ANZCTR - Registration

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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]

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

Condition category

Condition code

Renal and Urogenital

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]

Early detection / Screening

Comparator / control treatment

Active (bare feet condition)

Control group

Active

Outcomes

Primary outcome [1]

Transabdominal ultrasound for pelvic floor muscle activity

Timepoint [1]

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]

Spinal mouse for measurement of lumbar lordosis and pelvic inclination

Timepoint [1]

Eligibility

Key inclusion criteria

Healthy women

Minimum age

18 Years

Maximum age

49 Years

Sex

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

1/11/2017

Actual

Date of last participant enrolment

Anticipated

15/12/2017

Actual

Date of last data collection

Anticipated

8/01/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Hong Kong

State/province [1]

kowloon

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Hong Kong Polytechnic University

Address [1]

11 Yuk Choi Rd,
Hung Hom
Kowloon
Hong Kong

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

The Hong Kong Polytechnic University Human Subjects Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

16/10/2017

Approval date [1]

Ethics approval number [1]

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

Dr Priya kannan

Address

ST532
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Hong Kong

Country

Hong Kong

Phone

+852 60971359

Fax

priya.kannan@polyu.edu.hk

Contact person for public queries

Name

Priya Kannan

Address

ST532
Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Hong Kong

Country

Hong Kong

Phone

+852 60971359

Fax

priya.kannan@polyu.edu.hk

Contact person for scientific queries

Name

Gladys Cheing

Address

Department of Rehabilitation Sciences
The Hong Kong Polytechnic University
Hung Hom
Hong Kong

Country

Hong Kong

Phone

+852 3400 6738

Fax

gladys.cheing@polyu.edu.hk

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

No additional documents have been identified.

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