- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06891378
Em casa, reabilitação digital para pacientes após artroplastia total do ombro reverso (DHI_RTSA)
Efeitos da auto-reabilitação baseada em aplicativos móveis para pacientes após artroplastia total do ombro reverso: RCT piloto
- 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.
- 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.
- 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.
- 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.
- 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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Irwon-ro 81
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Seoul, Irwon-ro 81, Coréia do Sul, 06351
- Samsung Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intrevention group (mHealth group)
The main characteristics of the intervention provided to the intervention group are as follows:
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Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Shoulder function - Korean shoulder score (KSS)
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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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
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Shoulder function - Shoulder Simple Test (SST)
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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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
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Shoulder function - Constant Murley Shoulder Outcome Score
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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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
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Pain - Visual Analog Scale (VAS)
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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The higher the Visual Analog Scale (VAS, 0~10 points), the more pain there is. |
Before surgery, 12 weeks and 20 weeks after surgery
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Isokinetic Shoulder Mucle Strength
Prazo: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
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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
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Active Shoulder range of moiton (degree)
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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Before surgery, 12 weeks and 20 weeks after surgery
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Shoulder range of moiton - internal rotation
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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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
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Passive Shoulder range of moiton (degree)
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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Before surgery, 12 weeks and 20 weeks after surgery
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Isometric Shoulder Mucle Strength
Prazo: Before surgery, 12 weeks (only Isometric strength) and 20 weeks after surgery
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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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Self-efficacy for exercise (SEE)
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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Before surgery, 12 weeks and 20 weeks after surgery
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EQ-5D-5L, Quality of Life
Prazo: Before surgery, 12 weeks and 20 weeks after surgery
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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
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-02-088
- RS-2024-00401350 (Número de outro subsídio/financiamento: Korea Health Industry Development Institute)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Since this provides the subject's personal information to a third party, separate consent is required.
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