NCT01590927

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 3, 2012

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

April 27, 2012

Last Update Submit

May 2, 2012

Conditions

Pelvic Floor Dyssynergia

Keywords

pelvic floorultrasonography

Outcome Measures

Primary Outcomes (1)

  • the way in x-y coordinates for the pelvic floor mouvement measured by the ultrasonography and TrakSTAR

    the mouvement of the pelvic floor is measured similtanous by the ultrasound and the TrakSTAR

    one year

Secondary Outcomes (1)

  • EMG

    one year

Study Arms (1)

20 healthy women

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

healthy women, students of the University of Applied Sciences Health

You may qualify if:

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

You may not qualify if:

  • latex and nickel allergy
  • anamnestically current pregnancy
  • menstruation
  • urogenital operations
  • anal operations
  • vaginal infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inselspital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

  • Peng Q, Jones RC, Constantinou CE. 2D Ultrasound image processing in identifying responses of urogenital structures to pelvic floor muscle activity. Ann Biomed Eng. 2006 Mar;34(3):477-93. doi: 10.1007/s10439-005-9059-3. Epub 2006 Feb 16.

    PMID: 16496082BACKGROUND

  • Sherburn M, Murphy CA, Carroll S, Allen TJ, Galea MP. Investigation of transabdominal real-time ultrasound to visualise the muscles of the pelvic floor. Aust J Physiother. 2005;51(3):167-70. doi: 10.1016/s0004-9514(05)70023-4.

    PMID: 16137242BACKGROUND

Study Officials

  • Lorenz Radlinger, PhD

    Berner Fachhochschule Gesundheit, Bern, Switzerland

    STUDY CHAIR

Central Study Contacts

Helene Moser, Msc in study

CONTACT

0041787752118helmos69@gmail.com

Study Design

Study Type
observational
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

April 27, 2012

First Posted

May 3, 2012

Study Start

August 1, 2012

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

May 3, 2012

Record last verified: 2012-05

Locations

CH(1)