Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT07031518
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study to Identify and Validate Digital Biomarkers in Osteoarthritis of the Knee
Sponsor:
Centre Hospitalier Universitaire de Liege
Organization:
Study Overview
Official Title:
Pilot Study to Identify and Validate Digital Biomarkers in Osteoarthritis of the Knee
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DigitOAK
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: