Pilot Study to Identify and Validate Digital Biomarkers in Osteoarthritis of the Knee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Days to Reach 180 Recording Hours
研究概览
简要总结
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.
详细描述
SECONDARY OBJECTIVES
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To assess external validity
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Spearman correlation coefficient between variables and WOMAC 3.1 scores
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Spearman correlation coefficient between results and timed tests
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Spearman correlation coefficient between results and Kellgren-Lawrence grade
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Assess ability to discriminate between groups
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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
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Difference between the three groups of patients according to WOMAC 3.1 score
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Collect qualitative data: Results of qualitative interviews on significant aspects of mobility and device acceptability
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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.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Days to Reach 180 Recording Hours
时间窗: 2 months
Number of days required to reach 180 hours of recording, considered the optimal threshold for analysis.
Intra-Class Correlation of Syde® Outcomes
时间窗: 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.
Total Recording Time Over 2 Months
时间窗: 2 months
Total number of hours recorded by the Syde® wearable device over a 2-month period.
Median Daily Recording Time
时间窗: 2 months
Median number of hours recorded per day by the Syde® device over the 2-month period.
次要结局
- 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)
- Stiffness Index Based on Immobility(Entire recording period over 2 months)
- Optimal Time of Day for Recording(Entire recording period over 2 months)
研究者
Margaux POLEUR
Principal Investigator, Neurologist
Centre Hospitalier Universitaire de Liege