CompletedNot Applicable

Non-invasive Measurement of Compartment Pressure: Reliability

Netherlands70 participantsStarted 2023-01-15

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥ 18 years * Proficient in speaking and reading Dutch Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Inter-class correlation

Timeframe: 1 session of approximately 90 minutes

Trial details

NCT IDNCT05720182

SponsorKay van Heeswijk

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-15

View on ClinicalTrials.gov More CEC Syndrome trials