Osteoarthritis of the KneeDigitOAKNCT07031518
Pilot Study to Identify and Validate Digital Biomarkers in Osteoarthritis of the Knee
A study testing Syde, The Self-Paced 40-meter Walk Test (SPWT) and 30-second chair stand test (30s-CST) in people with Osteoarthritis of the Knee, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Syde, The Self-Paced 40-meter Walk Test (SPWT) and 30-second chair stand test (30s-CST)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteBelgium
- Study dates
- 14 May 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Belgium1 site
Centre de référence des maladies neuromusculaire (CRMN Liège), Hopital de la Citadelle
Liège, 4000
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Syde, The Self-Paced 40-meter Walk Test (SPWT), 30-second chair stand test (30s-CST), The Timed up and go test (TUG), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC 3.1)
- Keywords
- osteoarthritis of the knee, digital outcome
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SydeDevice
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)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.
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.
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.
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 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".
Pain Level DiaryOther
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.
Qualitative InterviewOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Recording Time Over 2 Months
Total number of hours recorded by the Syde® wearable device over a 2-month period.
Measured: 2 months
Median Daily Recording Time
Median number of hours recorded per day by the Syde® device over the 2-month period.
Measured: 2 months
Days to Reach 180 Recording Hours
Number of days required to reach 180 hours of recording, considered the optimal threshold for analysis.
Measured: 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.
Measured: Entire recording period over 2 months
Secondary outcomes (7)
Correlation Between Syde® Variables and WOMAC 3.1 Scores
Spearman correlation between digital variables and WOMAC 3.1 scores at 2 months.
Measured: Baseline and 2 months
Correlation Between Syde® Variables and Timed Tests
Correlation between digital variables and results from 40 m self-paced test, 30 s chair stand test, and timed up and go test.
Measured: Baseline and 2 months
Correlation Between Syde® Variables and Kellgren-Lawrence Grade
Spearman correlation between digital variables and Kellgren-Lawrence grade.
Measured: Baseline
Discriminative Power of Syde® Variables
Differences in Syde® outcomes between patients and controls, and among subgroups based on WOMAC 3.1 scores.
Measured: Entire recording period over 2 months
Qualitative Interview on Mobility and Usability
Qualitative data from interviews exploring mobility limitations, important measures, and impact on daily life.
Measured: Baseline and Month 2
Stiffness Index Based on Immobility
Ratio of outcome measures after 0.5-3 hours of immobility (≥10 minutes) compared to full-day values excluding immobility periods.
Measured: Entire recording period over 2 months
Optimal Time of Day for Recording
Metric properties of outcomes calculated for various time windows (e.g., 1-11h, 2-12h) to assess morning stiffness and evening fatigue.
Measured: Entire recording period over 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start14 May 2025
- Primary completion28 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle, SYSNAV
- Responsible party
- Principal investigator, Margaux POLEUR, Centre Hospitalier Universitaire de Liege
- Investigators
- Laurent Servais, MD, PhD, Study director, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031518
- Sponsor's protocol ID
- DigitOAK
- Acronym
- DigitOAK
- Status last verified
- Mar 2026
- First submitted
- 15 May 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Identify and Validate Digital Biomarkers in Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT07031518
- Acronym / sponsor ID
- DigitOAK / DigitOAK
- Conditions
- Osteoarthritis of the Knee
- Keywords
- osteoarthritis of the knee, digital outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle, SYSNAV
- Study start
- 14 May 2025 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 22 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with osteoarthritis of the knee | Active comparator | 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 InterviewPatients 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. |
| Healthy Subjects | Active comparator | 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)Healthy subjects with similar age and BMI to patients with osteoarthritisof the knee |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SydeActimyo/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. | Device | Healthy Subjects, Patient with osteoarthritis of the knee |
| 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 | Healthy Subjects, Patient with osteoarthritis of the knee |
| 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 | Healthy Subjects, Patient with osteoarthritis of the knee |
| 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 | Healthy Subjects, Patient with osteoarthritis of the knee |
| 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 with osteoarthritis of the knee |
| 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". | Diagnostic test | Patient with osteoarthritis of the knee |
| Pain Level DiaryPatients 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 | Patient with osteoarthritis of the knee |
| Qualitative InterviewThis 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. | Other | Patient with osteoarthritis of the knee |
Primary outcome
Total Recording Time Over 2 Months
Time frame: 2 months
Total number of hours recorded by the Syde® wearable device over a 2-month period.
Median Daily Recording Time
Time frame: 2 months
Median number of hours recorded per day by the Syde® device over the 2-month period.
Days to Reach 180 Recording Hours
Time frame: 2 months
Number of days required to reach 180 hours of recording, considered the optimal threshold for analysis.
Intra-Class Correlation of Syde® Outcomes
Time frame: Entire recording period over 2 months
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.
7 secondary outcomes
Correlation Between Syde® Variables and WOMAC 3.1 Scores
Time frame: Baseline and 2 months
Correlation Between Syde® Variables and Timed Tests
Time frame: Baseline and 2 months
Correlation Between Syde® Variables and Kellgren-Lawrence Grade
Time frame: Baseline
Discriminative Power of Syde® Variables
Time frame: Entire recording period over 2 months
Qualitative Interview on Mobility and Usability
Time frame: Baseline and Month 2
Stiffness Index Based on Immobility
Time frame: Entire recording period over 2 months
Optimal Time of Day for Recording
Time frame: Entire recording period over 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Servais, MD, PhD study director
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Syde, The Self-Paced 40-meter Walk Test (SPWT) and 30-second chair stand test (30s-CST) in people with Osteoarthritis of the Knee, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Recording Time Over 2 Months (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.