AI-based Rehabilitation for Hip and Knee Surgery Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorGangnam Severance Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Experimental Group (AI App)Experimental treatment 1 intervention
Group B: Control Group (Brochure)Active comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gangnam Severance Hospital

Lead sponsor

National IT Industry Promotion Agency, Republic of Korea

Collaborator

This trial is not recruiting at the moment. You can still explore other options: