NCT07505628

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Dec 2028

Study Start

First participant enrolled

March 9, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

March 12, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

ArthroplastyTKATHAHip FractureDigital TherapeuticsAI RehabilitationMobile ApplicationHome-based ExerciseRemote MonitoringPhysical Function

Outcome Measures

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.)

    Baseline (Pre-operation) and POD 12 weeks

Secondary Outcomes (16)

  • Functional Ambulation Category (FAC)

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

  • Gait Analysis [Geometry]

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

  • Gait Analysis [Phase]

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

  • Gait Analysis [Timing (Cadence)]

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

  • Gait Analysis [Timing (Velocity)]

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

  • +11 more secondary outcomes

Study Arms (2)

Experimental Group (AI App)

EXPERIMENTAL

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)

Control Group (Brochure)

ACTIVE COMPARATOR

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

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
Experimental Group (AI App)

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
Control Group (Brochure)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 17908573BACKGROUND

Related Links

MeSH Terms

Conditions

Hip Fractures

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Central Study Contacts

Jinyoung Park

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor, Department of Rehabilitation Medicine

Study Record Dates

First Submitted

March 12, 2026

First Posted

April 1, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations