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Non-invasive Measurement of Compartment Pressure: Reliability

NCT05720182 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-11-26

No results posted yet for this study

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.

Conditions

  • CEC Syndrome

Interventions

DEVICE

Compremium Compressibility Measurement

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.

PROCEDURE

Treadmill Running

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.

OTHER

Questionnaire

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.

Sponsors & Collaborators

  • CPM Sport AG Bern

    collaborator UNKNOWN

  • Kay van Heeswijk

    lead OTHER

Principal Investigators

  • Marc RM Scheltinga, Dr · Máxima Medisch Centrum

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2024-02-15
Completion
2024-02-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05720182 on ClinicalTrials.gov