AI-assisted therapeutic exercise for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This parallel-group, randomized controlled trial compares an AI-assisted therapeutic exercise program delivered via a web app to a paper-based home exercise program in adults with knee osteoarthritis. Participants are adults 45 and older with persistent knee pain and stiffness, who own a smartphone and have internet access. The study aims to determine if the AI-guided program yields greater reductions in pain and improvements in knee-related function, with secondary outcomes including quality of life. Enrollment occurs at Hospital Universitario 12 de Octubre in Madrid, led by Universidad Complutense de Madrid, with collaboration from the hospital’s orthopedic department.

Why it matters

Who can join: the full rules

Inclusion Criteria (based on National Institute for Health and Care Excellence (NICE) guidance):

* Clinical criteria for KOA: age ≥45 years, activity-related knee pain, and morning knee stiffness lasting ≤30 minutes.
* Knee pain for 3 months or longer.
* Knee pain on most days during the previous month.
* Overall knee pain intensity ≥4 on an 11-point Numerical Rating Scale (NRS; 0-10) during the previous week.
* Ownership of a smartphone and ability to use a mobile application.
* Internet access at home and/or via the mobile phone.
* Ability to provide informed consent, participate, and complete study assessments.

Exclusion Criteria:

* Having a planned knee arthroplasty (knee replacement) surgery.
* Knee prosthesis/arthroplasty in the most painful knee.
* Participation in a therapeutic exercise program for knee osteoarthritis within the past 6 weeks.
* Infiltration for knee osteoarthritis within the past 12 weeks.
* Inflammatory arthritic conditions.
* A fall in the past 12 months without medical clearance to perform unsupervised home exercise.
* Being homebound during the past month without medical clearance to perform unsupervised home exercise.
* Failing the pre-exercise screening and not having medical clearance to perform unsupervised home exercise.
* Inability to communicate in Spanish.
* Any neurological or systemic disease that may limit participation in the study.

Where it's running

• Hospital Universitario 12 de Octubre
  Madrid, Madrid, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.