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

Pelvic Floor Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03903627
• Other study ID #: 0026-18-LOE
• Status: Completed
• Phase: N/A
• Start date: April 8, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: April 2019
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Pelvic Floor Muscle Weakness

Intervention

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.

Locations

Country	Name	City	State
Israel	Leowenstein hospital, Department of Physical Therapy	Ra'anana

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Ariel University

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View 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. — View 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 Ma — View Citation

Outcome

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