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NCT Number: NCT07505628

AI-based Rehabilitation for Hip and Knee Surgery Patients

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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Key information

Conditions

Total Knee Arthroplasty Femoral Fractures Fractures, Bone Hip Fracture Surgery Hip Fractures Hip Injuries Leg Injuries Total Hip Arthroplasty (THA) Wounds and Injuries

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang University Hospital, Seoul, South Korea

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: AI-based Home Rehabilitation System, Digital Therapeutics for Orthopedic Recovery

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.

Other names: Standard Care, Conventional Rehabilitation, Brochure-based Exercise Group, Traditional Home-based Exercise

Primary outcomes

  1. Timed Up and Go (TUG) test

    Time frame: 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 outcomes

  1. Functional Ambulation Category (FAC)

    Time frame: 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).

  2. Gait Analysis [Geometry]

    Time frame: 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)

  3. Gait Analysis [Phase]

    Time frame: 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 (%)

  4. Gait Analysis [Timing (Cadence)]

    Time frame: 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

  5. Gait Analysis [Timing (Velocity)]

    Time frame: 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)

  6. Range of Motion (ROM)

    Time frame: 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.

  7. Manual Muscle Test (MMT)

    Time frame: 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).

  8. Berg Balance Scale (BBS)

    Time frame: 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.

  9. Physical Function (Harris Hip Score [HHS])

    Time frame: 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

  10. Physical Function (Knee Society Score [KSS])

    Time frame: 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

  11. Physical Function (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC])

    Time frame: 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

  12. Pain (NRS(Numeric Rating Scale))

    Time frame: 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).

  13. Quality of Life (Short Form-36 [SF-36])

    Time frame: 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

  14. Muscle Strength (Handgrip Strength)

    Time frame: 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)

  15. Physical Performance (Short Physical Performance Battery [SPPB])

    Time frame: 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

  16. Body Composition (Bioelectrical Impedance Analysis [BIA])

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jinyoung Park

CONTACT

[email protected]

+82-10-9383-6961

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Collaborators

  • National IT Industry Promotion Agency, South Korea

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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