Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000470099
Ethics application status
Approved
Date submitted
2/06/2010
Date registered
9/06/2010
Date last updated
9/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postural influence of high heels among healthy adult women.
Scientific title
Postural influence of high heels among healthy women adult women: analysis by computerized photogrammetry and Electromyography
Secondary ID [1] 251940 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural Disorders 257514 0
Condition category
Condition code
Musculoskeletal 257674 257674 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This research is a cross-sectional study comparing the trunk muscles electromiographic (EMG) activation pattern between females who often used high heels and who only used high heels sporadically. Subjects will be reported to the Laboratory for a single testing session. After cleaning the skin with isopropyl alcohol, active surface
EMG recording electrodes (Ag/Ag Cl) will placed on trunk and abdominals muscle, at standardized sites on the dominant leg, determined as the one with which they would kick a ball. A ground electrode will attached to distal tibial region . All electrodes will taped to the skin to reduce movement artifacts and remained in place throughout the study. EMG signals will sampled by a 12-bit A/D converter board with a 4 kHz frequency, and band-pass filtered at
0.01–1.5 kHz. Raw EMG data were digitally filtered at frequency bandwidth of 20–500 Hz and the root mean square (RMS) was calculated.
The subjects were photographed in the sagittal plane. First, they wore a two-piece swimsuit and no shoes, tennis and high-heeled shoes for the subsequent postural evaluation. A few anatomical points were marked out, including the occipital protuberance, C4, C7, T7, T12, L3 and L5 spinous processes, greater trochanter, anterosuperior iliac spine (ASIS), posteroinferior iliac spine (PIIS), tibial tuberosity (TT), head of the fibula, lateral malleolus, and head of the 5th toe. These markings were made with white 0.9mm-diameter PIMACO labels and orange-colored plastic rods held in place with double-sided tape.
The images were analyzed with the application SAPO (postural analysis software) version through measures of the angles formed by lines drawn between the previously marked anatomical points. This analysis identified and quantified possible asymmetries and vertebral curvature angles. The duration of study will be of 6 months. The approximate duration of the single testing session was 60-90 minutes (20 minutes with no shoes, 20 minutes with tennis shoes and 20 minutes with high-heeled shoes).The first 20 minutes involved performing a physical evaluation.
Intervention code [1] 256608 0
Not applicable
Comparator / control treatment
there is no treatment in this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258577 0
It will be evaluated the electromiographic activation from trunk and abdominal muscles in females who often used high heels and who only used high heels sporadically, using differents shoes.
Timepoint [1] 258577 0
The EMG testing will be assessed during a single 90 minute testing session.
Secondary outcome [1] 264445 0
It will be evaluated the posture in females who often used high heels and who only used high heels sporadically, using differents shoes.
Timepoint [1] 264445 0
The EMG testing will be assessed during a single 90 minute testing session.

Eligibility
Key inclusion criteria
The inclusion criterion was women who wear size 36 shoes.
The participants were divided into two groups: group 1, formed by women that wore high-heeled shoes everyday; group 2, formed by women that wore high heels occasionally to social functions.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects will be excluded if they show signs or symptoms of any of the following: musculoskeletal pathological conditions; or previous surgery of the trunk or lower limbs.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 2680 0
Brazil
State/province [1] 2680 0

Funding & Sponsors
Funding source category [1] 257100 0
University
Name [1] 257100 0
University of Pernambuco
Country [1] 257100 0
Brazil
Primary sponsor type
University
Name
University of Pernambuco
Address
Av. Agamenon Magalhaes S/N, Santo Amaro – Recife – PE
CEP 50.100-010
Country
Brazil
Secondary sponsor category [1] 256360 0
None
Name [1] 256360 0
Address [1] 256360 0
Country [1] 256360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259133 0
University of Pernambuco Ethics Commitee
Ethics committee address [1] 259133 0
Ethics committee country [1] 259133 0
Brazil
Date submitted for ethics approval [1] 259133 0
Approval date [1] 259133 0
20/11/2009
Ethics approval number [1] 259133 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31256 0
Address 31256 0
Country 31256 0
Phone 31256 0
Fax 31256 0
Email 31256 0
Contact person for public queries
Name 14503 0
Rodrigo Cappato de Araujo
Address 14503 0
BR 203 Km 2 S/N
Vila Eduardo
56300-000 - Petrolina, PE - Brasil
Country 14503 0
Brazil
Phone 14503 0
55 87 38614515
Fax 14503 0
Email 14503 0
[email protected]
Contact person for scientific queries
Name 5431 0
Rodrigo Cappato de Araujo
Address 5431 0
BR 203 Km 2 S/N
Vila Eduardo
56300-000 - Petrolina, PE - Brasil
Country 5431 0
Brazil
Phone 5431 0
55 87 38614515
Fax 5431 0
Email 5431 0
[email protected]

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.