Pilot Study to Identify and Validate Digital Biomarkers in Osteoarthritis of the Knee

Summary

To date, treatment options for knee osteoarthritis remain limited, and their clinical evaluation is complex due to the day-to-day fluctuations in symptoms. Hospital tests provide a point-in-time measurement that is influenced by various factors (fatigue, recent activity, weather, etc.), making reliable assessment difficult. The aim of the study is to assess the feasibility and acceptability of monitoring actual activity using the Syde® portable device in up to 30 subjects. Numerical variables derived from data collected by Syde® will be compared with conventional on-site clinical assessment criteria and with data from healthy participants, in order to identify a reliable and robust metric, thereby improving treatment evaluation and personalised patient management. MAIN OBJECTIVES * Evaluate the use of the device * Identify numerical variables and determine the optimal time window for evaluation Patients will have two visits: one at inclusion and a second two months later. They will wear Syde® magneto-inertial sensors, one on each ankle, for the month following the initial visit, then a Syde® sensor on the ankle and another on the wrist on the side of the non-dominant hand for the following month. The total duration of the recording period is two months.

Eligibility

Inclusion Criteria:

* Patients with bi- or unilateral Knee Osteoarthritis as confirmed by a qualified rheumatologist/orthopaedist or rehabilitation doctor and having had at least one X-ray or MRI for diagnosis confirmation with Kellgren-Lawrence grade minimum 1
* WOMAC 3.1 total score at screening indicating mild, moderate, or severe symptoms in the past 48 hours
* BMI below 35.0 kg/m2

Exclusion Criteria:

* Patients with significant cognitive disorders, limiting the understanding of the exercises to be performed or the presence of apparent communication difficulties hindering the correct collection of data.
* Unable to walk independently (10 meters without any type of external help)
* History of any joint replacement surgery.
* Currently undergoing or had corticosteroid injections within the past 3 weeks.
* Underwent knee surgery in the past 6 months.
* Expecting joint replacement surgery or arthroscopy within 3 months.
* Pregnant women or women planning to become pregnant during the study
* Presence of any other conditions than osteoarthritis (musculoskeletal or neurological) that may affect normal gait. OA in other joints is not considered as an exclusion criterion as long as OAK is the most significant cause of walking impairment.

Conditions2

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