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

Primary Purpose

Pelvic Floor Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
verbal instruction
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Floor Muscle Weakness focused on measuring verbal cue, pelvic diaphragm, stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leowenstein hospital, Department of Physical Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Verbal instruction

Arm Description

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.

Outcomes

Primary Outcome Measures

urinary bladder displacement in millimeters during verbal instructions
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2019
Last Updated
May 18, 2020
Sponsor
University of Haifa
Collaborators
Ariel University
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1. Study Identification

Unique Protocol Identification Number
NCT03903627
Brief Title
Effect of Verbal Instruction on Pelvic Floor Muscle Contraction in Post Stroke Patients
Official Title
Effect of Verbal Instruction on Pelvic Floor Muscle Contraction in Post Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa
Collaborators
Ariel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Muscle Weakness
Keywords
verbal cue, pelvic diaphragm, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
all participants will receive the same verbal instruction
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal instruction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
verbal instruction
Other Intervention Name(s)
transabdominal ultrasound assesment
Intervention Description
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.
Primary Outcome Measure Information:
Title
urinary bladder displacement in millimeters during verbal instructions
Description
bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool
Time Frame
baseline
Secondary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire
Description
questionnaire regarding symptoms of urinary incontinence,scale range 0-21 points. higher values represent worse outcome
Time Frame
baseline
Title
pelvic floor muscles endurance of contraction in seconds
Description
time of muscle contraction will be measured during the last contraction in each instruction
Time Frame
baseline
Title
Functional Independence Measurement (FIM) tool
Description
assess and grade the functional status of a person based on the level of assistance he or she requires
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noa Ben-Ami, PhD
Organizational Affiliation
Ariel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gali Dar, PhD
Organizational Affiliation
University of Haifa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leowenstein hospital, Department of Physical Therapy
City
Ra'anana
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
15014939
Citation
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. Erratum In: Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):311.
Results Reference
result
PubMed Identifier
25862769
Citation
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.
Results Reference
result
PubMed Identifier
30152550
Citation
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.
Results Reference
result

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

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