Actively Recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair: A Prospective, Randomized, Parallel-Group, Evaluator-Blinded Study
Led by Samsung Medical Center · Updated on 2025-12-01
70
Participants Needed
1
Research Sites
N/A
Total Duration
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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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be an adult aged 19 or older
- Have a diagnosis of rotator cuff tear or related shoulder tendon/muscle injury and have undergone rotator cuff repair surgery, including combined procedures
- Own a smartphone operating on Android or iOS
- Have received a full explanation of the trial, understood it, voluntarily agreed to participate, and provided written consent
You will not qualify if you...
- Previous rotator cuff repair surgery on the same site (revision surgery)
- Planning or recommended to have rotator cuff repair surgery on the opposite shoulder within one year after enrollment
- Plans to receive manual therapy or invasive procedures at the surgical site at another hospital within one year after discharge
- Severe underlying conditions or comorbidities that prevent participation in rehabilitation exercises
- Difficulty using the trial medical devices due to cognitive impairment, visual impairment, or digital illiteracy
- Any other condition judged by medical staff as a contraindication for unsupervised rehabilitation or deemed unsuitable by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 20 weeks
Participants receive digital therapeutics through a personal mobile device or usual care including education and physical therapy following rotator cuff repair surgery.
Visits around 2, 8, and 20 weeks after surgery
Duration - Up to 46 weeks post-surgery
Participants continue to be monitored for shoulder function and pain through follow-up assessments up to 46 weeks after surgery.
Assessments at 9, 15, 22, and 46 weeks post-surgery
Trial Site Locations
Total: 1 location
1
Samsung medical center
Seoul, Republic of Korea, South Korea, 06351
Actively Recruiting
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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