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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
Recruitment status was: Not yet recruiting
Sponsor:
Moser, Helene
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
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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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01590927
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 |
Keywords provided by Helene Moser, Moser, Helene:
|
pelvic floor ultrasonography |
ClinicalTrials.gov processed this record on September 21, 2017