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

Primary Purpose

Pelvic Floor Dyssynergia

Status

Unknown status

Phase

Locations

Switzerland

Study Type

Observational

Intervention

About this trial

This is an observational trial for Pelvic Floor Dyssynergia focused on measuring pelvic floor, ultrasonography

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Inselspital

Arms of the Study

Arm 1

Arm Type

Arm Label

20 healthy women

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

EMG

EMG will measure the contraction of the plevic floor

Full Information

NCT ID

NCT01590927

First Posted

April 27, 2012

Last Updated

May 2, 2012

Sponsor

Moser, Helene

1. Study Identification

Unique Protocol Identification Number

NCT01590927

Brief Title

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

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

February 2013 (Anticipated)

Study Completion Date

May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Moser, Helene

4. Oversight

Data Monitoring Committee

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pelvic Floor Dyssynergia

Keywords

pelvic floor, ultrasonography

7. Study Design

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

20 healthy women

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

one year

Secondary Outcome Measure Information:

Title

EMG

Description

EMG will measure the contraction of the plevic floor

Time Frame

one year

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Study Population Description

healthy women, students of the University of Applied Sciences Health

Sampling Method

Non-Probability Sample

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Helene Moser, Msc in study

Phone

0041787752118

helmos69@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorenz Radlinger, PhD

Organizational Affiliation

Berner Fachhochschule Gesundheit, Bern, Switzerland

Official's Role

Study Chair

Facility Information:

Facility Name

Inselspital

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helene Moser, MSc in study

Phone

0041787752118

helmos69@gmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

16496082

Citation

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.

Results Reference

background

PubMed Identifier

16137242

Citation

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.

Results Reference

background

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

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