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NCT07555704

Remote App-based Rehabilitation After Rotator Cuff Repair

Sponsor: Hanoi Medical University

View on ClinicalTrials.gov

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.

Official title: Effectiveness of a Combined Intervention Incorporating a Remote Rehabilitation Application for Patients After Arthroscopic Repair of Rotator Cuff Tears: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2026-10-01

Completion Date

2027-12-31

Last Updated

2026-09-22

Healthy Volunteers

Conditions

Rotator Cuff Tear Telemedecine Rotator Cuff Injuries

Interventions

PROCEDURE

Telerehabilitation

High-quality instructional videos on each stage of the personalized exercise program, with AI-assisted observation and correction for post-surgical rotator cuff tendon repair. Daily automated reminders to keep patients informed of their exercise schedule. Interactive digital log to record completed sessions and pain levels. Asynchronous communication with a physical therapist for guidance and program adjustments. The program is designed to enhance treatment adherence and track patient progress in real time throughout the 6-month rehabilitation period.

PROCEDURE

Conventional home exercise program

The control intervention consists of a conventional home-based exercise program. Patients will receive: During the first 6 weeks, patients will be trained directly by a physical therapist. A printed brochure containing static illustrations and written step-by-step instructions for the post-operative rotator cuff rehabilitation protocol. Standard verbal education from a physiotherapist during the directly training session. Having digital mobile reminders one time per week; patients are expected to manage their exercise frequency independently. Communication with the medical team is limited to scheduled follow-up visits at the hospital and when called by mobile. This group serves as the active comparator to evaluate the added value of the digital mobile application intervention.

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.

Locations (1)

Hanoi Medical University

Hanoi, Vietnam