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临床试验/NCT06891378
NCT06891378招募中不适用

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

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks

研究概览

简要总结

  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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Intrevention group (mHealth group)

Experimental

The main characteristics of the intervention provided to the intervention group are as follows:

  1. Customized rehabilitation exercise program is assigned after surgery and rehabilitation exercise is performed while watching the video
  2. Recovery of shoulder joint range of motion can be checked through movement evaluation
  3. Exercise diary writing (exercise schedule and post-exercise condition can be checked)
  4. Activity amount can be checked through step count collection
  5. Exercise record is checked and, if exercise is not performed, reason is confirmed through contact

干预措施: Intrevention group (mHealth group) (Other)

control group (usual care)

Active Comparator

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

干预措施: control group (usual care) (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JiHye Hwang

Professor

Samsung Medical Center

研究点 (1)

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