AI-based Rehabilitation for Hip and Knee Surgery Patients

Evaluation of the Efficacy and Safety of AI-based Rehabilitation Exercise After Hip and Knee Arthroplasty

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Knee Arthroplasty; Hip Fracture Surgery; Total Hip Arthroplasty (THA)
• Intervention / Treatment: Device: Exersite Rehab (AI-based Mobile Application); Behavioral: Printed Educational Brochure (Traditional Rehabilitation)

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.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinyoung Park; Phone Number: +82-10-9383-6961; Email: MDJYP@yuhs.ac

Study Locations

• South Korea
  • Seoul, South Korea, 06273
    • Gangnam Severance Hospital
    • Contact: Jinyoung Park, MD, PhD; Phone Number: +82-10-9383-6961; Email: MDJYP@yuhs.ac
    • Principal Investigator: Jinyoung Park, MD, PhD
    • Sub-Investigator: Jung Hyun Park, MD,PhD
  • Seoul, South Korea, 06973
    • Chung-Ang University Hospital
    • Contact: Seong Hwan Kim, MD, PhD; Phone Number: +82-10-9919-6273; Email: ksh170177@cau.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group (AI App); 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.	Device: Exersite 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.; Other Names: AI-based Home Rehabilitation System, Digital Therapeutics for Orthopedic Recovery
Active Comparator: Control Group (Brochure); Participants in this group will perform the same 12-week rehabilitation exercise protocol using traditional printed educational brochures.	Behavioral: Printed 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.; Other Names: Standard Care, Conventional Rehabilitation, Brochure-based Exercise Group, Traditional Home-based Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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]	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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Collaborators: National IT Industry Promotion Agency, Republic of Korea

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 9, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Arthroplasty; Hip Fracture; Physical Function; Mobile Application; THA; Remote Monitoring; Digital Therapeutics; TKA; Home-based Exercise; AI Rehabilitation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 3-2025-0424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No