NCT03903627

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 3, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

April 8, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

May 19, 2020

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

April 3, 2019

Last Update Submit

May 18, 2020

Conditions

Pelvic Floor Muscle Weakness

Keywords

verbal cue, pelvic diaphragm, stroke

Outcome Measures

Primary Outcomes (1)

  • urinary bladder displacement in millimeters during verbal instructions

    bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool

    baseline

Secondary Outcomes (3)

  • International Consultation on Incontinence Questionnaire

    baseline

  • pelvic floor muscles endurance of contraction in seconds

    baseline

  • Functional Independence Measurement (FIM) tool

    baseline

Study Arms (1)

Verbal instruction

EXPERIMENTAL

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

Interventions

verbal instructionOTHER

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.

Also known as: transabdominal ultrasound assesment
Verbal instruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Aphasia
  • side neglect
  • active urinary tract infection
  • has been treated before for pelvic floor rehabilitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leowenstein hospital, Department of Physical Therapy

Raanana, Israel

Location

Related Publications (3)

  • 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.

    PMID: 15014939RESULT

  • 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.

    PMID: 25862769RESULT

  • 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.

    PMID: 30152550RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Noa Ben-Ami, PhD

    Ariel University

    PRINCIPAL INVESTIGATOR

  • Gali Dar, PhD

    University of Haifa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: all participants will receive the same verbal instruction
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

April 4, 2019

Study Start

April 8, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

May 19, 2020

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
one year following completion of study

Locations

IL(1)