At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Validation of CPM#1 Compressibility in Healthy Volunteers in Rest and After Exercise
In Brief
A clinical study evaluating Compremium Compressibility Measurement, Treadmill Running, and 1 other intervention for CEC Syndrome. Completed, enrolled 70 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
CPM#1 measurements: Step 1: Manual investigation to identify the compartment for compressibility measurements Step 2: Marking the location for compressibility measurements Step 3 - Examination with CPM#1 * Place the probe on the target area * Identify correct landmark * Compress the compartment * Increase steadily the pressure applied by the CP probe to 80 mmHg.
Exercise: Step 1: Participants will walk on a treadmill with standardized walking speed (5.0 km/hour) and slope (15%) for 5 minutes. Step 2: Immediate, one minute, and five minutes post-exercise CPM#1 measurements will be performed at one leg. Exercise and post-exercise CPM#1 measurements will be repeated for the other leg.
Questionnaires NIAPS questionnaire: Baseline NIAPS questionnaire with one additional question about leg dominance. Experience questionnaire: Scores 1-5, questioning the intensity, how painful, the nuisance, the duration of the study and the non-invasive pressure measurements.