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

Official title

Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair: A Prospective, Randomized, Parallel-Group, Evaluator-Blinded Study

Overview

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.

Interventions

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

Primary outcome measures

• American Shoulder and Elbow Surgeons score (ASES) [Time frame: baseline, 9-week, 15-week, 22-week, 46-week]

Secondary outcome measures (9)

• Constant score [Time frame: baseline, 9-week, 22-week, 46-week]
• Korean shoulder Score (KSS) [Time frame: baseline, 9-week, 22-week, 46-week]
• Simple shoulder Test (SST) [Time frame: baseline, 9-week, 22-week, 46-week]
• Shoulder pain (PVAS) [Time frame: baseline, 9-week, 15-week, 22-week, 46-week]
• Shoulder joint range of motion (active) [Time frame: 9-week, 15-week, 22-week, 46-week]
• Shoulder joint range of motion (passive) [Time frame: baseline, 9-week, 15-week, 22-week, 46-week]
• Shoulder muscle strength (Isokinetic) [Time frame: baseline, 22-week, 46-week]
• Shoulder muscle strength (Isometric) [Time frame: baseline, 9-week, 22-week, 46-week]
• Global change rating (GRoC) [Time frame: 22-week, 46-week]

Eligibility criteria

Inclusion criteria

• Be an adult aged 19 or older.
• Have a diagnosis corresponding to Korean Standard Classification of Diseases codes M75.1 (rotator cuff tear) or S46.08 (other specified injuries of tendons and muscles at shoulder and upper arm), and have undergone rotator cuff repair (RCR) surgery, or RCR combined with procedures such as acromioplasty, biceps tenotomy, fixation, or labrum repair.
• Own a smartphone operating on the Android or iOS platform.
• Have received a full explanation of this clinical trial, understood it, voluntarily agreed to participate, and provided written consent to comply with study precautions.

Exclusion criteria

• History of previous rotator cuff repair surgery on the same site (revision surgery).
• Planning or recommendation by medical staff for contralateral rotator cuff repair surgery within one year after enrollment.
• Plans to receive direct manual therapy or invasive procedures (e.g., oriental medicine treatments, injections, regenerative therapies) at the surgical site through inpatient or outpatient care at another hospital within one year post-discharge.
• Presence of severe underlying conditions, neuromusculoskeletal disorders, visual impairment, uncontrolled diabetes, cardiovascular disorders, or other comorbidities that hinder participation in rehabilitation exercises.
• Difficulty using clinical trial medical devices due to cognitive impairment (e.g., dementia), visual impairment, or digital illiteracy.
• Other cases where the medical staff judges that unsupervised rehabilitation exercise is contraindicated or the principal investigator deems the subject unsuitable for the clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Samsung medical center — Seoul

Identifiers

NCT: NCT07255534 · SMC 2025-07-113-002 · RS-2024-00401350

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗