Clinical trial NCT03903627: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Keywords: verbal cue, pelvic diaphragm, stroke
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Ariel University
First posted: 2019-04-04
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all participants will receive the same verbal instruction
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: urinary bladder displacement in millimeters during verbal instructions
timeFrame: baseline
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire
timeFrame: baseline
measure: pelvic floor muscles endurance of contraction in seconds
timeFrame: baseline
measure: Functional Independence Measurement (FIM) tool
timeFrame: baseline
Other outcomes:
Locations:
city: Ra'anana
country: Israel
facility: Leowenstein hospital, Department of Physical Therapy
Study officials:
affiliation: Ariel University
name: Noa Ben-Ami, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Haifa
name: Gali Dar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.