- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06156423
Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery
Investigation of the Effect of Motor Control Exercises Given With Telerehabilitation on Shoulder Function and Quality of Life in Patients Undergoing Rotator Cuff Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Treatment of rotator cuff tears can be conservative or surgical. The aim of rehabilitation postoperative period, is to reduce pain, increase joint range of motion (ROM), and enable the patient to return to normal functional activities as soon as possible while preventing the repaired tissue from tearing again.
Motor control training based on motor control theory reorganizes the cerebral cortex. In people with shoulder pain, a scapulothoracic posture retraining program reduces shoulder pain and improves scapulothoracic movement and muscle activation patterns and shoulder function. Therefore, rehabilitation should include correct positioning of the scapulothoracic joint through active muscle activation (motor control training) and retraining. However, the evidence is still limited and the effect of motor control exercises is not yet fully understood. Over the last 15 years, telerehabilitation in the broader field of telehealth has been used to help patients in rural areas improve healthcare and access services to reduce cost and transportation issues. Studies on the upper extremity have also begun to increase in recent years. The aim of the study is to examine the effect of motor control exercises given through telerehabilitation on shoulder function and quality of life in patients undergoing rotator cuff surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sinem Yenil
- Phone Number: +902582964284
- Email: sinemyenil_96@hotmail.com
Study Locations
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Denizli, Turkey, 20060
- Recruiting
- Sinem Yenil
-
Contact:
- Sinem Yenil
- Phone Number: +902582964284
- Email: sinemyenil_96@hotmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergone rotator cuff surgery
- being 18 years of age
- agree to participate in the study,
- allowed early rehabilitation after surgery,
- can speak and understand Turkish
- can make video conferences and phone calls.
Exclusion Criteria:
- have had previous surgery on the affected shoulder,
- have neurological deficits and motor control disorders,
- have systemic rheumatological disease,
- have developed any complications that may affect rehabilitation in the shoulder,
- have had revision surgery on the affected shoulder.
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 |
---|---|
Experimental: Motor Control Rehabilitation
|
Motor control exercises include stabilization exercises for the scapula with external focus by activating the correct alignment and kinetic chain by providing verbal feedback and visual feedback.
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Active Comparator: Standard Rehabilitation
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The standard rehabilitation group received a rehabilitation program via video call 3 days a week for 12 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder Range of Motion Assessment
Time Frame: Preoperative, postoperative 6th week and postoperative 12th week
|
Range of motion of the shoulder will be evaluated with a electrogoniometer.
Evaluations will be made actively for shoulder flexion, abduction, internal and external rotation and active total elevation
|
Preoperative, postoperative 6th week and postoperative 12th week
|
Active Internal Rotation Assessment
Time Frame: Preoperative, postoperative 6th week and postoperative 12th week
|
In active internal rotation of the shoulder, the distance between the thumb and the T5 spinous process will be measured with a tape measure.
|
Preoperative, postoperative 6th week and postoperative 12th week
|
Scapular Dyskinesis Assessment
Time Frame: Preoperative, postoperative 6th week and postoperative 12th week
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Scapular dyskinesis will be evaluated with the lateral scapular glide test.
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Preoperative, postoperative 6th week and postoperative 12th week
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Shoulder muscle strength assessment
Time Frame: Preoperative and postoperative 12th week
|
Shoulder abduction, flexion, internal and external rotation and scaption muscle strength will be measured with a dynamometer.
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Preoperative and postoperative 12th week
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Grip strength assessment
Time Frame: Preoperative and postoperative 12th week
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Grip strength will be evaluated with a Jamar hand dynamometer.
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Preoperative and postoperative 12th week
|
Pain Assessment
Time Frame: Preoperative, postoperative 6th week and postoperative 12th week
|
Pain assessment will be evaluated with the Visual Analog Scale (VAS) before surgery, at the 6th week and at the 12th week after surgery, during activity, rest and sleep.
As the score increases, it indicates that the pain increases.
|
Preoperative, postoperative 6th week and postoperative 12th week
|
Shoulder function assessment
Time Frame: Preoperative, postoperative 6th week and postoperative 12th week
|
Shoulder function will be evaluated with Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire.
The total score is 100, with higher scores indicating more disability.
|
Preoperative, postoperative 6th week and postoperative 12th week
|
Shoulder function assessment
Time Frame: Preoperative, postoperative 6th week and postoperative 12th week
|
Other shoulder function assessment will be evaluated with American Shoulder and Elbow Surgeons Scale (ASES).
A combination of these scores will yield an ASES score ranging from 0 (absence of function) to 100 (normal function).
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Preoperative, postoperative 6th week and postoperative 12th week
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Kinesiophobia Assessment
Time Frame: Preoperative, postoperative 6th week and postoperative 12th week
|
Kinesiophobia assessment will be evaluated with Tampa Scale of Kinesiophobia.
The total score varies between 17-68.
A high score on the scale indicates that the person has a high level of kinesiophobia.
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Preoperative, postoperative 6th week and postoperative 12th week
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Sleep quality assessment
Time Frame: Preoperative, postoperative 6th week and postoperative 12th week
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Sleep quality will be evaluated with Pittsburgh Sleep Quality Index (PSQI).
The overall score ranges from 0 to 21. Lower scores indicate better sleep quality.
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Preoperative, postoperative 6th week and postoperative 12th week
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Quality of Life Assessment
Time Frame: Preoperative, postoperative 6th week and postoperative 12th week
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Quality of life will be evaluated with the Western Ontario Rotator Cuff Index (WORC), specific to rotator cuff injuries.
The total score ranges from 0 to 2100, with lower scores indicating higher quality of life.
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Preoperative, postoperative 6th week and postoperative 12th week
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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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-390737
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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