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Trial registered on ANZCTR


Registration number
ACTRN12617001463369p
Ethics application status
Not yet submitted
Date submitted
3/10/2017
Date registered
16/10/2017
Date last updated
16/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of high-heeled shoes on pelvic floor muscles
Scientific title
High-heeled shoes and pelvic floor muscle activity in continent women
Secondary ID [1] 293048 0
None
Universal Trial Number (UTN)
U1111-1203-0444
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress urinary incontinence 305027 0
Condition category
Condition code
Renal and Urogenital 304350 304350 0 0
Normal development and function of male and female renal and urogenital system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy women be made to stand or walk (at participant’s discretion) around with 5.08 cm (2 inches) high-heeled shoes for 30 minutes (for possible postural adjustments) before measurement of pelvic floor muscle activity and lumbar spine angle and pelvic tilt.. Participants will then be made to wear the 7.62 cm (3 inches) high-heeled shoes for 30 minutes (standing or walking around) following which measurements will be repeated. Between the two plantar flexion positions, a 10-minute rest period will be provided.
Intervention code [1] 299355 0
Early detection / Screening
Comparator / control treatment
Active (bare feet condition)
Control group
Active

Outcomes
Primary outcome [1] 303559 0
Transabdominal ultrasound for pelvic floor muscle activity
Timepoint [1] 303559 0
Four conditions: immediately prior to each high-heeled shoes condition i.e. with ankles in neutral position and ankle dorsiflexion; and following 30 minutes of standing/ walking in each high-heeled condition i.e. 2 inches and 3 inches high-heeled shoes
Secondary outcome [1] 339602 0
Spinal mouse for measurement of lumbar lordosis and pelvic inclination
Timepoint [1] 339602 0
Four conditions: immediately prior to each high-heeled shoes condition i.e. with ankles in neutral position and ankle dorsiflexion; and following 30 minutes of standing/ walking in each high-heeled condition i.e. 2 inches and 3 inches high-heeled shoes

Eligibility
Key inclusion criteria
Healthy women
Minimum age
18 Years
Maximum age
49 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women with history of recent childbirths (< 3 months), mixed or urge incontinence, previous pelvic surgeries, body mass index over 30 kg/m2, diabetes, history of smoking, chronic lung diseases, neurological problems, UTI, evidence of detrusor activity on urodynamic reports and postmenopausal women will be excluded.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9255 0
Hong Kong
State/province [1] 9255 0
kowloon

Funding & Sponsors
Funding source category [1] 297663 0
University
Name [1] 297663 0
The Hong Kong Polytechnic University
Address [1] 297663 0
11 Yuk Choi Rd,
Hung Hom
Kowloon
Hong Kong
Country [1] 297663 0
Hong Kong
Primary sponsor type
University
Name
The Hong Kong Polytechnic University
Address
11 Yuk Choi Rd,
Hung Hom
Kowloon
Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 296689 0
None
Name [1] 296689 0
Address [1] 296689 0
Country [1] 296689 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 298745 0
The Hong Kong Polytechnic University Human Subjects Ethics Committee
Ethics committee address [1] 298745 0
Ethics committee country [1] 298745 0
Date submitted for ethics approval [1] 298745 0
16/10/2017
Approval date [1] 298745 0
Ethics approval number [1] 298745 0

Summary
Brief summary
Objective and participants: To investigate if high-heeled shoes induced plantar flexion might have an impact on pelvic floor muscle activity in continent women.
Written informed consent will be obtained from all interested women. Women who provide written consent will be made to complete a sociodemographic questionnaire with the following details: age; marital status; number of successful and unsuccessful pregnancies; occupation; smoking history; history of previous pelvic surgeries; history of neurological and respiratory conditions; urinary tract infection; and foot wear; details of high-heeled shoes- heel height, number of years worn, number of hours worn each day, and number of days worn each week;
Women will undergo a 3-hour testing session. Prior to testing, they will receive information on the equipment (transabdominal ultrasound (TAS) and spinal mouse) to be used. Following this women will be briefed on preparation for ultrasound; they will be requested to void 1-hour prior to testing and then drink 500 ml of water and not urinate until after the end of the test. During assessment with TAS two tasks will be performed: a PFM contraction and a Valsalva maneuver; these two tasks will be done thrice and the mean will be calculated for analysis. TAS and evaluation of lumbar lordosis and pelvic tilt will be done in standing with ankles in four positions. Initial assessment using TAS and spinal mouse will be done with ankles in neutral position. Following this, assessment will be repeated with ankles in 20-degrees dorsiflexion (by placing wedges under the toes). A five-minute rest period will be allowed between measurements in the consecutive ankle neutral and dorsiflexion conditions. Women will then be made to stand or walk (at participant’s discretion) around with 5.08 cm (2 inches) high-heeled shoes for 30 minutes (for possible postural adjustments) before measurements are repeated. Participants will then be made to wear the 7.62 cm (3 inches) high-heeled shoes for 30 minutes (standing or walking around) following which measurements will be repeated. Between the two plantar flexion positions, a 10-minute rest period will be provided. In each ankle position, women will undergo 4D-TAS (for obtaining images at maximum PFM contraction [Valsalva]) with a 2-5.5 HMz probe. All study procedures will be carried out at the outpatient physiotherapy centre in Kwong Wah hospital. Assessments with TAS will be conducted by a physiotherapist with expertise in TAS and assisted by the principal investigator who has specialist experience in women's health. Measurement with spinal mouse will be done by the principal investigator. The TAS machine from Kwong Wah hospital and spinal mouse from HK PolyU will be used in this study.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78090 0
Dr Priya kannan
Address 78090 0
ST532
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Hong Kong
Country 78090 0
Hong Kong
Phone 78090 0
+852 60971359
Fax 78090 0
Email 78090 0
priya.kannan@polyu.edu.hk
Contact person for public queries
Name 78091 0
Dr Priya Kannan
Address 78091 0
ST532
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Hong Kong
Country 78091 0
Hong Kong
Phone 78091 0
+852 60971359
Fax 78091 0
Email 78091 0
priya.kannan@polyu.edu.hk
Contact person for scientific queries
Name 78092 0
Dr Gladys Cheing
Address 78092 0
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Hong Kong
Country 78092 0
Hong Kong
Phone 78092 0
+852 3400 6738
Fax 78092 0
Email 78092 0
gladys.cheing@polyu.edu.hk

No data has been provided for results reporting
Summary results
Not applicable