Pilot Study to Identify and Validate Digital Biomarkers in Osteoarthritis of the Knee
NCT ID: NCT07031518
Last Updated: 2025-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-05-14
2025-12-31
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Patient with osteoarthritis of the knee
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.
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.
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.
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.
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.
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.
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).
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".
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.
Healthy Subjects
Healthy subjects with similar age and BMI to patients with osteoarthritisof the knee
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
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).
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".
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
70 Years
ALL
Yes
Sponsors
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Centre Hospitalier Régional de la Citadelle
OTHER
SYSNAV
INDUSTRY
Centre Hospitalier Universitaire de Liege
OTHER
Responsible Party
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Margaux POLEUR
Principal Investigator, Neurologist
Principal Investigators
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Laurent Servais, MD, PhD
Role: STUDY_DIRECTOR
Centre Hospitalier Universitaire de Liege
Locations
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Centre de référence des maladies neuromusculaire (CRMN Liège), Hopital de la Citadelle
Liège, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DigitOAK
Identifier Type: -
Identifier Source: org_study_id
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