Arthroplasty, Replacement, ShoulderDHI_RTSANCT06891378
At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
A study testing Intrevention group (mHealth group) in people with Arthroplasty, Replacement, Shoulder and Reverse Total Shoulder Arthroplasty, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
1. Why This Study Matters Over the past five years, more people in Korea have been having shoulder surgery. With our country moving into a super-aged society by 2025, these surgeries are expected to increase even more. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder, Reverse Total Shoulder Arthroplasty
- What is being tested?
- Intrevention group (mHealth group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2025to 30 Mar 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those aged 50 or older
- Those who are indicated for and are scheduled to undergo reverse total shoulder arthroplasty (RTSA)
- Those who voluntarily decided to participate and gave written consent after hearing a detailed explanation of this study
Who cannot join
- Those who have difficulty using the application due to severe underlying diseases, neuromusculoskeletal diseases, cognitive or visual impairments, etc.
- Those with concomitant diseases such as neurological or visual impairments or uncontrolled cardiovascular disorders that make it difficult to participate in rehabilitation exercises
- Other people who, as determined by a medical professional, should not perform rehabilitation exercises without supervision
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mobile App-based Self-rehabilitation for Patients After Reverse Total Shoulder Arthroplasty: Pilot Non-RCT
- Why This Study Matters Over the past five years, more people in Korea have been having shoulder surgery. With our country moving into a super-aged society by 2025, these surgeries are expected to increase even more. More people today are focused on staying healthy and active, so many are choosing shoulder surgery to enjoy a better quality of life. According to the Health Insurance Review and Assessment Service, around 90,000 shoulder surgeries take place each year, and most of these patients (84.6%) are over 50.
- Reverse Shoulder Arthroplasty (RTSA) and the Role of Rehabilitation RTSA is a type of shoulder surgery often used when there's extensive damage to the shoulder's rotator cuff. Its use is growing rapidly-making up about one-third of shoulder replacements in the United States and over 90% in some European countries. Although shoulder replacement surgeries are increasing worldwide, we still need more research on the best ways to help patients recover. In particular, we want to see if using a mobile app for self-guided rehabilitation can be effective.
- The Need for Mobile App-Based Self-Rehabilitation After shoulder surgery, proper rehabilitation is crucial for a good recovery. Recent studies have shown that a mobile app can help patients easily follow their rehabilitation exercises. It also improves their understanding of the recovery process and keeps them more engaged in their treatment. Previous research has even shown that patients recovering from knee or hip replacement surgeries experienced better physical and mental recovery when using a mobile app.
- Benefits of Using Technology for Rehabilitation Studies have found that patients who use remote rehabilitation techniques gain more confidence in managing their recovery on their own rather than relying solely on regular hospital visits. In one small study, five patients who used remote rehabilitation after RTSA reported high satisfaction with their recovery process. Mobile apps also allow healthcare providers to check that patients are doing their exercises correctly and to offer timely advice. This improved communication helps patients be more proactive about their recovery.
- What This Study Aims to Do
This study will explore how mobile app-based self-rehabilitation affects recovery after shoulder replacement surgery. We will compare two groups of patients:
One group will use a mobile app to guide their rehabilitation. The other group will follow traditional rehabilitation instructions provided in a brochure.
- Being tested
- Intrevention group (mHealth group), control group (usual care)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrevention group (mHealth group)Other
- Receive a customized rehabilitation exercise program after surgery and perform rehabilitation exercises while watching videos
- Check recovery of shoulder joint range of motion
- Write an exercise diary (check exercise schedule and post-exercise condition)
- Check activity level through step count collection
- Check exercise records and contact to confirm reason if exercise was not performed
control group (usual care)Other
This group performs home rehabilitation exercises using in-hospital educational materials.
Control group data are retrospectively collected and matched using propensity score methods.
| Study group | Role | What they receive |
|---|---|---|
| Intrevention group (mHealth group) | Experimental | The main characteristics of the intervention provided to the intervention group are as follows:
1. Customized rehabilitation exercise program is assigned after surgery and rehabilitation exercise is performed while watching the video
2. Recovery of shoulder joint range of motion can be checked through movement evaluation
3. Exercise diary writing (exercise schedule and post-exercise condition can be checked)
4. Activity amount can be checked through step count collection
5. Exercise record is checked and, if exercise is not performed, reason is confirmed through contact Receives: Other: Intrevention group (mHealth group) |
| control group (usual care) | Active comparator | This group performs home rehabilitation exercises using in-hospital educational materials. Control group data are retrospectively collected and matched using propensity score methods. Receives: Other: control group (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks
It has a total range of 0 to 100 points (higher means better function). Pain is measured using the Visual Analog Scale (VAS, 10 points) and converted to 50 points, and function consists of 10 questions, each 0 to 3 points, a total of 30 points → converted to 50 points.
Measured: Before surgery, 12 weeks and 20 weeks after surgery
Secondary outcomes (9)
Shoulder function - Korean shoulder score (KSS)
The total score is 0-100 (the higher the better), and is composed of pain (30 points), function (40 points), activities of daily living (10 points), and muscle strength (20 points).
Measured: Before surgery, 12 weeks and 20 weeks after surgery
Shoulder function - Shoulder Simple Test (SST)
The total score is 0 to 12 points (the higher the better the function), and there are 12 questions related to the function, with a yes/no response method. If you answer 'yes', you get 1 point, and the number of 'yes' answers is the total score.
Measured: Before surgery, 12 weeks and 20 weeks after surgery
Shoulder function - Constant Murley Shoulder Outcome Score
Total 0~100 points (higher means better function), pain (15 points), activities of daily living (20 points), active joint range of motion (ROM) (40 points), muscle strength (25 points): Score is calculated by measuring strength in 90 degrees of abduction.
In addition, an Adjusted Cnstant score will be calculated. This is adjusted for the Normal score (total 100 points) considering differences in shoulder function according to age and gender.
Measured: Before surgery, 12 weeks and 20 weeks after surgery
Pain - Visual Analog Scale (VAS)
The higher the Visual Analog Scale (VAS, 0~10 points), the more pain there is.
Measured: Before surgery, 12 weeks and 20 weeks after surgery
Isokinetic Shoulder Mucle Strength
Isokinetic strength: Using an isokinetic strength measuring device called CSMi Medical Solutions, isokinetic strength (internal rotation, external rotation) for each movement is measured according to a standardized protocol. During the test, the subject is seated on a chair and the torso is fixed to the dynamometer. The subject is asked to hold the opposite handle of the dynamometer.
Measured: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
Active Shoulder range of moiton (degree)
- Flexion: Measure the maximum angle when the arm is raised forward according to the standard protocol.
- Abduction: Measure the maximum angle when the arm is raised sideways according to the standard protocol.
- External rotation: Collect the maximum angle measured when the arm is placed next to the trunk.
Measured: Before surgery, 12 weeks and 20 weeks after surgery
Shoulder range of moiton - internal rotation
Internal rotation: Measure the position of the thumb tip on the spine level when the arm is sent behind the back. Each position is scored. (Thoracic T1-T12 = 1-12 points; Lumbar L1-L5 = 13-17 points; Hip = 18 points)
Measured: Before surgery, 12 weeks and 20 weeks after surgery
Passive Shoulder range of moiton (degree)
- Flexion: Measure the maximum angle when the arm is raised forward according to the standard protocol.
- Abduction: Measure the maximum angle when the arm is raised sideways according to the standard protocol.
- External rotation: Collect the maximum angle measured when the arm is placed next to the trunk.
Measured: Before surgery, 12 weeks and 20 weeks after surgery
Isometric Shoulder Mucle Strength
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: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start20 Jun 2025
- Primary completion1 Feb 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, ShoulderStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This non-randomized comparative study will prospectively recruit 30 participants to receive the intervention. Additionally, a retrospective cohort of approximately 70 patients will be selected using propensity score matching to serve as a control group.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- NCT06891378
- Sponsor's protocol ID
- 2025-02-088
- Other IDs
- RS-2024-00401350
- Acronym
- DHI_RTSA
- Status last verified
- Oct 2026
- First submitted
- 14 Mar 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mobile App-based Self-rehabilitation for Patients After Reverse Total Shoulder Arthroplasty: Pilot Non-RCT
- ClinicalTrials.gov ID
- NCT06891378
- Acronym / sponsor ID
- DHI_RTSA / 2025-02-088
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 24 Mar 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.
- Why This Study Matters Over the past five years, more people in Korea have been having shoulder surgery. With our country moving into a super-aged society by 2025, these surgeries are expected to increase even more. More people today are focused on staying healthy and active, so many are choosing shoulder surgery to enjoy a better quality of life. According to the Health Insurance Review and Assessment Service, around 90,000 shoulder surgeries take place each year, and most of these patients (84.6%) are over 50.
- Reverse Shoulder Arthroplasty (RTSA) and the Role of Rehabilitation RTSA is a type of shoulder surgery often used when there's extensive damage to the shoulder's rotator cuff. Its use is growing rapidly-making up about one-third of shoulder replacements in the United States and over 90% in some European countries. Although shoulder replacement surgeries are increasing worldwide, we still need more research on the best ways to help patients recover. In particular, we want to see if using a mobile app for self-guided rehabilitation can be effective.
- The Need for Mobile App-Based Self-Rehabilitation After shoulder surgery, proper rehabilitation is crucial for a good recovery. Recent studies have shown that a mobile app can help patients easily follow their rehabilitation exercises. It also improves their understanding of the recovery process and keeps them more engaged in their treatment. Previous research has even shown that patients recovering from knee or hip replacement surgeries experienced better physical and mental recovery when using a mobile app.
- Benefits of Using Technology for Rehabilitation Studies have found that patients who use remote rehabilitation techniques gain more confidence in managing their recovery on their own rather than relying solely on regular hospital visits. In one small study, five patients who used remote rehabilitation after RTSA reported high satisfaction with their recovery process. Mobile apps also allow healthcare providers to check that patients are doing their exercises correctly and to offer timely advice. This improved communication helps patients be more proactive about their recovery.
- What This Study Aims to Do
This study will explore how mobile app-based self-rehabilitation affects recovery after shoulder replacement surgery. We will compare two groups of patients:
One group will use a mobile app to guide their rehabilitation. The other group will follow traditional rehabilitation instructions provided in a brochure.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This non-randomized comparative study will prospectively recruit 30 participants to receive the intervention. Additionally, a retrospective cohort of approximately 70 patients will be selected using propensity score matching to serve as a control group.
| Arm | Type | Receives |
|---|---|---|
| Intrevention group (mHealth group) | Experimental | Other: Intrevention group (mHealth group)The main characteristics of the intervention provided to the intervention group are as follows: 1. Customized rehabilitation exercise program is assigned after surgery and rehabilitation exercise is performed while watching the video 2. Recovery of shoulder joint range of motion can be checked through movement evaluation 3. Exercise diary writing (exercise schedule and post-exercise condition can be checked) 4. Activity amount can be checked through step count collection 5. Exercise record is checked and, if exercise is not performed, reason is confirmed through contact |
| control group (usual care) | Active comparator | Other: control group (usual care)This group performs home rehabilitation exercises using in-hospital educational materials. Control group data are retrospectively collected and matched using propensity score methods. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those aged 50 or older
- Those who are indicated for and are scheduled to undergo reverse total shoulder arthroplasty (RTSA)
- Those who voluntarily decided to participate and gave written consent after hearing a detailed explanation of this study
Key exclusion criteria (3 listed)
- Those who have difficulty using the application due to severe underlying diseases, neuromusculoskeletal diseases, cognitive or visual impairments, etc.
- Those with concomitant diseases such as neurological or visual impairments or uncontrolled cardiovascular disorders that make it difficult to participate in rehabilitation exercises
- Other people who, as determined by a medical professional, should not perform rehabilitation exercises without supervision
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 |
|---|---|---|
| Intrevention group (mHealth group)1. Receive a customized rehabilitation exercise program after surgery and perform rehabilitation exercises while watching videos 2. Check recovery of shoulder joint range of motion 3. Write an exercise diary (check exercise schedule and post-exercise condition) 4. Check activity level through step count collection 5. Check exercise records and contact to confirm reason if exercise was not performed | Other | Intrevention group (mHealth group) |
| control group (usual care)This group performs home rehabilitation exercises using in-hospital educational materials. Control group data are retrospectively collected and matched using propensity score methods. | Other | control group (usual care) |
Primary outcome
Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks
Time frame: Before surgery, 12 weeks and 20 weeks after surgery
It has a total range of 0 to 100 points (higher means better function). Pain is measured using the Visual Analog Scale (VAS, 10 points) and converted to 50 points, and function consists of 10 questions, each 0 to 3 points, a total of 30 points → converted to 50 points.
9 secondary outcomes
Shoulder function - Korean shoulder score (KSS)
Time frame: Before surgery, 12 weeks and 20 weeks after surgery
Shoulder function - Shoulder Simple Test (SST)
Time frame: Before surgery, 12 weeks and 20 weeks after surgery
Shoulder function - Constant Murley Shoulder Outcome Score
Time frame: Before surgery, 12 weeks and 20 weeks after surgery
Pain - Visual Analog Scale (VAS)
Time frame: Before surgery, 12 weeks and 20 weeks after surgery
Isokinetic Shoulder Mucle Strength
Time frame: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
Active Shoulder range of moiton (degree)
Time frame: Before surgery, 12 weeks and 20 weeks after surgery
Shoulder range of moiton - internal rotation
Time frame: Before surgery, 12 weeks and 20 weeks after surgery
Passive Shoulder range of moiton (degree)
Time frame: Before surgery, 12 weeks and 20 weeks after surgery
Isometric Shoulder Mucle Strength
Time frame: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
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 6 Nov 2026.
- Individual participant dataSharing planned: No. Since this provides the subject's personal information to a third party, separate consent is required.
Related trials for Arthroplasty, Replacement, Shoulder
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Active, not recruiting
INHANCE Stemless Reverse Shoulder IDE
Arthroplasty, Replacement
RecruitingPhase 4
Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
Total Shoulder Arthroplasty
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
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 Intrevention group (mHealth group) in people with Arthroplasty, Replacement, Shoulder and Reverse Total Shoulder Arthroplasty, 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 3 inclusion and 3 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 6 Nov 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?
Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks (time frame: Before surgery, 12 weeks and 20 weeks after surgery). 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 6 Nov 2026.