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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.

Outcome Measures

Primary Outcomes (1)

American Shoulder and Elbow Surgeons score (ASES)
domain : pain, function 1. Pain is measured using a Visual Analog Scale (VAS) rated out of 10 points and then converted to a 50-point scale. 2. Function is assessed through a questionnaire consisting of 10 items, each scored from 0 to 3, with a total raw score of 30. This total is converted to a 50-point scale. This results in a final combined score ranging from 0 to 100, with higher scores indicating better shoulder function.
baseline, 9-week, 15-week, 22-week, 46-week

Secondary Outcomes (9)

Constant score
baseline, 9-week, 22-week, 46-week
Korean shoulder Score (KSS)
baseline, 9-week, 22-week, 46-week
Simple shoulder Test (SST)
baseline, 9-week, 22-week, 46-week
Shoulder pain (PVAS)
baseline, 9-week, 15-week, 22-week, 46-week
Shoulder joint range of motion (active)
9-week, 15-week, 22-week, 46-week
+4 more secondary outcomes

Other Outcomes (6)

Self-efficacy for exercise (SEE)
baseline, 9-week, 15-week, 22-week, 46-week
World Health Organization Disability Assessment Schedule (WHODAS 2.0)
baseline, 9-week, 15-week, 22-week, 46-week
(K-eHEALS)
baseline
+3 more other outcomes

Interventions

digital therapeuticsOther

After rotator cuff repair surgery, the patient performed prescribed rehabilitation exercises delivered through a personal mobile device

Intrevention group (digital therapeutics)

usual careOther

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 improving joint range of motion and muscle strengthening exercises. Physical therapy modalities such as cold and heat application and electrical stimulation are provided. Additional treatments, including corticosteroid injections combined with hyaluronic acid, may be administered based on the healthcare provider's clinical judgment.

Eligibility Criteria

Age19 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

DOUBLE

Who Masked

INVESTIGATOR, OUTCOMES ASSESSOR

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Prospective, randomized controlled, 1:1 allocation, total participants 70

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Professor

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (6)

Study Arms (2)

Intrevention group (digital therapeutics)

control group (usual care)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Other Outcomes (6)

Study Arms (2)

Intrevention group (digital therapeutics)

control group (usual care)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations