Efficacy of Artificial Intelligence-Assisted Therapeutic Exercise in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial
Sponsor: Universidad Complutense de Madrid
Trial Details
| Condition | Knee Osteoarthritis |
| Intervention | AI-Assisted Exercise Program; Paper-Based Home Exercise Program |
| Phase | NA |
| Status | Recruiting |
| Participants | 84 |
| Est. Completion | 15 Mar 2027 |
| Last Updated | 18 May 2026 |
Primary Outcome
Pain Intensity
Eligibility Criteria
Inclusion Criteria
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.
Trial Sites
Countries
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