Remote App-based Rehabilitation After Rotator Cuff Repair

Shoulder pain is the third most common medical condition seen in primary care settings, with 65-70% of patients experiencing rotator cuff injuries. Therefore, rotator cuff injuries significantly impact patients' mobility and place a considerable burden on the healthcare system and employers. The majority of patients are treated conservatively; however, approximately 40% of patients with rotator cuff tears, in which the primary injury is a tear of the supraspinatus and infraspinatus tendons, experience persistent pain and require surgical intervention. Effective rehabilitation programs can address disability and functional impairments in patients, such as joint range of motion, muscle strength, and persistent pain.

However, not all patients who have undergone rotator cuff surgery have full access to in-person rehabilitation programs due to geographical, financial, and awareness barriers, or other objective factors such as epidemics. Furthermore, many patients lack the skills and knowledge to perform guided exercises at home, or receive inadequate guidance. In this context, tele-rehabilitation is considered a potential solution to mitigate the drawbacks of in-person and self-training methods.

This study was designed to address gaps in practical implementation by evaluating whether the addition of a culturally adapted smartphone-based telerehabilitation application to standard postoperative physiotherapy could improve clinical outcomes compared to using standard physiotherapy alone.

The primary objective was to determine the effectiveness of combined telerehabilitation intervention on shoulder function, as measured by changes in Constant-Murley and Quick DASH scores 24 weeks after arthroscopic repair of rotator cuff tendon injuries.

Secondary objectives include assessing the impact of the intervention on active range of motion, isotonic shoulder strength, pain intensity, specific functional capacity of the patient, psychological factors (movement anxiety and rehabilitation confidence), treatment adherence, health-related quality of life, return to work status, direct non-medical costs, and caregiver time burden. The study will also assess safety through the rate of rotator cuff re-tear after 24 weeks and investigate factors related to treatment response. The study employs a comprehensive biopsychosocial assessment. Beyond physical recovery, we evaluate the interplay between psychological barriers (kinesiophobia via TSK-11), psychological assets (self-efficacy via SER), and resulting clinical behavior (adherence via EARS) to provide a holistic view of the patient's rehabilitation journey.

This is a randomized, controlled, single-center clinical trial conducted at Viet Duc Friendship Hospital in Hanoi, Vietnam. A total of 102 patients eligible for arthroscopic rotator cuff repair are expected to be recruited and randomized in a 1:1 ratio into either the intervention or control group using a computer-generated block randomization. During the first 6 weeks post-surgery, all patients received direct instruction in physical therapy with a total of 6-8 treatment sessions. After 6 weeks, patients were divided into two groups.

Participants in the intervention group received the hospital's standard surgical physiotherapy protocol along with access to a dedicated smartphone application. This application provided daily exercise instruction videos tailored to each rehabilitation phase, automatic reminders, real-time compliance monitoring, and asynchronous communication with the physiotherapist for remote feedback and progress tracking.

Participants in the control group received only the hospital's standard surgical physiotherapy protocol and were explicitly instructed not to use any additional rehabilitation applications or online exercise programs throughout the 24-week study period.

All participants followed the same standard three-phase rehabilitation protocol developed by the hospital's Department of Rehabilitation based on the Vietnamese Ministry of Health guidelines and Massachusetts General Hospital:

Phase 1 (weeks 0-6): Assisted passive protection and movement. Phase 2 (weeks 6-12): Active movement, starting with light resistance. Phase 3 (weeks 12-24): Gradual strengthening and rehabilitation. Assessment of outcomes was planned at baseline (pre-surgery), 6 weeks, 12 weeks, and 24 weeks post-surgery. The primary endpoint was the change in Constant-Murley and Quick DASH scores from baseline to 24 weeks. Secondary criteria include active range of motion measured by an angle measuring device, isotonic shoulder strength measured by a handheld dynamometer (forward flexion, abduction, external rotation, and internal rotation), visual analog scale (VAS) for pain at rest and during activity, Patient-Specific Functional Scale (PSFS), Tampa Scale of Movement Aversion (TSK-11), Self-Effect Scale of Rehabilitation (SER), Exercise Compliance Scale (EARS), EQ-5D-5L for quality of life, time and extent of return to work, total direct non-medical costs, and number of lost workdays for caregivers. Rotator cuff tendon integrity will be assessed after 24 weeks using ultrasound or MRI.

Data will be collected using a standard electronic case report form. When participants are unable to attend in-person consultations, data collection will be conducted through structured telephone interviews or home visits by trained research staff, with the methodology clearly documented for each assessment to allow for sensitivity analysis.

The study will be conducted in full compliance with the Helsinki Declaration and the ICH Good Clinical Practice guidelines. This study has been approved by the Medical Ethics Committee of Hanoi Medical University. All participants will provide written informed consent before enrollment.

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.