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Completed

NCT Number: NCT03903627

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

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.

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Key information

Conditions

Pelvic Floor Muscle Weakness Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Leowenstein hospital, Department of Physical Therapy

Raanana, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

verbal instruction

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.

Other names: transabdominal ultrasound assesment

Primary outcomes

  1. 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

Secondary outcomes

  1. International Consultation on Incontinence Questionnaire

    Time frame: baseline

    questionnaire regarding symptoms of urinary incontinence,scale range 0-21 points. higher values represent worse outcome

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Ariel University

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2019
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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