Clinical trial NCT06891378: At Home, Digital Rehabilitation for Patients After Reverse Total Shoulder Arthroplasty
Official title: Effects of Mobile App-based Self-rehabilitation for Patients After Reverse Total Shoulder Arthroplasty: Pilot Non-RCT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arthroplasty, Replacement, Shoulder
Reverse Total Shoulder Arthroplasty
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
Secondary outcomes:
measure: Shoulder function - Korean shoulder score (KSS)
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
measure: Shoulder function - Shoulder Simple Test (SST)
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
measure: Shoulder function - Constant Murley Shoulder Outcome Score
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
measure: Pain - Visual Analog Scale (VAS)
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
measure: Isokinetic Shoulder Mucle Strength
timeFrame: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
measure: Active Shoulder range of moiton (degree)
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
measure: Shoulder range of moiton - internal rotation
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
measure: Passive Shoulder range of moiton (degree)
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
measure: Isometric Shoulder Mucle Strength
timeFrame: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
Other outcomes:
measure: Self-efficacy for exercise (SEE)
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
measure: EQ-5D-5L, Quality of Life
timeFrame: Before surgery, 12 weeks and 20 weeks after surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Irwon-ro 81
Study officials:
References: