- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07309796
Strengthening Exercises for Humeral Head Depressor Muscles
The Effect of Strengthening Exercises for Humeral Head Depressor Muscles on Clinical Outcomes After Reverse Shoulder Arthroplasty
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Caner KARARTI, Assoc. Prof.
- Phone Number: 903862805362
- Email: fzt.caner.92@gmail.com
Study Locations
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-
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Kırşehir, Turkey (Türkiye), 40100
- Recruiting
- Kırşehir Ahi Evran University
-
Contact:
- CANER KARARTI, PT, PhD
- Email: fzt.caner.92@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients scheduled for primary reverse total shoulder arthroplasty Intact teres minor confirmed by physical examination (Hornblower's test) and intraoperative assessment Ability to participate in physiotherapy or a home exercise program
Exclusion Criteria:
- Active infection Deltoid muscle insufficiency Inability or unwillingness to comply with randomization Prior shoulder arthroplasty on the same side Unwillingness to participate Inability to read or understand written instructions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Rehabilitation Group
Participants undergoing reverse shoulder arthroplasty will receive a standard conventional rehabilitation program starting at postoperative 6 th week . The patient will receive treatment 5 days a week for 6 weeks, for a total of 30 sessions. The program consists of passive, active-assisted, and active/resisted exercises. Exercises Included: Passive / Assisted
|
After randomization and baseline assessments, participants will undergo a standard 6-week postoperative shoulder rehabilitation program, consisting of range-of-motion exercises, scapular stabilization training, and progressive strengthening.
No additional depressor muscle-specific exercises will be applied.
|
|
Experimental: Depressor Muscle Strengthening Program
Participants will receive specific strengthening exercises targeting the shoulder depressor muscles in addition to the conventional rehabilitation program. These exercises will be performed throughout the 6-week intervention period. Additional Exercises: Latissimus dorsi: Seated rowing exercise - 3 sets × 10 repetitions Pectoralis major: Supine fly exercise - 3 sets × 10 repetitions Teres major: Prone shoulder adduction, extension, and internal rotation exercise |
After randomization and baseline assessments, participants will undergo a standard 6-week postoperative shoulder rehabilitation program, consisting of range-of-motion exercises, scapular stabilization training, and progressive strengthening.
No additional depressor muscle-specific exercises will be applied.
After randomization and baseline assessments, participants will receive a 6-week rehabilitation program consisting of conventional postoperative shoulder rehabilitation combined with a specific strengthening protocol targeting the shoulder depressor muscles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity (Visual Analog Scale - VAS)
Time Frame: 6 weeks
|
Pain intensity will be assessed using the Visual Analog Scale, a 10-cm line ranging from "no pain" to "worst imaginable pain."
The distance from the "no pain" anchor to the participant's mark will be measured in millimeters (0-100 mm), with higher scores indicating higher pain intensity.
|
6 weeks
|
|
Upper Extremity Disability (Disabilities of the Arm, Shoulder and Hand Questionnaire - DASH)
Time Frame: 6 weeks
|
The DASH is a 30-item self-administered questionnaire assessing upper-extremity functional limitations.
Items are scored 1-5 and converted to a 0-100 scale, where higher scores indicate greater disability.
|
6 weeks
|
|
Shoulder Range of Motion (ROM)
Time Frame: 6 weeks
|
Active shoulder flexion, abduction, external rotation, and internal rotation will be measured using a standard goniometer.
Results will be recorded in degrees (°).
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shoulder Function (American Shoulder and Elbow Surgeons Score - ASES)
Time Frame: 6 weeks
|
The ASES score includes pain and functional assessments, yielding a total score between 0 and 100.
Higher scores represent better shoulder function.
|
6 weeks
|
|
Thoracic Kyphosis Angle (Spinal Mouse Assessment)
Time Frame: 6 weeks
|
Thoracic spine curvature will be evaluated using the Spinal Mouse device during flexion and extension.
The system provides non-invasive, objective measurements of thoracic kyphosis.
|
6 weeks
|
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Pain Catastrophizing (Pain Catastrophizing Scale - PCS)
Time Frame: 6 weeks
|
The PCS consists of 13 items assessing rumination, magnification, and helplessness.
Total scores range from 0 to 52, with higher scores indicating greater catastrophizing.
|
6 weeks
|
|
Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)
Time Frame: 6 weeks
|
HADS includes 14 items (7 anxiety, 7 depression), each scored 0-3.
Higher scores indicate higher levels of anxiety or depression.
|
6 weeks
|
|
Kinesiophobia (Tampa Scale of Kinesiophobia - TSK)
Time Frame: 6 weeks
|
The TSK is a 17-item tool measuring fear of movement and reinjury.
Scores range between 17 and 68, with higher scores indicating greater kinesiophobia.
|
6 weeks
|
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Quality of Life (12-Item Short-Form Health Survey - SF-12)
Time Frame: 6 weeks
|
The SF-12 generates Physical Component Summary (PCS) and Mental Component Summary (MCS) scores ranging from 0 to 100.
Higher scores reflect better health-related quality of life.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 20251224
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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