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Evaluating the Safety and Effectiveness of Digital Therapeutics to Improve Shoulder Function After Rotator Cuff Repair Surgery A Prospective, Randomized, Double-Blind Study Comparing Digital Therapy to Usual Care
Led by Samsung Medical Center · Updated on 2025-12-01
70
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Rotator cuff tears are common shoulder problems that may result from aging, injury, or overuse. When treatments like medication or injections do not relieve pain or restore function, surgery to repair the rotator cuff is needed. Rehabilitation exercises after surgery are important to regain shoulder function, reduce pain, and return to daily activities. This trial focuses on evaluating a digital therapeutic device designed to provide disease-specific exercise programs for patients after rotator cuff repair surgery, aiming to improve rehabilitation outcomes and patient adherence. Participants will be randomly assigned to one of two groups an experimental group using digital therapeutics delivered through a personal mobile device, or a control group receiving usual care. The usual care group receives education via brochures and follow-up visits that include physical therapy modalities and possible additional treatments as deemed necessary. The digital therapeutics group follows prescribed rehabilitation exercises through a smartphone app tailored to post-surgery recovery. The study includes multiple follow-up visits to monitor progress. During the study, participants will be assessed at various time points using several shoulder function scores, pain assessments, range of motion measurements, muscle strength tests, and global change ratings. These evaluations occur from baseline up to 46 weeks after surgery. The study will monitor adherence to rehabilitation and measure the effectiveness and safety of the digital therapeutic device compared to usual care. Participants are expected to be involved throughout the study duration, attending scheduled assessments and following assigned rehabilitation protocols.
CONDITIONS
Brief Title
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
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