At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty

NCT ID: NCT06891378

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2026-06-30

Brief 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. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Conditions

Arthroplasty, Replacement, Shoulder; Reverse Total Shoulder Arthroplasty

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Intrevention group (mHealth group)

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

control group (usual care)

Intervention Type: OTHER

This group performs home rehabilitation exercises using in-hospital educational materials.

Control group data are retrospectively collected and matched using propensity score methods.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

JiHye Hwang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, Irwon-ro 81, South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Lim

Role: primary

deartojay@skku.edu

82+10-8388-4465

Other Identifiers

RS-2024-00401350

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-02-088

Identifier Type: -

Identifier Source: org_study_id