Rotator Cuff Tear ArthropathyNCT07255534
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
A study testing digital therapeutics in people with Rotator Cuff Tear Arthropathy and Repair of a Cuff Tear, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
- What is being tested?
- digital therapeutics
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Oct 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Own a smartphone operating on the Android or iOS platform.
- Have received a full explanation of this clinical trial, understood it, voluntarily agreed to participate, and provided written consent to comply with study precautions.
Who cannot join
- History of previous rotator cuff repair surgery on the same site (revision surgery).
- Planning or recommendation by medical staff for contralateral rotator cuff repair surgery within one year after enrollment.
- Plans to receive direct manual therapy or invasive procedures (e.g., oriental medicine treatments, injections, regenerative therapies) at the surgical site through inpatient or outpatient care 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 hinder participation in rehabilitation exercises.
- Difficulty using clinical trial medical devices due to cognitive impairment (e.g., dementia), visual impairment, or digital illiteracy.
- Other cases where the medical staff judges that unsupervised rehabilitation exercise is contraindicated or the principal investigator deems the subject unsuitable for the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair: A Prospective, Randomized, Parallel-Group, Evaluator-Blinded Study
- 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.
- 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.
- 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.
- 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.
- Being tested
- digital therapeutics, usual care
- Keywords
- Rotator Cuff Tear Arthropathy, repair of a cuff tear, digital therapeutics, rehabilitarion
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital therapeuticsOther
After rotator cuff repair surgery, the patient performed prescribed rehabilitation exercises delivered through a personal mobile device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intrevention group (digital therapeutics) | Experimental | Not described Receives: Other: digital therapeutics; Other: usual care |
| control group (usual care) | Active comparator | Not described Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeons score (ASES)
domain : pain, function
- Pain is measured using a Visual Analog Scale (VAS) rated out of 10 points and then converted to a 50-point scale.
- 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.
Measured: baseline, 9-week, 15-week, 22-week, 46-week
Secondary outcomes (9)
Constant score
The scoring system ranges from 0 to 100 points, with higher scores indicating better shoulder function. It includes the following components: pain (15 points), activities of daily living (20 points), active range of motion (ROM) (40 points), and muscle strength (25 points). Muscle strength is measured by assessing force in 90-degree shoulder abduction and then converted into a score.
Measured: baseline, 9-week, 22-week, 46-week
Korean shoulder Score (KSS)
The scale ranges from 0 to 100 points, with higher scores indicating better function. It is composed of the following components: pain (30 points), function (40 points), activities of daily living (10 points), muscle strength (20 points), and satisfaction (10 points).
Measured: baseline, 9-week, 22-week, 46-week
Simple shoulder Test (SST)
The score ranges from 0 to 12 points, with higher scores indicating better function. It is an outcome measure consisting of 12 yes/no questions related to function. Each "yes" response is scored as 1 point, and the total number of "yes" answers is summed to calculate the final score. This tool provides a simple patient-reported outcome to briefly assess the ability to perform daily activities.
Measured: baseline, 9-week, 22-week, 46-week
Shoulder pain (PVAS)
Evaluated during rest and activity. Pain is assessed using an 11-point scale (0-10 points) evaluating overall shoulder pain over the past 7 days. A lower score indicates an improvement in pain.
Measured: baseline, 9-week, 15-week, 22-week, 46-week
Shoulder joint range of motion (active)
- Forward flexion (0-180 degrees), abduction (0-180 degrees), and external rotation at the side with the upper arm beside the torso (0-90 degrees) are measured using a goniometer to record the maximum angles. Higher values indicate better shoulder mobility.
- Internal rotation at the back: When the arm is placed behind the back, the level of the spine reached by the tip of the thumb is measured and scored accordingly (thoracic vertebrae T1-T12 = 1-12 points; lumbar vertebrae L1-L5 = 13-17 points; buttock = 18 points). Higher scores indicate better shoulder mobility.
Measured: 9-week, 15-week, 22-week, 46-week
Shoulder joint range of motion (passive)
- Forward flexion (0-180 degrees), abduction (0-180 degrees), and external rotation at the side with the upper arm beside the torso (0-90 degrees) are measured using a goniometer to record the maximum angles. Higher values indicate better shoulder mobility.
- Internal rotation at the back: When the arm is placed behind the back, the level of the spine reached by the tip of the thumb is measured and scored accordingly (thoracic vertebrae T1-T12 = 1-12 points; lumbar vertebrae L1-L5 = 13-17 points; buttock = 18 points). Higher scores indicate better shoulder mobility.
Measured: baseline, 9-week, 15-week, 22-week, 46-week
Shoulder muscle strength (Isokinetic)
Isokinetic muscle strength is measured for each movement following a standardized protocol using an isokinetic dynamometer (HUMAN NORM; exercise testing and evaluation device; classification number A30130.01, Class 2 medical device). During the test, the subject sits on a chair with the trunk fixed to the dynamometer. The subject holds the handle on the opposite side of the dynamometer. Higher values indicate better muscle strength.
Internal and external rotation: The arm is abducted to 45 degrees in the scapular plane with the elbow flexed to 90 degrees. External rotation range of motion is set at 65 degrees and internal rotation at 25 degrees. Measurements are taken at an angular velocity of 60 degrees per second for 4 repetitions (strength) and 180 degrees per second for 10 repetitions (muscular endurance), recording peak torque in pounds.
Measured: baseline, 22-week, 46-week
Shoulder muscle strength (Isometric)
Using a hand-held dynamometer (FGN-20B, SHIMPO, JAPAN), the maximum force (in pounds) is collected and measured in the internal rotation (at side), external rotation (at side), and scaption positions.
Measured: baseline, 9-week, 22-week, 46-week
Global change rating (GRoC)
The overall change assessment scale ranges from -5 (much worse) to 5 (much improved) points, evaluating the patient's perception of overall functional recovery and satisfaction with their general condition. Compared to pre-surgery, a change of 2 points or more at the end of intervention (T3), and similarly from T3 to the end of follow-up (T4), is interpreted as the minimum clinically important difference.
Measured: 22-week, 46-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start20 Oct 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear ArthropathyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized controlled, 1:1 allocation, total participants 70
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JiHye Hwang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07255534
- Sponsor's protocol ID
- SMC 2025-07-113-002
- Other IDs
- RS-2024-00401350
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this provides the subject's personal information to a third party, separate consent is required.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair: A Prospective, Randomized, Parallel-Group, Evaluator-Blinded Study
- ClinicalTrials.gov ID
- NCT07255534
- Acronym / sponsor ID
- SMC 2025-07-113-002
- Keywords
- Rotator Cuff Tear Arthropathy, repair of a cuff tear, digital therapeutics, rehabilitarion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized controlled, 1:1 allocation, total participants 70
| Arm | Type | Receives |
|---|---|---|
| Intrevention group (digital therapeutics) | Experimental | Other: digital therapeutics, Other: usual care |
| control group (usual care) | Active comparator | Other: usual care |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Own a smartphone operating on the Android or iOS platform.
- Have received a full explanation of this clinical trial, understood it, voluntarily agreed to participate, and provided written consent to comply with study precautions.
Key exclusion criteria (6 listed)
- History of previous rotator cuff repair surgery on the same site (revision surgery).
- Planning or recommendation by medical staff for contralateral rotator cuff repair surgery within one year after enrollment.
- Plans to receive direct manual therapy or invasive procedures (e.g., oriental medicine treatments, injections, regenerative therapies) at the surgical site through inpatient or outpatient care 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 hinder participation in rehabilitation exercises.
- Difficulty using clinical trial medical devices due to cognitive impairment (e.g., dementia), visual impairment, or digital illiteracy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital therapeuticsAfter rotator cuff repair surgery, the patient performed prescribed rehabilitation exercises delivered through a personal mobile device | Other | Intrevention group (digital therapeutics) |
| usual careBefore 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. | Other | Intrevention group (digital therapeutics), control group (usual care) |
Primary outcome
American Shoulder and Elbow Surgeons score (ASES)
Time frame: baseline, 9-week, 15-week, 22-week, 46-week
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.
9 secondary outcomes
Constant score
Time frame: baseline, 9-week, 22-week, 46-week
Korean shoulder Score (KSS)
Time frame: baseline, 9-week, 22-week, 46-week
Simple shoulder Test (SST)
Time frame: baseline, 9-week, 22-week, 46-week
Shoulder pain (PVAS)
Time frame: baseline, 9-week, 15-week, 22-week, 46-week
Shoulder joint range of motion (active)
Time frame: 9-week, 15-week, 22-week, 46-week
Shoulder joint range of motion (passive)
Time frame: baseline, 9-week, 15-week, 22-week, 46-week
Shoulder muscle strength (Isokinetic)
Time frame: baseline, 22-week, 46-week
Shoulder muscle strength (Isometric)
Time frame: baseline, 9-week, 22-week, 46-week
Global change rating (GRoC)
Time frame: 22-week, 46-week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. Since this provides the subject's personal information to a third party, separate consent is required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital therapeutics in people with Rotator Cuff Tear Arthropathy and Repair of a Cuff Tear, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons score (ASES) (time frame: baseline, 9-week, 15-week, 22-week, 46-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.