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.

• Change in active range of motion of the operated shoulder from baseline to 24 weeks [Срок оценки: Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively]
• Change in isometric shoulder strength from baseline to 24 weeks [Срок оценки: Assessed at baseline (pre-operative), 12 weeks, and 24 weeks post-operatively]
• Change in pain intensity (VAS) at rest and during activity from baseline to 24 weeks [Срок оценки: Assessed at baseline (pre-operative), 6 weeks, 12 weeks, and 24 weeks post-operatively]
• Change in Tampa Scale for kinesiophobia (TSK-11) from baseline to 24 weeks [Срок оценки: Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively.]
• Rotator cuff re-tear rate at 24 weeks post-operatively [Срок оценки: At 24 weeks after arthroscopic rotator cuff repair]
• Time and level of return to work at 24 weeks [Срок оценки: Assessed at 12 weeks and 24 weeks post-operatively]
• Change in Health-related quality of life (EQ-5D-5L) at 24 weeks [Срок оценки: Assessed at 24 weeks post-operatively]
• Change in Self-Efficacy for Rehabilitation Scale (SER) at 24 weeks [Срок оценки: Assessed at 6 weeks, 12 weeks, and 24 weeks post-operatively]
• Change from baseline in Exercise Adherence Rating Scale (EARS) at 24 weeks. [Срок оценки: 6 weeks, 12 weeks, 24 weeks post-operatively]
• Total Direct Non-Medical Costs at 24 weeks. [Срок оценки: 24 weeks (accumulated from baseline)]
• Caregiver Productivity Loss at 24 weeks [Срок оценки: 24 weeks (accumulated from baseline)]