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

Overview

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.

Interventions

• Other Intrevention group (mHealth group)
  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
• 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.

Primary outcome measures

• 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]

Secondary outcome measures (9)

• Shoulder function - Korean shoulder score (KSS) [Time frame: Before surgery, 12 weeks and 20 weeks after surgery]
• Shoulder function - Shoulder Simple Test (SST) [Time frame: Before surgery, 12 weeks and 20 weeks after surgery]
• Shoulder function - Constant Murley Shoulder Outcome Score [Time frame: Before surgery, 12 weeks and 20 weeks after surgery]
• Pain - Visual Analog Scale (VAS) [Time frame: Before surgery, 12 weeks and 20 weeks after surgery]
• Isokinetic Shoulder Mucle Strength [Time frame: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery]
• Active Shoulder range of moiton (degree) [Time frame: Before surgery, 12 weeks and 20 weeks after surgery]
• Shoulder range of moiton - internal rotation [Time frame: Before surgery, 12 weeks and 20 weeks after surgery]
• Passive Shoulder range of moiton (degree) [Time frame: Before surgery, 12 weeks and 20 weeks after surgery]
• Isometric Shoulder Mucle Strength [Time frame: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

South Korea · 1 center

• Samsung Medical Center — Seoul

Identifiers

NCT: NCT06891378 · 2025-02-088 · RS-2024-00401350

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗