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Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Helene Moser, Moser, Helene.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590927
First Posted: May 3, 2012
Last Update Posted: May 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Helene Moser, Moser, Helene
  Purpose
Now a days the ultrasound is seen as a valid and reliable measurement tool to test the Pelvic Floor Muscle (PFM) movement (Sherburn, Murphy, Carroll, Allen, & Galea, 2005). The hypothesis is that the electromagnetic tracking system, TrakSTARTM, can measure the PFM movement in an equal or even more precise way. The TrakSTARTM will have the advantage to be used in measuring functional movements. In this Master thesis the hypothesis is to show a good reliability by trampoline jumping (physical activity).

Condition
Pelvic Floor Dyssynergia

Study Type: Observational
Official Title: Reliability and Validation of 3-D Electromagnetic Tracking During Pelvic Floor Muscle (PFM) Activation - a Pilot Study

Further study details as provided by Helene Moser, Moser, Helene:

Primary Outcome Measures:
  • the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR [ Time Frame: one year ]
    the mouvement of the pelvic floor is measured similtanous by the ultrasound and the TrakSTAR


Secondary Outcome Measures:
  • EMG [ Time Frame: one year ]
    EMG will measure the contraction of the plevic floor


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
20 healthy women

Detailed Description:

There will be two measurements. One measurement of MVIC and quick flicks will be done in a standing and supine position with 3 repetitions. The TrakSTARTM, Ultrasound, surface EMG and Accelerometer will measure the PFM movements and activation simultaneously. The Ultrasound is measured from one tester (to guaranty a high intratester reliability) (Sherburn et al., 2005).

TrakSTARTM, surface EMG and Accelerometer will measure 3 Trampoline jumps. The measurements will be done once during one hour. The women will insert the vaginal probe by themselves and stay dressed during the measurement procedure. The measurements will be done in a standardized way. All the arrangements are made to ensure the hygiene requirements.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy women, students of the University of Applied Sciences Health
Criteria

Inclusion Criteria:

  • women
  • aged between 18 and 35 years
  • anamnestically healthy
  • nulliparous and
  • a BMI between 18 and 30

Exclusion Criteria:

  • latex and nickel allergy
  • anamnestically current pregnancy
  • menstruation
  • urogenital operations
  • anal operations
  • vaginal infections
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01590927


Contacts
Contact: Helene Moser, Msc in study 0041787752118 helmos69@gmail.com

Locations
Switzerland
Inselspital Not yet recruiting
Bern, Switzerland, 3010
Contact: Helene Moser, MSc in study    0041787752118    helmos69@gmail.com   
Sponsors and Collaborators
Moser, Helene
Investigators
Study Chair: Lorenz Radlinger, PhD Berner Fachhochschule Gesundheit, Bern, Switzerland
  More Information

Publications:
Responsible Party: Helene Moser, Physiotherapist, Moser, Helene
ClinicalTrials.gov Identifier: NCT01590927     History of Changes
Other Study ID Numbers: MScPTHM
First Submitted: April 27, 2012
First Posted: May 3, 2012
Last Update Posted: May 3, 2012
Last Verified: May 2012

Keywords provided by Helene Moser, Moser, Helene:
pelvic floor
ultrasonography


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