Hip Fracture Surgery, Total Hip Arthroplasty (THA), Total Knee Arthroplasty
Conditions
Keywords
Arthroplasty, TKA, THA, Hip Fracture, Digital Therapeutics, AI Rehabilitation, Mobile Application, Home-based Exercise, Remote Monitoring, Physical Function
Brief summary
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.
Detailed description
* Study Overview and Randomization This study is conducted as a multi-center, randomized, open-label trial. After providing informed consent and completing baseline assessments, eligible participants are randomly assigned to either the Experimental Group or the Control Group at a 1:1 ratio. The primary focus is to evaluate the recovery of physical mobility through different home-based rehabilitation methods. * Technical Intervention Protocols The Experimental Group utilizes the "Exercite Rehab" mobile application, which incorporates AI-based computer vision technology. The application recognizes the participant's joint movements in real-time through the device's camera, providing immediate corrective feedback on exercise posture and automatically logging the completion of prescribed routines. In contrast, the Control Group follows the same clinical exercise protocol using traditional printed educational materials. Participants in this group manually record their daily exercise performance in a provided physical logbook. * Longitudinal Monitoring and Follow-up Following the initial in-hospital education session, participants transition to a 12-week home-based phase. Research personnel conduct remote monitoring at specific intervals (Weeks 4 and 8) to ensure safety, assess exercise adherence, and track symptomatic changes via telephone or the application's monitoring dashboard. A final face-to-face clinical evaluation is performed at Week 12 to determine the overall efficacy of the intervention compared to the conventional method.
Interventions
DEVICEExersite Rehab (AI-based Mobile Application)
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.
BEHAVIORALPrinted Educational Brochure (Traditional Rehabilitation)
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.
Sponsors
Gangnam Severance Hospital
National IT Industry Promotion Agency, Republic of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 19 years or older. * Patients scheduled to undergo hip or knee arthroplasty at Gangnam Severance Hospital or affiliated hospitals of Chung-Ang University Medical Center (Chung-Ang University Hospital, Gwangmyeong Hospital, Hyundai Hospital). * Patients with a preoperative Functional Ambulatory Category (FAC) stage of 4 or 5 (For hip fracture cases, pre-fracture FAC stage will be considered). * Patients capable of downloading and using mobile applications on smart devices (smartphones or tablets) independently without researcher assistance. * Patients who fully understand the study's purpose and procedures and have voluntarily signed the informed consent form.
Exclusion criteria
* Individuals unable to perform exercises due to severe musculoskeletal pain. * Individuals with severe dizziness or poor vision that prevents them from following exercise videos provided by the digital treatment. * Individuals with visual impairment that causes difficulty in recognizing the monitor/device screen. * Individuals requiring long-term inpatient treatment due to unstable vital signs. * Individuals with partial or total lower-limb amputation due to trauma, disease, or congenital defects. * Individuals classified as vulnerable subjects (as defined by clinical research ethics guidelines). * Any other individuals deemed ineligible for participation at the discretion of the principal investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) test | Baseline (Pre-operation) and POD 12 weeks | 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.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Ambulation Category (FAC) | Baseline (Pre-op), POD 1 week, POD 4 weeks, POD 8 weeks, and POD 12 weeks | Functional ambulation status assessed on a scale of 0 (non-ambulatory) to 5 (independent). |
| Gait Analysis [Geometry] | Baseline (Pre-op), POD 1 week, and POD 12 weeks | Evaluation of spatial parameters including Step length (Lt/Rt), Stride length, and Step width. • Unit of Measure: Centimeters (cm) |
| Gait Analysis [Phase] | Baseline (Pre-op), POD 1 week, and POD 12 weeks | Assessment of the percentage distribution of gait phases: Stance phase (Lt/Rt), Swing phase (Lt/Rt), and Double stance phase. • Unit of Measure: Percentage (%) |
| Gait Analysis [Timing (Cadence)] | Baseline (Pre-op), POD 1 week, and POD 12 weeks | 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 |
| Gait Analysis [Timing (Velocity)] | Baseline (Pre-op), POD 1 week, and POD 12 weeks | 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) |
| Range of Motion (ROM) | Baseline (Pre-op), POD 1 week, and POD 12 weeks | Passive and active joint angles (flexion, extension, etc.) of the hip or knee measured by a goniometer. |
| Manual Muscle Test (MMT) | Baseline (Pre-op), POD 1 week, and POD 12 weeks | Assessment of muscle strength around the hip or knee joint using a scale from 0 (no muscle contraction) to 5 (normal strength). |
| Berg Balance Scale (BBS) | Baseline (Pre-op), POD 1 week, and POD 12 weeks | A 14-item objective measure designed to assess static balance and fall risk. Total score ranges from 0 to 56. |
| Physical Function (Harris Hip Score [HHS]) | Baseline (Pre-op), POD 1 week, and POD 12 weeks | 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 |
| Physical Function (Knee Society Score [KSS]) | Baseline (Pre-op), POD 1 week, and POD 12 weeks | : 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 |
| Physical Function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) | Baseline (Pre-op), POD 1 week, and POD 12 weeks | 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 |
| Pain (NRS(Numeric Rating Scale)) | Baseline (Pre-op), POD 1 week, POD 4 weeks, POD 8 weeks, and POD 12 weeks | Patient-reported pain intensity on a scale from 0 (no pain) to 10 (the most severe pain imaginable). |
| Quality of Life (Short Form-36 [SF-36]) | Baseline (Pre-op), POD 1 week, and POD 12 weeks | 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 |
| Muscle Strength (Handgrip Strength) | Baseline (Pre-op) and POD 12 weeks | Assessment of maximum voluntary contraction using a digital hand dynamometer. Higher values indicate better muscle strength. • Unit of Measure: Kilograms (kg) |
| Physical Performance (Short Physical Performance Battery [SPPB]) | Baseline (Pre-op) and POD 12 weeks | 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 |
| Body Composition (Bioelectrical Impedance Analysis [BIA]) | Baseline (Pre-op) and POD 12 weeks | 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) |
Countries
South Korea
Contacts
CONTACTJinyoung Park
Outcome results
None listed