Knee OsteoarthritisNCT07066514
Effectiveness of AI-Supervised Mobile Exercise Application in Patients With Knee Osteoarthritis
A study testing AI-Supervised Mobile Exercise Program and Booklet-Guided Home Exercise Program in people with Knee Osteoarthritis, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of an artificial intelligence (AI)-supported mobile application that supervises home-based exercise programs in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- AI-Supervised Mobile Exercise Program and Booklet-Guided Home Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 40 and 80 years
- Diagnosed with knee osteoarthritis according to ACR criteria
- Referred to physical therapy by a physician for knee osteoarthritis
- Able to use a smartphone or tablet
- Having regular access to the internet
- Voluntarily agrees to participate in the study
Who cannot join
- History of knee surgery or currently undergoing surgical treatment
- Received physical therapy or rehabilitation for knee OA within the past 6 months
- Lack of access to a mobile device or internet
- Any neurological, cardiovascular, or musculoskeletal condition that prevents safe participation in exercise
- Cognitive impairment or psychiatric disorder interfering with exercise adherence
- Inability to follow instructions or use the mobile app interface
- Any condition that would contraindicate participation in a home-based exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Exercises Supervised Via an Artificial Intelligence-Supported Mobile Application in Patients With Knee Osteoarthritis
This study aims to evaluate the effectiveness of an artificial intelligence (AI)-supported mobile application that supervises home-based exercise programs in patients with knee osteoarthritis. A total of 80 participants aged 40 to 80 will be randomly assigned to one of two groups: a mobile application exercise group or a home exercise booklet group. Both groups will receive the same standardized stretching, strengthening, and range of motion exercises designed for knee osteoarthritis. The mobile app provides real-time feedback and supervision using the device's camera and artificial intelligence algorithms to track and guide exercise performance.
Participants in the app group will perform exercises with supervision via the app interface, while the control group will follow the same exercises using printed instructions. Both groups will exercise 3 to 4 times per week for 4 weeks. The study will compare pain levels, physical function, and balance before and after the intervention using validated outcome measures such as the WOMAC Index and the Visual Analog Scale.
This study may help determine whether AI-supported digital tools can improve exercise adherence and outcomes in patients with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- AI-Supervised Mobile Exercise Program, Booklet-Guided Home Exercise Program
- 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-Supervised Mobile Exercise ProgramBehavioural
This intervention involves the use of an artificial intelligence (AI)-supported mobile application that delivers a personalized exercise program to patients with knee osteoarthritis. The app supervises exercise execution in real time using the device's camera and AI algorithms to track movements, count repetitions, and assess form accuracy. The program includes stretching, strengthening, and range of motion exercises performed 3-4 times per week for 4 weeks. The app provides instructional videos, personalized feedback, reminders, and records user performance. No video or personal images are stored; only anonymized motion data are collected and securely stored.
Booklet-Guided Home Exercise ProgramBehavioural
This intervention provides patients with a standardized home exercise program in printed booklet format. The program includes the same evidence-based stretching, strengthening, and range of motion exercises used in the mobile application group, performed 3-4 times per week for 4 weeks. Participants receive one-time in-person instruction on proper form but no ongoing supervision or feedback during the program. Adherence and technique are self-monitored.
| Study group | Role | What they receive |
|---|---|---|
| AI-Based Mobile Home Exercise Group | Experimental | Not described Receives: Behavioral: AI-Supervised Mobile Exercise Program |
| Standard Home Exercise Group | Experimental | Not described Receives: Behavioral: Booklet-Guided Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC is a validated questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items: 5 for pain, 2 for stiffness, and 17 for physical function. Each item is scored on a 5-point Likert scale (0 = none to 4 = extreme), with a total score range of 0 to 96. Higher scores indicate worse symptoms.
Measured: Baseline and Week 4
Visual Analog Scale (VAS)
Change in pain severity measured by the Visual Analog Scale (VAS; range: 0-10; higher scores indicate worse pain) at baseline and at 6 weeks.
Measured: Baseline and Week 4
Timed Up and Go (TUG) Test
Measured: Baseline and Week 4
Functional Reach Test (FRT)
Measured: Baseline and Week 4
Single-Leg Stance Test
Measured: Baseline and Week 4
Exercise Execution Accuracy Assessed by Mobile Application
Accuracy of exercise adherence detection by the AI algorithm compared to physiotherapist assessment (% agreement)
Measured: Before and during the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: The study was stopped due to delays in the development and updating of the AI-assisted application intended for use in the study. As no further progress could be made at this stage, the study was withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selim Mahmut GÜNAY, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066514
- Sponsor's protocol ID
- 2025-2/19
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nelligan RK, Hinman RS, Kasza J, Crofts SJC, Bennell KL. Effects of a Self-directed Web-Based Strengthening Exercise and Physical Activity Program Supported by Automated Text Messages for People With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jun 1;181(6):776-785. doi: 10.1001/jamainternmed.2021.0991.
PubMed 33843948Xiang XN, Wang ZZ, Hu J, Zhang JY, Li K, Chen QX, Xu FS, Zhang YW, He HC, He CQ, Zhu SY. Telehealth-Supported Exercise or Physical Activity Programs for Knee Osteoarthritis: Systematic Review and Meta-Analysis. J Med Internet Res. 2024 Aug 2;26:e54876. doi: 10.2196/54876.
PubMed 39094114
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercises Supervised Via an Artificial Intelligence-Supported Mobile Application in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07066514
- Acronym / sponsor ID
- 2025-2/19
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was stopped due to delays in the development and updating of the AI-assisted application intended for use in the study. As no further progress could be made at this stage, the study was withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 15 Jul 2025 (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 evaluate the effectiveness of an artificial intelligence (AI)-supported mobile application that supervises home-based exercise programs in patients with knee osteoarthritis. A total of 80 participants aged 40 to 80 will be randomly assigned to one of two groups: a mobile application exercise group or a home exercise booklet group. Both groups will receive the same standardized stretching, strengthening, and range of motion exercises designed for knee osteoarthritis. The mobile app provides real-time feedback and supervision using the device's camera and artificial intelligence algorithms to track and guide exercise performance.
Participants in the app group will perform exercises with supervision via the app interface, while the control group will follow the same exercises using printed instructions. Both groups will exercise 3 to 4 times per week for 4 weeks. The study will compare pain levels, physical function, and balance before and after the intervention using validated outcome measures such as the WOMAC Index and the Visual Analog Scale.
This study may help determine whether AI-supported digital tools can improve exercise adherence and outcomes in patients with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Based Mobile Home Exercise Group | Experimental | Behavioral: AI-Supervised Mobile Exercise Program |
| Standard Home Exercise Group | Experimental | Behavioral: Booklet-Guided Home Exercise Program |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 40 and 80 years
- Diagnosed with knee osteoarthritis according to ACR criteria
- Referred to physical therapy by a physician for knee osteoarthritis
- Able to use a smartphone or tablet
- Having regular access to the internet
Key exclusion criteria (7 listed)
- History of knee surgery or currently undergoing surgical treatment
- Received physical therapy or rehabilitation for knee OA within the past 6 months
- Lack of access to a mobile device or internet
- Any neurological, cardiovascular, or musculoskeletal condition that prevents safe participation in exercise
- Cognitive impairment or psychiatric disorder interfering with exercise adherence
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-Supervised Mobile Exercise ProgramThis intervention involves the use of an artificial intelligence (AI)-supported mobile application that delivers a personalized exercise program to patients with knee osteoarthritis. The app supervises exercise execution in real time using the device's camera and AI algorithms to track movements, count repetitions, and assess form accuracy. The program includes stretching, strengthening, and range of motion exercises performed 3-4 times per week for 4 weeks. The app provides instructional videos, personalized feedback, reminders, and records user performance. No video or personal images are stored; only anonymized motion data are collected and securely stored. | Behavioural | AI-Based Mobile Home Exercise Group |
| Booklet-Guided Home Exercise ProgramThis intervention provides patients with a standardized home exercise program in printed booklet format. The program includes the same evidence-based stretching, strengthening, and range of motion exercises used in the mobile application group, performed 3-4 times per week for 4 weeks. Participants receive one-time in-person instruction on proper form but no ongoing supervision or feedback during the program. Adherence and technique are self-monitored. | Behavioural | Standard Home Exercise Group |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Baseline and Week 4
The WOMAC is a validated questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items: 5 for pain, 2 for stiffness, and 17 for physical function. Each item is scored on a 5-point Likert scale (0 = none to 4 = extreme), with a total score range of 0 to 96. Higher scores indicate worse symptoms.
Visual Analog Scale (VAS)
Time frame: Baseline and Week 4
Change in pain severity measured by the Visual Analog Scale (VAS; range: 0-10; higher scores indicate worse pain) at baseline and at 6 weeks.
Timed Up and Go (TUG) Test
Time frame: Baseline and Week 4
Functional Reach Test (FRT)
Time frame: Baseline and Week 4
Single-Leg Stance Test
Time frame: Baseline and Week 4
Exercise Execution Accuracy Assessed by Mobile Application
Time frame: Before and during the 4-week intervention
Accuracy of exercise adherence detection by the AI algorithm compared to physiotherapist assessment (% agreement)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Background: PubMed 33843948Nelligan RK, Hinman RS, Kasza J, Crofts SJC, Bennell KL. Effects of a Self-directed Web-Based Strengthening Exercise and Physical Activity Program Supported by Automated Text Messages for People With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Intern Med. 2021 Jun 1;181(6):776-785. doi: 10.1001/jamainternmed.2021.0991.
- Background: PubMed 39094114Xiang XN, Wang ZZ, Hu J, Zhang JY, Li K, Chen QX, Xu FS, Zhang YW, He HC, He CQ, Zhu SY. Telehealth-Supported Exercise or Physical Activity Programs for Knee Osteoarthritis: Systematic Review and Meta-Analysis. J Med Internet Res. 2024 Aug 2;26:e54876. doi: 10.2196/54876.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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-Supervised Mobile Exercise Program and Booklet-Guided Home Exercise Program in people with Knee Osteoarthritis, run by Uludag University at 1 site in Turkey (Türkiye).
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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 6 May 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 Turkey (Türkiye). 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: Baseline and Week 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07066514, which also lists 2 linked publications.
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 6 May 2026.