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自宅では、逆肩の関節形成術の後の患者のデジタルリハビリテーション (DHI_RTSA)

2026年11月3日 更新者:JiHye Hwang、Samsung Medical Center

逆肩の逆肩関節形成術後の患者のモバイルアプリベースの自己再現の効果:パイロット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.

調査の概要

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Irwon-ro 81
      • Seoul、Irwon-ro 81、韓国、06351
        • Samsung Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

50年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Shoulder function - Korean shoulder score (KSS)
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Self-efficacy for exercise (SEE)
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年6月20日

一次修了 (推定)

2027年2月1日

研究の完了 (推定)

2027年3月30日

試験登録日

最初に提出

2025年3月14日

QC基準を満たした最初の提出物

2025年3月18日

最初の投稿 (実際)

2025年3月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月6日

QC基準を満たした最後の更新が送信されました

2026年11月3日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2025-02-088
  • RS-2024-00401350 (その他の助成金/資金番号:Korea Health Industry Development Institute)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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