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

NCT07774195 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006355
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  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.

  12 weeks

Secondary Outcomes (3)

• Knee Range of Motion

  12 weeks

• Knee Pain, Stiffness, and Physical Function

  12 weeks

• Functional Mobility and Fall Risk

  12 weeks

Study Arms (2)

AI-Guided Physical Therapy Program + Lifestyle modification and joint protection strategies

EXPERIMENTAL

Participants in this arm will receive an individualized AI-guided 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 then generate an evidence-based, in-clinic rehabilitation program for knee osteoarthritis. Participants will also receive education on lifestyle modification and joint protection strategies.

Other: AI-Guided Physical Therapy Program; Behavioral: Lifestyle Modification and Joint Protection Education

Traditional Physical Therapy Program + Lifestyle modification and joint protection strategies

ACTIVE COMPARATOR

Participants in this arm will receive a conventional physical therapy program consisting of transcutaneous electrical nerve stimulation (TENS), strengthening exercises, flexibility exercises, and balance exercises. The program will be delivered three times per week for 12 weeks. Participants will also receive education on lifestyle modification and joint protection strategies.

Other: Traditional Physical Therapy Program; Behavioral: Lifestyle Modification and Joint Protection Education

Interventions

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.

AI-Guided Physical Therapy Program + Lifestyle modification and joint protection strategies

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.

Traditional Physical Therapy Program + Lifestyle modification and joint protection strategies

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.

AI-Guided Physical Therapy Program + Lifestyle modification and joint protection strategies; Traditional Physical Therapy Program + Lifestyle modification and joint protection strategies

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mohsen El Sayyed, PhD

  Professor, Cairo University

  STUDY CHAIR

• Rania Reda Mohamed, PhD

  Assistant Professor, Cairo University

  STUDY DIRECTOR

• Ali Al- Zawahri, PhD

  Professor, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Marina Hosny Raghep, B.Sc

CONTACT

+20 12 71739917; Marinahosny2895@gmail.com

Rania Reda Mohamed, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Locations

EG (1)