Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000162314
Ethics application status
Approved
Date submitted
24/11/2016
Date registered
30/01/2017
Date last updated
30/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Electromyographic evaluation of the effect of pelvic floor muscle training to improve the function of the lower urinary tract in women with ischemic stroke
Scientific title
Electromyographic evaluation of the effect of pelvic floor muscle training to improve the function of the lower urinary tract in women with ischemic stroke: a prospective, randomized study with a control group.
Secondary ID [1] 290618 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary incontinence 301118 0
ischemic stroke 301119 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300891 300891 0 0
Physiotherapy
Stroke 301135 301135 0 0
Ischaemic
Renal and Urogenital 301136 301136 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned to one of two comparison groups: A group - group, which will be used pelvic floor muscle training and B group (control) - a group without specialized training of the pelvic floor muscles. In group A will be applied the pelvic floor muscle training. Therapy will be held for ten days (two weeks at five sessions per week) and each will last about 30 minutes a day. The whole therapy will be carried out under the supervision of a therapist at the hospital. Participants will be recruited from among patients of the hospital Selection of exercises will be individual determined, in depends on the function of the lower urinary tract and the condition of the tested women (physiotherapist decision). Training will take into account the contractions of the pelvic floor muscles. Participants will perform contraction lasting a few seconds (depending on the condition of the patient, with a break lasts twice as long). They will also be carried out short, rapid contraction of this muscle. In this training, a electromyograph with the function of the visual biofeedback will be used. Feedback on muscle contraction provided via a screen for participants throughout each session via sEMG sensors. Each training session will be supervised and managed by a physiotherapist.
Intervention code [1] 296491 0
Rehabilitation
Intervention code [2] 296691 0
Treatment: Other
Comparator / control treatment
Group without specialized pelvic floor muscle training
Control group
Active

Outcomes
Primary outcome [1] 300293 0
Resting and functional bioelectrical activity of pelvic floor muscle assessed by electromyography
Timepoint [1] 300293 0
Before intervention, on completion of intervention and 10 days after completion of intervention
Secondary outcome [1] 329638 0
Assessment of subjective symptoms of urinary incontinence by ICIQ
Timepoint [1] 329638 0
Before intervention, on completion of intervention and 10 days after completion of intervention

Eligibility
Key inclusion criteria
ischaemic stroke episode for at least 6 months previously, the incidence of symptoms of lower urinary tract (urinary incontinence), consent to participate in research, permission doctor and general well-being of the survey
Minimum age
40 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
aphasia sensory, significant abdominal obesity (BMI> 30), previous surgery within the abdominal wall and / or pelvic, people with limited abilities functional (Barthel index <60), age over 75 years, incontinence grade III, fecal incontinence, gynecological surgeries, the lack of consent of the person tested and the lack of consent doctor to perform measurements, malaise on the study, contraindications measurements - infection, menstruation, allergic to nickel, the occurrence of pain during the study period, the resignation during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/02/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 8414 0
Poland
State/province [1] 8414 0

Funding & Sponsors
Funding source category [1] 295052 0
University
Name [1] 295052 0
Wroclaw Medical University
Country [1] 295052 0
Poland
Primary sponsor type
University
Name
Wroclaw Medical University
Address
Wybrzeze L. Pasteura 1, 50-367 Wroclaw
Poland
Country
Poland
Secondary sponsor category [1] 293862 0
Hospital
Name [1] 293862 0
Regional Specialist Hospital in Wroclaw
Address [1] 293862 0
Rehabilitation Department of Neurology, Regional Specialist Hospital in Wroclaw, ul. Poswieckiej 8, 50-001 Wroclaw,
Country [1] 293862 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296400 0
Bioethical committee at the Wroclaw Medical University
Ethics committee address [1] 296400 0
Wroclaw Medical University
Wybrzeze L. Pasteura 1, 50-367 Wroclaw
Poland
Ethics committee country [1] 296400 0
Poland
Date submitted for ethics approval [1] 296400 0
Approval date [1] 296400 0
24/06/2016
Ethics approval number [1] 296400 0
KB-367/2016

Summary
Brief summary
The primary objective of the study is electromyographic assessment of the impact of pelvic floor muscle training (MDM) to improve the function of the lower urinary tract in women after ischemic stroke.
The research will be carried out in the Department of Neurological Rehabilitation in Regional Hospital in Wroclaw. Participants in the study will be randomized to one of two comparison groups: group A - group, which will be used PFM training and group B (control) - a group without specialized training of PFM. All patients will be performed evaluation parameters included in the project at the beginning of your stay in the hospital after ten days (in group A after ten days of treatment) and after 20 days (follow up).
Resting and functional bioelectric activity of PFM will be assessed by the electromyographic device MyoSystem 1400L.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70742 0
Dr Kuba Ptaszkowski
Address 70742 0
Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, address: Grunwaldzka 2, 50-355 Wroclaw, Poland
Country 70742 0
Poland
Phone 70742 0
(+48) 606816161
Fax 70742 0
Email 70742 0
kuba.ptaszkowski@umed.wroc.pl
Contact person for public queries
Name 70743 0
Dr Kuba Ptaszkowski
Address 70743 0
Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, address: Grunwaldzka 2, 50-355 Wroclaw, Poland
Country 70743 0
Poland
Phone 70743 0
(+48) 606816161
Fax 70743 0
Email 70743 0
kuba.ptaszkowski@umed.wroc.pl
Contact person for scientific queries
Name 70744 0
Dr Kuba Ptaszkowski
Address 70744 0
Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, Faculty of Health Science, Wroclaw Medical University, address: Grunwaldzka 2, 50-355 Wroclaw, Poland
Country 70744 0
Poland
Phone 70744 0
(+48) 606816161
Fax 70744 0
Email 70744 0
kuba.ptaszkowski@umed.wroc.pl

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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