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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorSamsung Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intrevention group (mHealth group)

    Other intervention

    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)

    Other intervention

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intrevention group (mHealth group)Experimental treatment 1 intervention
Group B: control group (usual care)Active comparator 1 intervention

Trial outcomes

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.

Time frame
Before surgery, 12 weeks and 20 weeks after surgery

Secondary outcomes

1

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).

Time frame
Before surgery, 12 weeks and 20 weeks after surgery
2

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.

Time frame
Before surgery, 12 weeks and 20 weeks after surgery
3

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.

Time frame
Before surgery, 12 weeks and 20 weeks after surgery
4

Pain - Visual Analog Scale (VAS)

The higher the Visual Analog Scale (VAS, 0\~10 points), the more pain there is.

Time frame
Before surgery, 12 weeks and 20 weeks after surgery

Other outcomes

1

Self-efficacy for exercise (SEE)

1. Consists of 9 items on situations that hinder exercise. 2. Evaluate how confident you are that you can exercise 20 minutes 3 times a week in each situation on a scale of 10% intervals from 0% (not at all confident) to 100% (very confident). 3. Interpret as '0-20% = not at all confident, 20-40% slightly confident, 40-60% = moderately confident, 60-80% = very confident, 80-100 = extremely confident.' * Collected only in prospective intervention group

Time frame
Before surgery, 12 weeks and 20 weeks after surgery
2

EQ-5D-5L, Quality of Life

The EQ-5D-5L is a standardized instrument developed by the EuroQol Group to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels. Index scores range from less than 0 (worse than death) to 1 (full health). This measure will be collected only in the prospective intervention group to evaluate changes in perceived quality of life during the rehabilitation process. Retrospective control data are not available for this outcome.

Time frame
Before surgery, 12 weeks and 20 weeks after surgery

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