Knee OsteoarthritisNCT07774195
Efficacy of AI-Driven and Traditional Physical Therapy Programs in Patients With Knee Osteoarthritis
A study testing AI-Guided Physical Therapy Program, Traditional Physical Therapy Program and Lifestyle Modification and Joint Protection Education in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- AI-Guided Physical Therapy Program, Traditional Physical Therapy Program and Lifestyle Modification and Joint Protection Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Aug 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rania Reda Mohamed, PhD contact
Egypt1 site
Faculty of physical therapy, Cairo University
Giza
Marina Hosny Raghep, B.Sc, +20 12 71739917, Marinahosny2895@gmail.com
Rania Reda Mohamed, PhD
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- AI-Guided Physical Therapy Program, Traditional Physical Therapy Program, Lifestyle Modification and Joint Protection Education
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Guided Physical Therapy ProgramOther
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 ProgramOther
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 EducationBehavioural
Participants in both study arms will receive education on lifestyle modification and joint protection strategies as part of the management of knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional Physical Therapy Program; Behavioral: Lifestyle Modification and Joint Protection Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
Knee Range of Motion
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.
Measured: 12 weeks
Knee Pain, Stiffness, and Physical Function
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.
Measured: 12 weeks
Functional Mobility and Fall Risk
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start21 Aug 2026 (estimated)
- Primary completion21 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Hosny Raghep, Cairo University
- Investigators
- Mohsen El Sayyed, PhD, Study chair, Professor, Cairo UniversityRania Reda Mohamed, PhD, Study director, Assistant Professor, Cairo UniversityAli Al- Zawahri, PhD, Study director, Professor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774195
- Sponsor's protocol ID
- P.T.REC/012/006355
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of AI-Driven and Traditional Physical Therapy Programs in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07774195
- Acronym / sponsor ID
- P.T.REC/012/006355
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Aug 2026 (estimated)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Guided Physical Therapy Program + Lifestyle modification and joint protection strategies | Experimental | Other: AI-Guided Physical Therapy Program, Behavioral: Lifestyle Modification and Joint Protection EducationParticipants 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. |
| Traditional Physical Therapy Program + Lifestyle modification and joint protection strategies | Active comparator | Other: Traditional Physical Therapy Program, Behavioral: Lifestyle Modification and Joint Protection EducationParticipants 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Guided Physical Therapy ProgramParticipants 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. | Other | AI-Guided Physical Therapy Program + Lifestyle modification and joint protection strategies |
| Traditional Physical Therapy ProgramParticipants 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. | Other | Traditional Physical Therapy Program + Lifestyle modification and joint protection strategies |
| Lifestyle Modification and Joint Protection EducationParticipants in both study arms will receive education on lifestyle modification and joint protection strategies as part of the management of knee osteoarthritis. | Behavioural | AI-Guided Physical Therapy Program + Lifestyle modification and joint protection strategies, Traditional Physical Therapy Program + Lifestyle modification and joint protection strategies |
Primary outcome
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.
3 secondary outcomes
Knee Range of Motion
Time frame: 12 weeks
Knee Pain, Stiffness, and Physical Function
Time frame: 12 weeks
Functional Mobility and Fall Risk
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rania Reda Mohamed, PhD contact
Mohsen El Sayyed, PhD study chair
Professor, Cairo University
Rania Reda Mohamed, PhD study director
Assistant Professor, Cairo University
Ali Al- Zawahri, PhD study director
Professor, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Guided Physical Therapy Program, Traditional Physical Therapy Program and Lifestyle Modification and Joint Protection Education in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina Hosny Raghep, B.Sc (+20 12 71739917, Marinahosny2895@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.