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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06156423
Other study ID # E-60116787-020-390737
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 10, 2023
Est. completion date August 2025

Study information

Verified date December 2023
Source Pamukkale University
Contact Sinem Yenil
Phone +902582964284
Email sinemyenil_96@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date August 2025
Est. primary completion date April 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Motor control exercise
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.
Standard exercise
The standard rehabilitation group received a rehabilitation program via video call 3 days a week for 12 weeks.

Locations

Country Name City State
Turkey Sinem Yenil Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Assessment 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
Primary Shoulder Range of Motion Assessment 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
Primary Active Internal Rotation Assessment 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
Primary Scapular Dyskinesis Assessment Scapular dyskinesis will be evaluated with the lateral scapular glide test. Preoperative, postoperative 6th week and postoperative 12th week
Primary Shoulder muscle strength assessment Shoulder abduction, flexion, internal and external rotation and scaption muscle strength will be measured with a dynamometer. Preoperative and postoperative 12th week
Primary Grip strength assessment Grip strength will be evaluated with a Jamar hand dynamometer. Preoperative and postoperative 12th week
Primary Shoulder function assessment 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
Primary Shoulder function assessment 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). Preoperative, postoperative 6th week and postoperative 12th week
Primary Kinesiophobia Assessment 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. Preoperative, postoperative 6th week and postoperative 12th week
Primary Sleep quality assessment 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. Preoperative, postoperative 6th week and postoperative 12th week
Primary Quality of Life Assessment 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. Preoperative, postoperative 6th week and postoperative 12th week
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