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

Effects of Mobile App-based Self-rehabilitation for Patients After Reverse Total Shoulder Arthroplasty: Pilot Non-RCT

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty, Replacement, Shoulder; Reverse Total Shoulder Arthroplasty
• Intervention / Treatment: Other: Intrevention group (mHealth group); Other: control group (usual care)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Irwon-ro 81
    • Seoul, Irwon-ro 81, Korea, Republic of, 06351
      • Recruiting
      • Samsung Medical Center
      • Contact: Lim; Phone Number: 82+10-8388-4465; Email: deartojay@skku.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrevention group (mHealth group); The main characteristics of the intervention provided to the intervention group are as follows: Customized rehabilitation exercise program is assigned after surgery and rehabilitation exercise is performed while watching the video; Recovery of shoulder joint range of motion can be checked through movement evaluation; Exercise diary writing (exercise schedule and post-exercise condition can be checked); Activity amount can be checked through step count collection; Exercise record is checked and, if exercise is not performed, reason is confirmed through contact	Other: Intrevention group (mHealth group); Receive a customized rehabilitation exercise program after surgery and perform rehabilitation exercises while watching videos; Check recovery of shoulder joint range of motion; Write an exercise diary (check exercise schedule and post-exercise condition); Check activity level through step count collection; Check exercise records and contact to confirm reason if exercise was not performed
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Before surgery, 12 weeks and 20 weeks after surgery
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.	Before surgery, 12 weeks and 20 weeks after surgery
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.	Before surgery, 12 weeks and 20 weeks after surgery
Pain - Visual Analog Scale (VAS)	The higher the Visual Analog Scale (VAS, 0~10 points), the more pain there is.	Before surgery, 12 weeks and 20 weeks after surgery
Isokinetic Shoulder Mucle Strength	Isokinetic strength: Using an isokinetic strength measuring device called CSMi Medical Solutions, isokinetic strength (internal rotation, external rotation) for each movement is measured according to a standardized protocol. During the test, the subject is seated on a chair and the torso is fixed to the dynamometer. The subject is asked to hold the opposite handle of the dynamometer.	Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
Active Shoulder range of moiton (degree)	Flexion: Measure the maximum angle when the arm is raised forward according to the standard protocol.; Abduction: Measure the maximum angle when the arm is raised sideways according to the standard protocol.; External rotation: Collect the maximum angle measured when the arm is placed next to the trunk.	Before surgery, 12 weeks and 20 weeks after surgery
Shoulder range of moiton - internal rotation	Internal rotation: Measure the position of the thumb tip on the spine level when the arm is sent behind the back. Each position is scored. (Thoracic T1-T12 = 1-12 points; Lumbar L1-L5 = 13-17 points; Hip = 18 points)	Before surgery, 12 weeks and 20 weeks after surgery
Passive Shoulder range of moiton (degree)	Flexion: Measure the maximum angle when the arm is raised forward according to the standard protocol.; Abduction: Measure the maximum angle when the arm is raised sideways according to the standard protocol.; External rotation: Collect the maximum angle measured when the arm is placed next to the trunk.	Before surgery, 12 weeks and 20 weeks after surgery
Isometric Shoulder Mucle Strength	Using a hand-held dynamometer (FGN-20B, SHIMPO, JAPAN), the maximum force (in pounds) is collected and measured in the internal rotation (at side), external rotation (at side), and scaption positions.	Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy for exercise (SEE)	Consists of 9 items on situations that hinder exercise.; 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).; 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	Before surgery, 12 weeks and 20 weeks after surgery
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.	Before surgery, 12 weeks and 20 weeks after surgery

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 14, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025-02-088; RS-2024-00401350 (Other Grant/Funding Number: Korea Health Industry Development Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since this provides the subject's personal information to a third party, separate consent is required.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No