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

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 14, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

December 31, 2025

Conditions
Osteoarthritis of the Knee
Interventions
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.

Trial Locations (1)

4000

RECRUITING

Centre de référence des maladies neuromusculaire (CRMN Liège), Hopital de la Citadelle, Liège

All Listed Sponsors
collaborator

Centre Hospitalier Régional de la Citadelle

OTHER

collaborator

SYSNAV

INDUSTRY

lead

Centre Hospitalier Universitaire de Liege

OTHER