Validation of CPM#1 Compressibility in Healthy Volunteers in Rest and After Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Inter-class correlation
研究概览
简要总结
The investigators want to investigate the reliability (variability) of a new device, that should be able to measure lower leg compartment pressure non-invasively. Therefore the tool is used under different circumstances. The introduced differences in circumstances are:
- Measurements at several time points
- Measurements using different anatomical landmarks
- Measurements by different researchers
- Measurements in rest and after exercise
This study's results are important to create a reliable measurement tools for patients with lower leg symptoms. In this way the diagnosis can be improved and as well the treatments given to the patients.
It is expected that the variability of the device will be low compared to current techniques.
详细描述
Chronic Exertional Compartment Syndrome (CECS) is one of the exercise-induced lower leg pathologies. Recognition by patients and physicians is not optimal. As a consequence, many patients are undiagnosed and are forced to stop their sporting activities. To diagnose CECS, a doctor should be alerted by a patient's history and a physical examination. If both suggestive of CECS, an invasive intra compartmental pressure measurement (ICPM) in the affected compartment may be performed. During the ICPM a catheter is placed into the muscle via a hollow needle. The ICPM is not flawless in terms of accuracy and reproducibility and has a low intra-observer reproducibility. Moreover, haematoma or other tissue damage may occur following an ICPM. Nevertheless, this invasive ICPM is in 2022 still considered the 'gold-standard' diagnostic tool for CECS, in the absence of a better one.
A novel non-invasive tool for CECS is possibly provided by measuring muscle tissue compressibility. The idea is, that muscle tissue with a high pressure (as in CECS patients) requires more external force to compress, compared to tissue with a low pressure. The study device used in this study, the CPM#1 device, is based on this principle. The CPM#1 device is non-invasive, not painful, very user friendly, and the measurement can be executed as an 'office procedure' in a couple of minutes. This study will focus on determining the reliability of the device in healthy volunteers.
The primary objective is
- To validate the inter-observer reliability of compressibility measurements with the CPM#1 device during rest in healthy volunteers.
Secondary objectives are
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
No true masking possible, as the study only uses healthy participants and all participants will get measurements to both legs.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years
- •Proficient in speaking and reading Dutch
排除标准
- •Presence of complaints suggestive of CECS, previously diagnosed with CECS or previous positive ICPM
- •History of surgery or other trauma which penetrated the fascia of the leg
- •Other concurrent limb pathologies or anomalies amongst others:
- •Peripheral arterial or venous disease
- •Muscle disorders, diabetes mellitus, peripheral neuropathies
- •Unable to exercise for five minutes
- •Open wound or painful bruise less than one week ago at site of measurement
结局指标
主要结局
Inter-class correlation
时间窗: 1 session of approximately 90 minutes
The primary endpoint of inter-observer variability will be the intraclass correlation coefficient (ICC) of agreement between three observers, four sites per subject, and four repetitions per measurement. The ICC will be assessed using a two-way random effects model. Both observers and subjects will be included as random effects. The first measurement for each location will be taken from every observer to calculate the ICC. Apart from that, the ICC will be measured using the average of the four repetitions of ratings, to estimate the effect on the ICC of repetitive measurements. "Good reliability" classification will be reached if the lower bound of the computed ICC confidence interval does not fall below 0.75.
次要结局
- Intra-class correlation(1 session of approximately 90 minutes)
- Exercise effect on compressibility(Directly, 1 minute, and 5 minutes post-exercise)
研究者
Kay van Heeswijk
Coordinating Investigator
Maxima Medical Center