Effect of Verbal Instruction on Pelvic Floor Muscle Contraction in Post Stroke Patients

NCT ID: NCT03903627

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-08

Study Completion Date

2020-02-01

Brief Summary

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The aim of this study is to investigate which verbal instruction will lead to the most efficient contraction of pelvic floor muscles in post stroke patients. Pelvic floor muscle contraction will be evaluated via transabdominal ultrasound. ultrasound.

Detailed Description

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Sub-acute stroke patients during the rehabilitation period in the rehabilitation hospital will be examined. Each participant will be asked to contract the pelvic floor muscles using three different verbal instructions: (1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating". Those who will not be able to contract will be taught by the ultrasound as a biofeedback.

The assessment of pelvic floor contraction will be measured by measuring bladder displacement via abdominal ultrasound. A curved linear array transducer will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. An on screen caliper and measurement tool will be used to measure bladder displacement.

Conditions

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Pelvic Floor Muscle Weakness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

all participants will receive the same verbal instruction
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Verbal instruction

The participants will be verbal instructed to contract the pelvic floor muscle with the following sentences:

(1) "contract your pelvic floor - all sphincters"; (2) "contract your anus"; (3) "contract your pelvic floor as if you're trying to stop urinating".

Those who will not be able to contract will be taught by the ultrasound as a biofeedback.

Group Type EXPERIMENTAL

verbal instruction

Intervention Type OTHER

Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.

Interventions

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verbal instruction

Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.

Intervention Type OTHER

Other Intervention Names

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transabdominal ultrasound assesment

Eligibility Criteria

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Inclusion Criteria

* one to 6 months post first stroke
* understand the language and simple instruction
* willing to participate in the study
* mini mental assessment \>21

Exclusion Criteria

* Aphasia
* side neglect
* active urinary tract infection
* has been treated before for pelvic floor rehabilitation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ariel University

OTHER

Sponsor Role collaborator

University of Haifa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Noa Ben-Ami, PhD

Role: PRINCIPAL_INVESTIGATOR

Ariel University

Gali Dar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Haifa

Locations

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Leowenstein hospital, Department of Physical Therapy

Raanana, , Israel

Site Status

Countries

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Israel

References

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Tibaek S, Jensen R, Lindskov G, Jensen M. Can quality of life be improved by pelvic floor muscle training in women with urinary incontinence after ischemic stroke? A randomised, controlled and blinded study. Int Urogynecol J Pelvic Floor Dysfunct. 2004 Mar-Apr;15(2):117-23; discussion 123. doi: 10.1007/s00192-004-1124-1. Epub 2004 Jan 31.

Reference Type RESULT
PMID: 15014939 (View on PubMed)

Shin DC, Shin SH, Lee MM, Lee KJ, Song CH. Pelvic floor muscle training for urinary incontinence in female stroke patients: a randomized, controlled and blinded trial. Clin Rehabil. 2016 Mar;30(3):259-67. doi: 10.1177/0269215515578695. Epub 2015 Apr 10.

Reference Type RESULT
PMID: 25862769 (View on PubMed)

Ben Ami N, Dar G. What is the most effective verbal instruction for correctly contracting the pelvic floor muscles? Neurourol Urodyn. 2018 Nov;37(8):2904-2910. doi: 10.1002/nau.23810. Epub 2018 Aug 28.

Reference Type RESULT
PMID: 30152550 (View on PubMed)

Other Identifiers

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0026-18-LOE

Identifier Type: -

Identifier Source: org_study_id

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