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| ID | Type | Description | Link |
|---|---|---|---|
| RS-2024-00401350 | Other Grant/Funding Number | Korea Health Industry Development Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrevention group (mHealth group) | Experimental | The main characteristics of the intervention provided to the intervention group are as follows:
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| control group (usual care) | Active Comparator | This group performs home rehabilitation exercises using in-hospital educational materials. Control group data are retrospectively collected and matched using propensity score methods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrevention group (mHealth group) | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the American Shoulder and Elbow Surgeons (ASES) Score from Preoperative Baseline to 12 Weeks | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder function - Korean shoulder score (KSS) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy for exercise (SEE) |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Irwon-ro 81 | 06351 | South Korea |
Since this provides the subject's personal information to a third party, separate consent is required.
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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This non-randomized comparative study will prospectively recruit 30 participants to receive the intervention. Additionally, a retrospective cohort of approximately 70 patients will be selected using propensity score matching to serve as a control group.
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| control group (usual care) | Other | This group performs home rehabilitation exercises using in-hospital educational materials. Control group data are retrospectively collected and matched using propensity score methods. |
|
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 | 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) | 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 | 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) |
| Before surgery, 12 weeks and 20 weeks after surgery |
| Shoulder range of moiton - internal rotation | 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) |
| Before surgery, 12 weeks and 20 weeks after surgery |
| Isometric Shoulder Mucle Strength | 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 |
| Before surgery, 12 weeks and 20 weeks after surgery |
| EQ-5D-5L, Quality of Life | 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 |
| D008722 | Methods |