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집에서, 총 어깨 관절 성형술 후 환자를위한 디지털 재활 (DHI_RTSA)

2026년 11월 3일 업데이트: JiHye Hwang, Samsung Medical Center

역방향 총 어깨 관절 성형술 후 환자에 대한 모바일 앱 기반 자체 재활의 영향 : 파일럿 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.

연구 개요

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Irwon-ro 81
      • Seoul, Irwon-ro 81, 대한민국, 06351
        • Samsung Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Intrevention group (mHealth group)

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
  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
활성 비교기: 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.

This group performs home rehabilitation exercises using in-hospital educational materials.

Control group data are retrospectively collected and matched using propensity score methods.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks
기간: 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.

Before surgery, 12 weeks and 20 weeks after surgery

2차 결과 측정

결과 측정
측정값 설명
기간
Shoulder function - Korean shoulder score (KSS)
기간: 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).

Before surgery, 12 weeks and 20 weeks after surgery
Shoulder function - Shoulder Simple Test (SST)
기간: 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.

Before surgery, 12 weeks and 20 weeks after surgery
Shoulder function - Constant Murley Shoulder Outcome Score
기간: 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.

Before surgery, 12 weeks and 20 weeks after surgery
Pain - Visual Analog Scale (VAS)
기간: Before surgery, 12 weeks and 20 weeks after surgery

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
기간: 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.

Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
Active Shoulder range of moiton (degree)
기간: Before surgery, 12 weeks and 20 weeks after surgery
  1. Flexion: Measure the maximum angle when the arm is raised forward according to the standard protocol.
  2. Abduction: Measure the maximum angle when the arm is raised sideways according to the standard protocol.
  3. 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
기간: 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)

Before surgery, 12 weeks and 20 weeks after surgery
Passive Shoulder range of moiton (degree)
기간: Before surgery, 12 weeks and 20 weeks after surgery
  1. Flexion: Measure the maximum angle when the arm is raised forward according to the standard protocol.
  2. Abduction: Measure the maximum angle when the arm is raised sideways according to the standard protocol.
  3. 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
기간: 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.

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

기타 결과 측정

결과 측정
측정값 설명
기간
Self-efficacy for exercise (SEE)
기간: Before surgery, 12 weeks and 20 weeks after surgery
  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
Before surgery, 12 weeks and 20 weeks after surgery
EQ-5D-5L, Quality of Life
기간: 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.

Before surgery, 12 weeks and 20 weeks after surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 6월 20일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 3월 30일

연구 등록 날짜

최초 제출

2025년 3월 14일

QC 기준을 충족하는 최초 제출

2025년 3월 18일

처음 게시됨 (실제)

2025년 3월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 3일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2025-02-088
  • RS-2024-00401350 (기타 보조금/기금 번호: Korea Health Industry Development Institute)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Since this provides the subject's personal information to a third party, separate consent is required.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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