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

NCT06891378 | Recruiting

• 2 other identifiers: 2025-02-088RS-2024-00401350
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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. 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. 5.What This Study Aims to Do

Conditions

Arthroplasty, Replacement, Shoulder; Reverse Total Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

  Before surgery, 12 weeks and 20 weeks after surgery

Secondary Outcomes (9)

• Shoulder function - Korean shoulder score (KSS)

  Before surgery, 12 weeks and 20 weeks after surgery

• Shoulder function - Shoulder Simple Test (SST)

  Before surgery, 12 weeks and 20 weeks after surgery

• Shoulder function - Constant Murley Shoulder Outcome Score

  Before surgery, 12 weeks and 20 weeks after surgery

• Pain - Visual Analog Scale (VAS)

  Before surgery, 12 weeks and 20 weeks after surgery

• Isokinetic Shoulder Mucle Strength

  Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery

Other Outcomes (2)

• Self-efficacy for exercise (SEE)

  Before surgery, 12 weeks and 20 weeks after surgery

• EQ-5D-5L, Quality of Life

  Before surgery, 12 weeks and 20 weeks after surgery

Study Arms (2)

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

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.

Other: control group (usual care)

Interventions

Intrevention group (mHealth group) 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

Intrevention group (mHealth group)

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.

control group (usual care)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Irwon-ro 81, 06351, South Korea

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 24, 2025
• Study Start: June 20, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)