Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06891378

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, Irwon-ro 81, 06351, South Korea

Location status: Recruiting

Location contact

Lim

CONTACT

[email protected]

82+10-8388-4465

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrevention group (mHealth group)

Other
  • 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

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.

Primary outcomes

  1. Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks

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

    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.

Secondary outcomes

  1. Shoulder function - Korean shoulder score (KSS)

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

    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).

  2. Shoulder function - Shoulder Simple Test (SST)

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

    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.

  3. Shoulder function - Constant Murley Shoulder Outcome Score

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

    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.

  4. Pain - Visual Analog Scale (VAS)

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

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

  5. Isokinetic Shoulder Mucle Strength

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

    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.

  6. Active Shoulder range of moiton (degree)

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

    • 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.
  7. Shoulder range of moiton - internal rotation

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

    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)

  8. Passive Shoulder range of moiton (degree)

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

    • 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.
  9. Isometric Shoulder Mucle Strength

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

    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.

Other outcomes

  1. Self-efficacy for exercise (SEE)

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

    • 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
  2. EQ-5D-5L, Quality of Life

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

    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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: DHI_RTSA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.