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

NCT07031518 | Completed

• 1 other identifier: DigitOAK
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of the Knee

Keywords

osteoarthritis of the knee; digital outcome

Outcome Measures

Primary Outcomes (4)

• Total Recording Time Over 2 Months

  Total number of hours recorded by the Syde® wearable device over a 2-month period.

  2 months

• Median Daily Recording Time

  Median number of hours recorded per day by the Syde® device over the 2-month period.

  2 months

• Days to Reach 180 Recording Hours

  Number of days required to reach 180 hours of recording, considered the optimal threshold for analysis.

  2 months

• Intra-Class Correlation of Syde® Outcomes

  Intra-Class Correlation (ICC) of each Syde® outcome calculated over slices of x hours (x = 10 to 90) of data per patient to assess reliability.

  Entire recording period over 2 months

Secondary Outcomes (7)

• Correlation Between Syde® Variables and WOMAC 3.1 Scores

  Baseline and 2 months

• Correlation Between Syde® Variables and Timed Tests

  Baseline and 2 months

• Correlation Between Syde® Variables and Kellgren-Lawrence Grade

  Baseline

• Discriminative Power of Syde® Variables

  Entire recording period over 2 months

• Qualitative Interview on Mobility and Usability

  Baseline and Month 2

Study Arms (2)

Patient with osteoarthritis of the knee

ACTIVE COMPARATOR

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.

Device: Syde; Diagnostic Test: The Self-Paced 40-meter Walk Test (SPWT); Diagnostic Test: 30-second chair stand test (30s-CST); Diagnostic Test: The Timed up and go test (TUG); Diagnostic Test: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC 3.1); Diagnostic Test: Patient global impression of severity (PGI-S); Other: Pain Level Diary; Other: Qualitative Interview

Healthy Subjects

ACTIVE COMPARATOR

Healthy subjects with similar age and BMI to patients with osteoarthritisof the knee

Device: Syde; Diagnostic Test: The Self-Paced 40-meter Walk Test (SPWT); Diagnostic Test: 30-second chair stand test (30s-CST); Diagnostic Test: The Timed up and go test (TUG)

Interventions

Syde DEVICE

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.

Healthy Subjects; Patient with osteoarthritis of the knee

The Self-Paced 40-meter Walk Test (SPWT) DIAGNOSTIC_TEST

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.

Healthy Subjects; Patient with osteoarthritis of the knee

30-second chair stand test (30s-CST) DIAGNOSTIC_TEST

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.

Healthy Subjects; Patient with osteoarthritis of the knee

The Timed up and go test (TUG) DIAGNOSTIC_TEST

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.

Healthy Subjects; Patient with osteoarthritis of the knee

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC 3.1) DIAGNOSTIC_TEST

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 with osteoarthritis of the knee

Patient global impression of severity (PGI-S) DIAGNOSTIC_TEST

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".

Patient with osteoarthritis of the knee

Pain Level Diary OTHER

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.

Patient with osteoarthritis of the knee

Qualitative Interview OTHER

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.

Patient with osteoarthritis of the knee

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead
• Centre Hospitalier Régional de la Citadelle: collaborator
• SYSNAV: collaborator

Study Sites (1)

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

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Laurent Servais, MD, PhD

  Centre Hospitalier Universitaire de Liege

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neurologist

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 22, 2025
• Study Start: May 14, 2025
• Primary Completion: November 28, 2025
• Study Completion: November 30, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

BE (1)