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

May 18, 2020 updated by: University of Haifa
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ra'anana, Israel
        • Leowenstein hospital, Department of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • transabdominal ultrasound assesment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urinary bladder displacement in millimeters during verbal instructions
Time Frame: baseline
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Consultation on Incontinence Questionnaire
Time Frame: baseline
questionnaire regarding symptoms of urinary incontinence,scale range 0-21 points. higher values represent worse outcome
baseline
pelvic floor muscles endurance of contraction in seconds
Time Frame: baseline
time of muscle contraction will be measured during the last contraction in each instruction
baseline
Functional Independence Measurement (FIM) tool
Time Frame: baseline
assess and grade the functional status of a person based on the level of assistance he or she requires
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Haifa

Collaborators

Ariel University

Investigators

  • Principal Investigator: Noa Ben-Ami, PhD, Ariel University
  • Principal Investigator: Gali Dar, PHd, University of Haifa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

April 3, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0026-18-LOE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

the result of the study will be analysed. a paper will be submitted to international journal with study description including methods, examination protocol results.

IPD Sharing Time Frame

one year following completion of study

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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