Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT07255534
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Sponsor:
Samsung Medical Center
Organization:
Study Overview
Official Title:
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair: A Prospective, Randomized, Parallel-Group, Evaluator-Blinded Study
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RS-2024-00401350 | OTHER_GRANT | Korea Health Industry Development Institute | View |