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Total Knee ArthroplastyNCT07505628

AI-based Rehabilitation for Hip and Knee Surgery Patients

A study testing Exersite Rehab (AI-based Mobile Application) and Printed Educational Brochure (Traditional Rehabilitation) in people with Total Knee Arthroplasty and Total Hip Arthroplasty (THA), run by Gangnam Severance Hospital at 2 sites in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Exersite Rehab (AI-based Mobile Application) and Printed Educational Brochure (Traditional Rehabilitation)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
2 sitesSouth Korea
Study dates
9 Mar 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jinyoung Park contact

+82-10-9383-6961

MDJYP@yuhs.ac

South Korea2 sites
  • Gangnam Severance Hospital

    Seoul, 06273

    Jinyoung Park, MD, PhD, +82-10-9383-6961, MDJYP@yuhs.ac

    Jinyoung Park, MD, PhD

  • Chung-Ang University Hospital

    Seoul, 06973

    Seong Hwan Kim, MD, PhD, +82-10-9919-6273, ksh170177@cau.ac.kr

Other trials in South Korea

About this study

Official title: 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.

Read the 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.
Being tested
Exersite Rehab (AI-based Mobile Application), Printed Educational Brochure (Traditional Rehabilitation)
Keywords
Arthroplasty, TKA, THA, Hip Fracture, Digital Therapeutics, AI Rehabilitation, Mobile Application, Home-based Exercise, Remote Monitoring, Physical Function
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exersite Rehab (AI-based Mobile Application)Device

    Also called AI-based Home Rehabilitation System, Digital Therapeutics for Orthopedic Recovery

    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.

  • Printed Educational Brochure (Traditional Rehabilitation)Behavioural

    Also called Standard Care, Conventional Rehabilitation, Brochure-based Exercise Group, Traditional Home-based Exercise

    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.

Study groups in NCT07505628
Study groupRoleWhat they receive
Experimental Group (AI App)ExperimentalParticipants 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.
Receives: Device: Exersite Rehab (AI-based Mobile Application)
Control Group (Brochure)Active comparatorParticipants in this group will perform the same 12-week rehabilitation exercise protocol using traditional printed educational brochures.
Receives: Behavioral: Printed Educational Brochure (Traditional Rehabilitation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: Baseline (Pre-operation) and POD 12 weeks

Secondary outcomes (16)
  1. Functional Ambulation Category (FAC)

    Functional ambulation status assessed on a scale of 0 (non-ambulatory) to 5 (independent).

    Measured: Baseline (Pre-op), POD 1 week, POD 4 weeks, POD 8 weeks, and POD 12 weeks

  2. Gait Analysis [Geometry]

    Evaluation of spatial parameters including Step length (Lt/Rt), Stride length, and Step width.

    • Unit of Measure: Centimeters (cm)

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  3. 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 (%)

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  4. 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

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  5. 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)

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  6. Range of Motion (ROM)

    Passive and active joint angles (flexion, extension, etc.) of the hip or knee measured by a goniometer.

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  7. 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).

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  8. Berg Balance Scale (BBS)

    A 14-item objective measure designed to assess static balance and fall risk. Total score ranges from 0 to 56.

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  9. 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

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  10. 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

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  11. 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

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  12. Pain (NRS(Numeric Rating Scale))

    Patient-reported pain intensity on a scale from 0 (no pain) to 10 (the most severe pain imaginable).

    Measured: Baseline (Pre-op), POD 1 week, POD 4 weeks, POD 8 weeks, and POD 12 weeks

  13. 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

    Measured: Baseline (Pre-op), POD 1 week, and POD 12 weeks

  14. 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)

    Measured: Baseline (Pre-op) and POD 12 weeks

  15. 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

    Measured: Baseline (Pre-op) and POD 12 weeks

  16. 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)

    Measured: Baseline (Pre-op) and POD 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start9 Mar 2026 (estimated)
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07505628
Sponsor's protocol ID
3-2025-0424
Status last verified
Mar 2026
First submitted
12 Mar 2026
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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.

    PubMed 17908573

Questions about this trial

What is this clinical trial studying?

A study testing Exersite Rehab (AI-based Mobile Application) and Printed Educational Brochure (Traditional Rehabilitation) in people with Total Knee Arthroplasty and Total Hip Arthroplasty (THA), run by Gangnam Severance Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jinyoung Park (+82-10-9383-6961, MDJYP@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed Up and Go (TUG) test (time frame: Baseline (Pre-operation) and POD 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07505628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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