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

Samsung Medical Center

Status: Enrolling

Conditions: Reverse Total Shoulder Arthroplasty; Arthroplasty, Replacement, Shoulder

Treatments: Other: Intrevention group (mHealth group); Other: control group (usual care)

Study type: Interventional

Funder types: Other

Identifiers

NCT06891378

RS-2024-00401350 (Other Grant/Funding Number)

2025-02-088

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intrevention group (mHealth group)

Experimental group

Description:

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

Treatment:

Other: Intrevention group (mHealth group)

control group (usual care)

Active Comparator group

Description:

This group performs home rehabilitation exercises using in-hospital educational materials. Control group data are retrospectively collected and matched using propensity score methods.

Treatment:

Other: control group (usual care)