RecruitingNANCT07434011

Efficacy of Artificial Intelligence-Assisted Therapeutic Exercise in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial

Sponsor: Universidad Complutense de Madrid

Trial Details

ConditionKnee Osteoarthritis
InterventionAI-Assisted Exercise Program; Paper-Based Home Exercise Program
PhaseNA
StatusRecruiting
Participants84
Est. Completion15 Mar 2027
Last Updated18 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

Spain
View Registry Entry

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