Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000884202
Ethics application status
Approved
Date submitted
18/05/2018
Date registered
25/05/2018
Date last updated
1/11/2019
Date data sharing statement initially provided
1/11/2019
Date results information initially provided
1/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 294716 0
None
Universal Trial Number (UTN)
U1111-1212-8456
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic floor dysfunction 307592 0
Stress urinary incontinence 307593 0
Mixed urinary incontinence 307594 0
Chronic pelvic pain 307595 0
Condition category
Condition code
Alternative and Complementary Medicine 306653 306653 0 0
Other alternative and complementary medicine
Musculoskeletal 306654 306654 0 0
Other muscular and skeletal disorders
Renal and Urogenital 307000 307000 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 (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: Increase pliability, lef/right and anterior/posterior balance of soft tissues of the medial aspect of legs and floor of pelvis. Areas: Medial aspect of legs and deep outward rotators of hip.
Session 5: Increase pliability and lef/right and surface to deep balance in soft tissues spanning the anterior aspect of the pelvis and lumbar spine. Areas: Quadriceps femoris, abdominals, psoas, and iliacus.
Session 6: Increase pliability and lef/right and surface to deep balance in soft tissues spanning posterior aspect from heel to midback. Areas: Posterior aspect of feet, ankles, knees, legs, hips, pelvis, sacrum, lumbar and lower dorsal vertebra.
Session 7: Increase pliabilitiy and lef/right and anterior/posterior balance in soft tissues of the cranium and cervical spine. Areas: All aspects of neck and cranium including jaw.
Session 8: Increase soft-tissue pliability and lef/right balance in the hands, wrists, elbows, and arms; increase biomechanical flow between upper extremities and spine. Areas: Hands, wrists, forearms, elbows, upper arm, and shoulders.
Session 9: Increase soft-tissue pliability spanning the lower extremities through hips and pelvis; increase biomechanical flow between lower extremities and spine. Areas: Feet, ankles, legs, and pelvis.
Session 10: Further optimize biomechanical flow through extremities, shoulder, and pelvic girdles to spine; increase overall uniformity of tonus. Areas: as needed to optimize biomechanical integration.

All of the techniques described are performed at each session (60 minutes) per week for 10 weeks by one on one therapy. Each therapy will be done with documented session checklist by physical therapist with two year experience in structural integration,

Intervention code [1] 301034 0
Treatment: Other
Intervention code [2] 301035 0
Rehabilitation
Comparator / control treatment
Group without specialized ten sessions of structural integration.
Control group
Active

Outcomes
Primary outcome [1] 305690 0
Resting and functional bioelectrical activity of pelvic floor muscle assessed by electromyography (µV and %µV). This is a composite primary outcome.
Timepoint [1] 305690 0
24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration and follow-up after 24 hours.
Primary outcome [2] 305691 0
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.
Timepoint [2] 305691 0
24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration and follow-up after 24 hours.
Primary outcome [3] 305692 0
Body composition/ Bioelectric impedance analysis (BIA)
Timepoint [3] 305692 0
24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration and follow-up after 24 hours.
Secondary outcome [1] 346189 0
Assessment of subjective symptoms of urinary incontinence by ICIQ
Timepoint [1] 346189 0
24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration.
Secondary outcome [2] 346190 0
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)
Timepoint [2] 346190 0
24 hour before ten session of structural integration, immediately after completion ten session (ten weeks) of structural integration and follow-up after 24 hours.

Eligibility
Key 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
Minimum age
20 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key 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

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer and numbered envelopes
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The obtained results will be subjected to statistical analysis made with the STATISTICA software. For measurable variables, the arithmetic mean, standard deviation, medians and extreme values (minimum and maximum) will be calculated. Results will be compared between the groups with comparative tests (independent), as well as each group results obtained before and after therapy (dependent tests). The type of statistical tests will be depend on the fulfilment of their objectives. Statistically significant differences at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2018
Actual
1/08/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
8/07/2019
Date of last data collection
Anticipated
22/03/2019
Actual
7/10/2019
Sample size
Target
20
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 10410 0
Poland
State/province [1] 10410 0

Funding & Sponsors
Funding source category [1] 299323 0
University
Name [1] 299323 0
Opole Medical School
Country [1] 299323 0
Poland
Primary sponsor type
University
Name
Department of Physiotherapy, Opole Medical School
Address
Katowicka 68
45-060 Opole, Poland
Country
Poland
Secondary sponsor category [1] 298591 0
None
Name [1] 298591 0
Address [1] 298591 0
Country [1] 298591 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300230 0
Opole Medical School Ethics Committee
Ethics committee address [1] 300230 0
Opole Medical School's Ethics Committee
Katowicka Street 68
45-060 Opole
Poland
Ethics committee country [1] 300230 0
Poland
Date submitted for ethics approval [1] 300230 0
Approval date [1] 300230 0
09/04/2018
Ethics approval number [1] 300230 0

Summary
Brief summary
Structural integration is a movement education and manual therapy that manipulates muscle and soft tissues to loosen fascia layers, reposition muscles, and facilitate alignment. To obtain data on feasibility, effectiveness, and adverse events, women were randomized to parallel treatment groups of SI plus pelvic floor muscle training (PFMT) versus PFMT alone.

Hypothesis:
The SI method will impact on muscles bioelectrical activity, static body balance, body composition and foot arch parameters in women with and without pelvic floor dysfunctions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82990 0
Mrs Martyna Kasper-Jedrzejewska
Address 82990 0
Department of Physiotherapy, Opole Medical School
Opole 45-060
Katowicka 68 street
Country 82990 0
Poland
Phone 82990 0
+48576578777
Fax 82990 0
Email 82990 0
kasperm@wsm.opole.pl
Contact person for public queries
Name 82991 0
Dr Grzegorz Jedrzejewski
Address 82991 0
Department of Physiotherapy, Opole Medical School
Opole 45-060
Katowicka 68 street
Country 82991 0
Poland
Phone 82991 0
+48512311696
Fax 82991 0
Email 82991 0
jedrzejewskig@wsm.opole.pl
Contact person for scientific queries
Name 82992 0
Dr Grzegorz Jedrzejewski
Address 82992 0
Department of Physiotherapy, Opole Medical School
Opole 45-060
Katowicka 68 street
Country 82992 0
Poland
Phone 82992 0
+48512311696
Fax 82992 0
Email 82992 0
jedrzejewskig@wsm.opole.pl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.