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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 because the information has not been verified recently.
Verified May 2012 by Moser, Helene.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Helene Moser, Moser, Helene
ClinicalTrials.gov Identifier:
NCT01590927
First received: April 27, 2012
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    the mouvement of the pelvic floor is measured similtanous by the ultrasound and the TrakSTAR


Secondary Outcome Measures:
  • EMG [ Time Frame: one year ] [ Designated as safety issue: No ]
    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
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 27, 2012
Last Updated: May 2, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by Moser, Helene:
pelvic floor
ultrasonography

ClinicalTrials.gov processed this record on September 23, 2016