- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06891378
En el hogar, rehabilitación digital para pacientes después de la artroplastia de hombro total inversa (DHI_RTSA)
Efectos de la auto-rehabilitación basada en aplicaciones móviles para pacientes después de la artroplastia total de hombro inverso: ECA 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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Irwon-ro 81
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Seoul, Irwon-ro 81, Corea del Sur, 06351
- Samsung Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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 activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Shoulder function - Korean shoulder score (KSS)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-efficacy for exercise (SEE)
Periodo de tiempo: 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
Periodo de tiempo: 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
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-02-088
- RS-2024-00401350 (Otro número de subvención/financiamiento: Korea Health Industry Development Institute)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Since this provides the subject's personal information to a third party, separate consent is required.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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