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NCT07555704
Remote App-based Rehabilitation After Rotator Cuff Repair
Conditions: Rotator Cuff Tear, Telemedecine, Rotator Cuff Injuries
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 102
Sponsor: Hanoi Medical University
Location: Hanoi Medical University Hanoi
Summary
The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control group receiving standard paper-based exercise instructions. The study aimed to compare the effectiveness of rehabilitation, treatment adherence, cost savings, and patient satisfaction between the two methods over a 6-month follow-up period.
Eligibility Criteria
Inclusion Criteria:
* Demographics: Individuals aged 18 years or older.
* Diagnosis: Confirmed symptomatic rotator cuff tear requiring surgical intervention, specifically involving:
* Clinical Presentation: Persistent shoulder pain and functional deficits (e.g., positive impingement signs or weakness in abduction/external rotation) consistent with rotator cuff pathology.
* Radiological Confirmation: Imaging evidence (MRI or high-resolution ultrasound) of a full-thickness supraspinatus and/or infraspinatus tendon tear.
* Tear Characteristics: Small-to-medium-sized tears (maximum diameter \< 5 cm) categorized as reparable by the attending surgeon.
* Surgical Procedure: Patients undergoing primary arthroscopic rotator cuff repair (ARCR) utilizing a standardized double-row suture bridge technique.
* Rehabilitation Adherence: Commitment to follow the standardized postoperative rehabilitation protocol as prescribed by the study.
* Cognitive and Functional Capacity:
* Absence of cognitive impairment, with the ability to comprehend and execute complex exercise instructions.
* Proficiency in digital literacy, including the regular use of an internet-enabled electronic device (smartphone, tablet, or computer) capable of video-based communication and data transmission.
* Documentation and Consent:
* Availability of comprehensive medical records, including pre- and postoperative clinical and radiological data.
* Provision of written informed consent by the patient or a legal representative prior to enrollment
Exclusion Criteria:
* Pre-existing or concomitant upper extremity dysfunction unrelated to the rotator cuff tear, including cervical disc herniation, cerebrovascular accident (stroke), traumatic brain injury, cervical spinal cord injury, rheumatoid arthritis with shoulder involvement, or brachial plexus injury.
* Complex or irreparable rotator cuff tears, defined as large or massive tears (\> 5 cm), high-grade fatty infiltration of the rotator cuff muscles (Goutallier grade ≥ 3), or inability to achieve secure tendon repair using sutures during arthroscopic surgery.
* Postoperative complications that significantly interfere with rehabilitation, such as surgical site infection, nerve injury with paralysis, or severe deltoid muscle damage.
* Severe comorbidities that may substantially affect the rehabilitation process or patient safety, including acute coronary syndrome, recent stroke, uncontrolled diabetes mellitus, or other debilitating systemic diseases.
* Inability or unwillingness to comply with the study protocol, including failure to attend scheduled follow-up assessments or voluntary withdrawal from the study.
Source: ClinicalTrials.gov (NCT07555704). StuddyBuddy aggregates publicly available trial information.