Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair

Condition(s) studied

Investigational drug(s) / intervention(s)

digital therapeutics: After rotator cuff repair surgery, the patient performed prescribed rehabilitation exercises delivered through a personal mobile device

usual care: Before discharge and at the first postoperative visit (2 weeks after surgery), patients receive education based on a brochure covering rehabilitation exercises, surgical site care, and criteria for hospital visits in emergency situations. The brochure includes information on the duration of brace use, surgical site hygiene and care, precautions for arm use, and detailed rehabilitation exercise instructions. At follow-up visits around 8 and 20 weeks post-surgery, patients receive guidance on improving joint range of motion and muscle strengthening exercises. Physical therapy modalities such as cold and heat application and electrical stimulation are provided. Additional treatments, including corticosteroid injections combined with hyaluronic acid, may be administered based on the healthcare provider's clinical judgment.

Study summary

1. Importance of Rehabilitation After Rotator Cuff Repair Rotator cuff tears are among the most common shoulder conditions in Korea. They can occur naturally with aging or result from trauma or overuse. When conservative treatments like medication or injections fail to relieve pain and restore function, rotator cuff repair surgery is necessary. Postoperative rehabilitation exercises are crucial for recovering shoulder function, reducing pain, and returning to daily activities. Many studies have emphasized the importance of staged rehabilitation and patient education after surgery, showing that active patient participation directly affects recovery. However, some patients rely on unverified internet sources (such as YouTube or online forums) or face limitations such as time, geographical constraints, or cost even when receiving face-to-face therapy.
2. Advantages of Digital Therapeutics Digital therapeutic devices have emerged as a promising solution to these challenges. These smartphone applications deliver exercise and educational content tailored to postoperative rehabilitation, aiming to improve the disease state. They offer anytime, anywhere access without time or location restrictions and provide evidence-based, systematic, and personalized rehabilitation programs. Comprehensive educational materials enhance patient understanding and promote self-management skills, potentially increasing rehabilitation adherence.
3. Recent Research Findings Digital rehabilitation programs for patients after rotator cuff repair have demonstrated effectiveness. Programs that provide real-time exercise feedback using mobile apps and sensors have shown similar or superior outcomes compared to traditional physical therapy. Augmented reality (AR)-based rehab systems are more effective in improving shoulder function than conventional methods, and digital apps offering customized exercise videos significantly enhance physical function and confidence. Notably, patients using digital rehabilitation programs for 1 to 6 months exhibited improved adherence to therapeutic exercises, facilitating consistent home-based rehabilitation.
4. Purpose of This Clinical Trial While previous studies have confirmed the efficacy and safety of digital therapeutic devices after rotator cuff surgery, most are limited to generic exercise programs. This clinical trial aims to evaluate the effectiveness and safety of a clinical trial digital therapeutic device not yet approved domestically, providing disease-specific exercise programs.

Eligibility

Primary outcome measure(s)

• American Shoulder and Elbow Surgeons score (ASES) — baseline, 9-week, 15-week, 22-week, 46-week
  domain : pain, function 1. Pain is measured using a Visual Analog Scale (VAS) rated out of 10 points and then converted to a 50-point scale. 2. Function is assessed through a questionnaire consisting of 10 items, each scored from 0 to 3, with a total raw score of 30. This total is converted to a 50-point scale. This results in a final combined score ranging from 0 to 100, with higher scores indicating better shoulder function.

Trial sites (1)

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