Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT07255534

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

Led by Samsung Medical Center · Updated on 2025-12-01

70

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be an adult aged 19 or older.
  • Have a diagnosis matching Korean Standard Classification of Diseases codes M75.1 or S46.08 and have undergone rotator cuff repair surgery, alone or combined with procedures like acromioplasty, biceps tenotomy, fixation, or labrum repair.
  • Own a smartphone running Android or iOS.
  • Have received full explanation of the trial, understood it, voluntarily agreed to participate, and provided written consent to follow study precautions.
Not Eligible

You will not qualify if you...

  • History of previous rotator cuff repair surgery on the same site (revision surgery).
  • Planning or recommendation for contralateral rotator cuff repair surgery within one year after enrollment.
  • Plans to receive direct manual therapy or invasive treatments at the surgical site 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 prevent participation in rehabilitation.
  • Difficulty using the study medical devices due to cognitive impairment, visual impairment, or digital illiteracy.
  • Other cases judged by medical staff or principal investigator as unsuitable or contraindicated for unsupervised rehabilitation exercise or study participation.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Samsung medical center

Seoul, Republic of Korea, South Korea, 06351

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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