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W domu, cyfrowa rehabilitacja dla pacjentów po odwróconej całkowitej alloplastyce barku (DHI_RTSA)

3 listopada 2026 zaktualizowane przez: JiHye Hwang, Samsung Medical Center

Wpływ samorehabilitacji opartej na aplikacjach mobilnych u pacjentów po odwróconej całkowitej alloplastyce barku: pilotażowy 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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Korea Południowa
    • Irwon-ro 81
      • Seoul, Irwon-ro 81, Korea Południowa, 06351
        • Samsung Medical Center

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Inny: 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
Aktywny komparator: 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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Shoulder function - Korean shoulder score (KSS)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Self-efficacy for exercise (SEE)
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Samsung Medical Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 czerwca 2025

Zakończenie podstawowe (Szacowany)

1 lutego 2027

Ukończenie studiów (Szacowany)

30 marca 2027

Daty rejestracji na studia

Pierwszy przesłany

14 marca 2025

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 marca 2025

Pierwszy wysłany (Rzeczywisty)

24 marca 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 listopada 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025-02-088
  • RS-2024-00401350 (Inny numer grantu/finansowania: Korea Health Industry Development Institute)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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