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

University Hospital Center (CHU) of Liege

Status: Enrolling

Conditions: Osteoarthritis of the Knee

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07031518

DigitOAK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Patient with osteoarthritis of the knee

Active Comparator group

Description:

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.

Treatment:

Other: Qualitative Interview

Other: Pain Level Diary

Device: Syde

Diagnostic Test: The Self-Paced 40-meter Walk Test (SPWT)

Diagnostic Test: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC 3.1)

Diagnostic Test: Patient global impression of severity (PGI-S)

Diagnostic Test: 30-second chair stand test (30s-CST)

Diagnostic Test: The Timed up and go test (TUG)

Healthy Subjects

Active Comparator group

Description:

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

Treatment:

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)