rotator Cuff repair
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Participants were evaluated with all tests, respectively.
To eliminate the fatigue factor, 5 minutes breaks were given after each test.
Other Names:
|
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Control Group
Thirty-two healthy participants
|
Participants were evaluated with all tests, respectively.
To eliminate the fatigue factor, 5 minutes breaks were given after each test.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)
Time Frame: Three months
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FIT-HaNSA is a test battery consisting of 3 tasks simulating overhead work and lifting activities designed to evaluate the shoulder functional performance.
|
Three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Constant Murley Score
Time Frame: Three months
|
Shoulder functionality was analyzed by using the MCMS evaluating pain, daily living activities, ROM and strength.
Pain was evaluated by visual analog scale and ROM by goniometer.
The force in the shoulder abduction position was measured with the Digital analyzer defined by the spring balance technique.
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Three months
|
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Scapular Muscle Endurance Test
Time Frame: Three months
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The scapular muscle endurance test evaluate the endurance of the serratus anterior and the trapezium muscles.
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Three months
|
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Total Upper Extremity Muscle Strength
Time Frame: Three months
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Total upper extremity muscle strength was evaluated with Jamar hand dynamometer.
Grip strength is considered to be a valid value of TUEMS.
The test was performed by measuring both sides.
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Three months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Beyza YAZGAN DAĞLI, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- AIBU-FTR-BYD-01
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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