ClinicalTrials.gg
Not yet recruitingNCT07505628Updated Apr 1, 2026

AI-based Rehabilitation for Hip and Knee Surgery Patients

An interventional study of Exersite Rehab (AI-based Mobile Application) and Printed Educational Brochure (Traditional Rehabilitation) in Total Knee Arthroplasty, Total Hip Arthroplasty (THA) and Hip Fracture Surgery, sponsored by Gangnam Severance Hospital. Not yet recruiting at 2 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

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.
02

Conditions studied

  • Total Knee Arthroplasty
  • Total Hip Arthroplasty (THA)
  • Hip Fracture Surgery

Browse trials for

Keywords

  • Arthroplasty
  • TKA
  • THA
  • Hip Fracture
  • Digital Therapeutics
  • AI Rehabilitation
  • Mobile Application
  • Home-based Exercise
  • Remote Monitoring
  • Physical Function
03

In context

Hip Fractures

842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.

This study's planned enrollment of 106 is above the median of 86 across 533 interventional studies indexed under Hip Fractures.

Browse Hip Fractures studies →

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 146 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (estimated)

Study arms

  • 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)

  • 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)

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.

    Also known as: AI-based Home Rehabilitation System, Digital Therapeutics for Orthopedic Recovery

  • 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.

    Also known as: Standard Care, Conventional Rehabilitation, Brochure-based Exercise Group, Traditional Home-based Exercise

06

What researchers measure

Primary outcomes

  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.)

    Time frame: Baseline (Pre-operation) and POD 12 weeks

Secondary outcomes

  1. Functional Ambulation Category (FAC)

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

    Time frame: 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)

    Time frame: 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 (%)

    Time frame: 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

    Time frame: 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)

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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).

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: Baseline (Pre-op) and POD 12 weeks

07

Study locations

2 sites
08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07505628
Collaborators
National IT Industry Promotion Agency, South Korea
Responsible party
Jinyoung Park (Associate Clinical Professor, Department of Rehabilitation Medicine, Gangnam Severance Hospital) — Principal investigator
First posted
Apr 1, 2026
Start date
Mar 9, 2026 (estimated)
Primary completion
May 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 1, 2026

Study contacts

Jinyoung Park
Contact
MDJYP@yuhs.ac
+82-10-9383-6961

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion