Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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11 November 2019 |
Main ID: |
ACTRN12618000884202 |
Date of registration:
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25/05/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Impact of ten session of structural integration on bioelectrical activity of pelvic floor muscles and their synergists, static body balance, body compostion and foot arch parameters in women with and without pelvic floor dysfunction.
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Scientific title:
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Influence of structural integration on muscles bioelectrical activity, static body balance, body composition and foot arch parameters in women with and without pelvic floor dysfunction. Randomized Clinical Trial. |
Date of first enrolment:
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01/08/2018 |
Target sample size:
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20 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12618000884202.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Poland
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Contacts
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Name:
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Dr Grzegorz Jedrzejewski
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Address:
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Department of Physiotherapy, Opole Medical School
Opole 45-060
Katowicka 68 street
Poland |
Telephone:
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+48512311696 |
Email:
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jedrzejewskig@wsm.opole.pl |
Affiliation:
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Name:
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Dr Grzegorz Jedrzejewski
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Address:
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Department of Physiotherapy, Opole Medical School
Opole 45-060
Katowicka 68 street
Poland |
Telephone:
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+48512311696 |
Email:
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jedrzejewskig@wsm.opole.pl |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Written informed consent
2. Females Aged 20-45
3. Not been previously treated with Rolfing method
4. Overall well- being on the day of examination
5. No contraindications for the sEMG measurements
Exclusion criteria: 1. The lack of consent of the examined person
2. Malaise on the examination day
3. Contraindications for electromyographic measurements: infection, menstruation,
allergies to nickel, the occurrence of pain during the examination, resignation during the examination.
4. Age over 45
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Pelvic floor dysfunction;Stress urinary incontinence;Mixed urinary incontinence;Chronic pelvic pain; Pelvic floor dysfunction Stress urinary incontinence Mixed urinary incontinence Chronic pelvic pain
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Musculoskeletal - Other muscular and skeletal disorders
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Renal and Urogenital - Other renal and urogenital disorders
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Alternative and Complementary Medicine - Other alternative and complementary medicine
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Intervention(s)
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Participants will be randomly assigned to one of two comparison groups: A group - group, which will be used pelvic floor muscle training (PFMT) and ten session of the structural integration and B group (control) - a group without specialized ten session of the structrual integration. PFMT 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. PFMT training and structural integration session will be supervised and managed by a physiotherapist. Intervention: 1. An interview 2. Instruction of the measurement and testing procedures 3. Signing the constent for participant 4. Electromyographic examination of pelvic floor muscles and their synergists with pelvic floor muscle training 5. Static body balance examination 6. Body compostion examination 7. Foot arch parameters examination
Ten series of the Structural Integration Session goals Session 1: Increase length and pliability of soft tissues on anterior aspect of torso, allowing freer respiratory movement of ribs, of soft tissues connecting shoulder girdle to rib cage, and hips to pelvis. Areas:: Lateral aspect of hips and thigh, hamstrings, lateral and frontal aspect of shoulders, front of rib cage. Session 2: Increase consistency of soft-tissue pliability in feet, ankles, and knees, increasing the support they provide the upper body. Areas: Feet, ankles, and legs to knee inclusive. Session 3: Increase anterior–posterior and cephalic–caudal pliability in soft tissues of the lateral aspect of the body, lef/right and anterior/posterior balance, increase independence of thorax from pelvis. Areas: Lateral aspects of body from hip to shoulder inclusive. Session 4:
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Primary Outcome(s)
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Resting and functional bioelectrical activity of pelvic floor muscle assessed by electromyography (µV and %µV). This is a composite primary outcome.[24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration and follow-up after 24 hours.]
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Body composition/ Bioelectric impedance analysis (BIA)[24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration and follow-up after 24 hours.]
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Static body balance with eyes opened and closed using Stabilographic platform CQ-Stabilograph (the length of the statokineziogram path on the X-axis, as well as the average speed of the COP movement on the X-axis). This is a composite primary outcome.[24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration and follow-up after 24 hours.]
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Secondary Outcome(s)
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Foot anthropometry using CQ-ST podoscope (foot length, foot width and the Wejsflog index; Clarke’s angle; hallux valgus angle and the angle of the varus deformity of the fifth toe)[24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration and follow-up after 24 hours.]
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Assessment of subjective symptoms of urinary incontinence by ICIQ [24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration.]
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Source(s) of Monetary Support
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Opole Medical School
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Ethics review
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Status: Approved
Approval date:
Contact:
Opole Medical School Ethics Committee
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Results
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Results available:
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Yes |
Date Posted:
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01/11/2019 |
Date Completed:
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07/10/2019 |
URL:
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