NCT07031518

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Centre Hospitalier Universitaire de Liege · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

SECONDARY OBJECTIVES * To assess external validity * Spearman correlation coefficient between variables and WOMAC 3.1 scores * Spearman correlation coefficient between results and timed tests * Spearman correlation coefficient between results and Kellgren-Lawrence grade * Assess ability to discriminate between groups * Difference between patients and healthy participants, and between the 50% of patients with the lowest WOMAC 3.1 score and the 50% with the highest score, and overlap between groups * Difference between the three groups of patients according to WOMAC 3.1 score * Collect qualitative data: Results of qualitative interviews on significant aspects of mobility and device acceptability * Identify a stiffness index: Ratio between outcome measurements after 0.5 - 1 - 2 or 3 hours of immobility (at least) for 10 minutes and the same outcome measured over the total recording period, excluding the 10-minute intervals. * Identify the best time of day for recording * The metric properties of the different variables will be calculated over the time periods 1-11; 1-10; 1-9; 1-8; 1-7; 1-6; 1-5; 1-4; 1-3; 1-2 and the first hour of the day in order to identify whether morning stiffness accentuates the difference between OAK and healthy participants. * The metric properties of the different variables will be calculated over the time periods 2-12; 3-12; 4-12; 5-12; 6-12; 7-12; 8-12; 9-12; 10-12; 11-12 and 12 hours of the day in order to identify whether evening fatigue accentuates the difference between OAK and healthy participants.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DEVICE	Syde	Actimyo/Syde is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
DIAGNOSTIC_TEST	The Self-Paced 40-meter Walk Test (SPWT)	Assesses walking speed over a fixed distance by having participants walk as quickly and safely as possible, but without running, along a 40-meter course.
DIAGNOSTIC_TEST	30-second chair stand test (30s-CST)	It is a simple assessment of lower body strength and endurance. Participants are instructed to stand up and sit down from a chair as many times as possible in 30 seconds.
DIAGNOSTIC_TEST	The Timed up and go test (TUG)	During this standardized test, the subject is observed and timed while he/she rises from a chair, walks 3 meters, performs a 180° turn, walk back toward the chair and sits down.
DIAGNOSTIC_TEST	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC 3.1)	The WOMAC is a widely used self-administered health status measure for evaluating pain, stiffness, and function in patients with osteoarthritis of the hip or knee. The WOMAC measures three separate dimensions: pain (5 questions), stiffness (2 questions) and function (17 questions).
DIAGNOSTIC_TEST	Patient global impression of severity (PGI-S)	The PGI-S is a patient-reported measure that evaluates the perceived severity of a condition based on a standardized scale, ranging from "none" to "very severe".
OTHER	Pain Level Diary	Patients will record their specific OAK average pain level during the day using the VAS scale of 0-10 points for one week at the beginning of each month of recording.
OTHER	Qualitative Interview	This interview is designed to better understand the patient's perspective on the impact of osteoarthritis of the knee on their motor function and to inform the selection of digital tools in upcoming clinical studies.

Timeline

• Start date: 2025-05-14
• Primary completion: 2025-11-28
• Completion: 2025-11-30
• First posted: 2025-06-22
• Last updated: 2026-03-24

Locations

1 site across 1 country: Belgium