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| Name | Class |
|---|---|
| National IT Industry Promotion Agency, South Korea | OTHER |
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This study aims to evaluate the efficacy and safety of an AI-based home rehabilitation application ("Exersite Rehab") for patients who have undergone hip or knee arthroplasty(Total Knee Arthroplasty (TKA), Total Hip Arthroplasty (THA) or hip fracture surgery). Following surgery, effective rehabilitation is crucial for functional recovery; however, many patients face barriers to consistent in-hospital exercise. This interventional study divides participants into two groups to compare outcomes. The experimental group will perform a 12-week home-based rehabilitation program guided by an AI application that provides real-time posture correction and monitoring. In contrast, the control group will perform the same exercise protocol using traditional printed educational brochures.The primary objective is to determine if the AI-based digital healthcare solution significantly improves physical function, measured by the Functional Ambulatory Category(FAC), compared to conventional methods. Secondary outcomes including pain levels(Visual Analog Scale (VAS)) and joint-specific functional scores (Knee Society Score (KSS), Harris Hip Score (HHS)) will also be assessed over the 12-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (AI App) | Experimental | Participants in this group will perform a 12-week home rehabilitation program using the "Exercite Rehab" AI-based mobile application, which provides real-time motion tracking and feedback. |
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| Control Group (Brochure) | Active Comparator | Participants in this group will perform the same 12-week rehabilitation exercise protocol using traditional printed educational brochures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exersite Rehab (AI-based Mobile Application) | Device | The "Exersite Rehab" is an AI-driven digital healthcare solution designed for post-operative rehabilitation. It utilizes computer vision technology to track the patient's skeletal movements in real-time through a smartphone camera. During the 12-week program, the device provides personalized exercise protocols, real-time posture correction, and automatic repetition counting to ensure safe and effective home-based rehabilitation for patients after hip or knee surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go (TUG) test | The TUG test measures the time (in seconds) taken by a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. It is used to assess mobility, balance, and fall risk. (Note: For hip fracture patients, the baseline is measured at POD 1 week instead of pre-op.) | Baseline (Pre-operation) and POD 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Ambulation Category (FAC) | Functional ambulation status assessed on a scale of 0 (non-ambulatory) to 5 (independent). | Baseline (Pre-op), POD 1 week, POD 4 weeks, POD 8 weeks, and POD 12 weeks |
| Gait Analysis [Geometry] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinyoung Park | Contact | +82-10-9383-6961 | MDJYP@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17908573 | Background | Verheyden G, Willems AM, Ooms L, Nieuwboer A. Validity of the trunk impairment scale as a measure of trunk performance in people with Parkinson's disease. Arch Phys Med Rehabil. 2007 Oct;88(10):1304-8. doi: 10.1016/j.apmr.2007.06.772. |
| Label | URL |
|---|---|
| Healthcare Bigdata Hub by Health Insurance Review \& Assessment Service (HIRA): Used for analyzing medical statistics and healthcare trends related to orthopedic surgery in South Korea. | View source |
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Individual participant data (IPD) will not be shared with other researchers to ensure the privacy and confidentiality of the participants, in accordance with the Institutional Review Board (IRB) guidelines and personal information protection protocols of Gangnam Severance Hospital. Only de-identified, aggregated study results and statistical analyses will be made available through scientific publications and conference presentations. Access to the raw data is restricted to the primary investigators and authorized research personnel involved in the "Dr. Answer 3.0" project.
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Participants will be randomly assigned to either the experimental group or the control group in a 1:1 ratio. The experimental group will perform a 12-week home rehabilitation program using an AI-based mobile application, while the control group will follow the same exercise protocol using traditional printed educational brochures.
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This is an open-label study where masking of participants and care providers is not feasible due to the nature of the interventions (AI-based mobile application vs. printed educational brochure). Both groups will be clearly aware of the assigned rehabilitation method. However, to minimize bias, the statistical analysis will be conducted using de-identified data.
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| Printed Educational Brochure (Traditional Rehabilitation) | Behavioral | Participants in the control group will receive traditional printed educational brochures containing standardized post-operative exercise protocols for hip or knee surgery. These brochures include step-by-step illustrations and written instructions for home-based rehabilitation exercises. Participants are instructed to perform the prescribed exercises independently for 12 weeks, following the same schedule and frequency as the experimental group, but without the AI-based real-time feedback or digital monitoring. |
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Evaluation of spatial parameters including Step length (Lt/Rt), Stride length, and Step width.
• Unit of Measure: Centimeters (cm)
| Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Gait Analysis [Phase] | Assessment of the percentage distribution of gait phases: Stance phase (Lt/Rt), Swing phase (Lt/Rt), and Double stance phase. • Unit of Measure: Percentage (%) | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Gait Analysis [Timing (Cadence)] | Evaluation of temporal gait parameters focusing on cadence. It measures the number of steps taken per minute (steps/min) using a gait analysis system. • Unit of Measure: Steps per minute | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Gait Analysis [Timing (Velocity)] | Evaluation of temporal gait parameters focusing on velocity. It measures the participant's walking speed (km/h) using a gait analysis system. • Unit of Measure: Kilometers per hour (km/h) | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Range of Motion (ROM) | Passive and active joint angles (flexion, extension, etc.) of the hip or knee measured by a goniometer. | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Manual Muscle Test (MMT) | Assessment of muscle strength around the hip or knee joint using a scale from 0 (no muscle contraction) to 5 (normal strength). | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Berg Balance Scale (BBS) | A 14-item objective measure designed to assess static balance and fall risk. Total score ranges from 0 to 56. | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Physical Function (Harris Hip Score [HHS]) | A clinician-based assessment used to evaluate hip function. The score ranges from 0 to 100, where higher scores indicate better functional outcomes and less pain. • Unit of Measure: Units on a scale | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Physical Function (Knee Society Score [KSS]) | : A clinician-based assessment used to evaluate knee function and patient satisfaction. The score ranges from 0 to 100, where higher scores indicate better clinical outcomes and improved knee function. • Unit of Measure: Units on a scale | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Physical Function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) | A self-reported questionnaire used to evaluate the condition of patients with osteoarthritis. The score ranges from 0 to 96, where lower scores indicate better outcomes (less pain, stiffness, and physical limitation). • Unit of Measure: Units on a scale | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Pain (NRS(Numeric Rating Scale)) | Patient-reported pain intensity on a scale from 0 (no pain) to 10 (the most severe pain imaginable). | Baseline (Pre-op), POD 1 week, POD 4 weeks, POD 8 weeks, and POD 12 weeks |
| Quality of Life (Short Form-36 [SF-36]) | A self-reported questionnaire (Short Form-36 [SF-36]) used to evaluate health-related quality of life, covering both physical and mental health domains. The score for each domain ranges from 0 to 100, where higher scores indicate a better quality of life and better health status. • Unit of Measure: Units on a scale | Baseline (Pre-op), POD 1 week, and POD 12 weeks |
| Muscle Strength (Handgrip Strength) | Assessment of maximum voluntary contraction using a digital hand dynamometer. Higher values indicate better muscle strength. • Unit of Measure: Kilograms (kg) | Baseline (Pre-op) and POD 12 weeks |
| Physical Performance (Short Physical Performance Battery [SPPB]) | A standardized assessment including gait speed, chair stand test, and balance tests. The total score ranges from 0 to 12, where higher scores indicate better physical performance and mobility. • Unit of Measure: Units on a scale | Baseline (Pre-op) and POD 12 weeks |
| Body Composition (Bioelectrical Impedance Analysis [BIA]) | Evaluation of body composition, specifically focusing on skeletal muscle mass, using a Bioelectrical Impedance Analysis (BIA) device. This assessment measures the electrical impedance of body tissues to estimate muscle mass. Higher values indicate a greater amount of muscle mass. • Unit of Measure: Kilograms (kg) | Baseline (Pre-op) and POD 12 weeks |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
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| D007869 |
| Leg Injuries |