Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07774195

Efficacy of AI-Driven and Traditional Physical Therapy Programs in Patients With Knee Osteoarthritis

This study aims to compare the effectiveness of an artificial intelligence (AI)-guided physical therapy program with a traditional physical therapy program in patients with knee osteoarthritis.

Forty patients with knee osteoarthritis will be randomly assigned to one of two groups. The traditional physical therapy group will receive a conventional rehabilitation program including transcutaneous electrical nerve stimulation (TENS), strengthening, flexibility, and balance exercises. The AI-guided group will receive an individualized rehabilitation program generated using ChatGPT-4 based on standardized patient information and clinical assessment findings.

Both groups will receive education regarding lifestyle modification and joint protection strategies. The effects of the two rehabilitation approaches will be evaluated by measuring pain intensity, knee range of motion, knee-related functional ability, and functional mobility and fall risk before and after the intervention.

The study will determine whether an AI-guided physical therapy program can provide outcomes comparable or superior to those of traditional physical therapy in individuals with knee osteoarthritis.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of physical therapy, Cairo University

Giza, Egypt

Location contact

Marina Hosny Raghep, B.Sc

CONTACT

[email protected]

+20 12 71739917

Rania Reda Mohamed, PhD

CONTACT

About this study

This study is a prospective, single-blind, randomized controlled trial designed to compare the efficacy of an AI-guided physical therapy program with a traditional physical therapy program in patients with knee osteoarthritis.

A total of 40 patients with knee osteoarthritis will be recruited from the Outpatient Clinic of the Faculty of Physical Therapy, Cairo University. Eligible participants will be aged 45-70 years and diagnosed with knee osteoarthritis according to the American College of Rheumatology criteria, with Kellgren-Lawrence grade II or III osteoarthritis. Participants will be randomly allocated into two equal groups.

The control group will receive a conventional physical therapy program consisting of transcutaneous electrical nerve stimulation (TENS), strengthening exercises, flexibility exercises, and balance exercises. Treatment will be provided three times per week for 12 weeks.

The AI-guided group will receive an individualized rehabilitation program generated using ChatGPT-4. Standardized patient information, including age, sex, pain intensity, functional disability, knee range of motion, symptom duration, and physical activity level, will be entered by the researcher to generate an evidence-based rehabilitation program for each participant.

Both groups will also receive education regarding lifestyle modification and joint protection strategies.

Outcome measures will be assessed before and after the intervention. Pain intensity will be evaluated using the Visual Analog Scale (VAS), knee range of motion using a digital goniometer, knee-related pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and functional mobility and fall risk using the Timed Up and Go (TUG) test.

The study will compare changes in these outcomes between the two groups to determine the relative efficacy of AI-guided and traditional physical therapy programs for patients with knee osteoarthritis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants will be recruited through outpatient orthopedic clinics and community health centers affiliated with the study sites.
  • Their age will be ranged from 45-70 years.
  • Their body mass index (BMI) will be ranged from 24.9 to 30 kg /m2 .
  • With a clinical and radiographic diagnosis of knee osteoarthritis based on American College of Rheumatology criteria, with Kellgren-Lawrence grade II or III osteoarthritis, and who will able to ambulate
  • Independently walk without assistive devices.

Exclusion criteria

  • Prior knee replacement surgery, inflammatory arthritis (e.g., rheumatoid arthritis).
  • Recent intra-articular steroid injections within three months.
  • Neurologic impairments affecting lower limb function.
  • Inability to comprehend or use the mobile application due to cognitive or sensory impairments.

Treatment and study plan

AI-Guided Physical Therapy Program

Other

Participants will receive an individualized physical therapy program generated using ChatGPT-4. The researcher will manually enter standardized patient data, including age, sex, pain intensity (VAS), functional disability (WOMAC), knee range of motion, symptom duration, and physical activity level. ChatGPT-4 will be prompted to generate an evidence-based, in-clinic rehabilitation program for adults with knee osteoarthritis.

Traditional physical therapy program

Other

Participants will receive a traditional physical therapy program including transcutaneous electrical nerve stimulation (TENS), strengthening exercises, flexibility exercises, and balance exercises. The intervention will be administered three sessions per week for 12 weeks.

Lifestyle Modification and Joint Protection Education

Behavioral

Participants in both study arms will receive education on lifestyle modification and joint protection strategies as part of the management of knee osteoarthritis.

Primary outcomes

  1. Pain Intensity

    Time frame: 12 weeks

    Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst pain imaginable). Lower scores indicate less pain.

Secondary outcomes

  1. Knee Range of Motion

    Time frame: 12 weeks

    Active knee range of motion will be measured in degrees using a digital goniometer. Knee flexion and extension will be assessed before and after the intervention.

  2. Knee Pain, Stiffness, and Physical Function

    Time frame: 12 weeks

    Knee-related pain, stiffness, and physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The questionnaire includes 24 items covering pain, stiffness, and physical function. Higher scores indicate greater symptom severity and functional limitation.

  3. Functional Mobility and Fall Risk

    Time frame: 12 weeks

    Functional mobility and fall risk will be assessed using the Timed Up and Go (TUG) test. Participants will stand from a chair, walk 3 meters, turn, return to the chair, and sit down. The time required to complete the task will be recorded in seconds; longer times indicate poorer functional mobility and greater fall risk.

Study contacts

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

Marina Hosny Raghep, B.Sc

CONTACT

[email protected]

+20 12 71739917

Rania Reda Mohamed, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 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.

Published trials that share one or more normalized conditions with this study.