Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000300370
Ethics application status
Approved
Date submitted
28/05/2008
Date registered
17/06/2008
Date last updated
17/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postural characterization and gait in high-heeled shoe female adolescents users
Scientific title
Postural characterization and gait in high-heeled shoe female adolescents users
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gait Disorders 3187 0
Postural Disorders 3188 0
Condition category
Condition code
Musculoskeletal 3351 3351 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
Assessment on high-heeled female shoes influence in the adolescent posture and gait, which took 23 months. The subjects wore the high heels three times a week at least, for 4 hours consecutively per day, for a period of a year at least. The measurements were taken while the subjects were barefoot and then the same measurements were taken when the subjects were wearing high heels, after being with those shoes for one hour. All the subjects in this group had their posture, gait and plantar impression analysed.
Intervention code [1] 2921 0
Diagnosis / Prognosis
Comparator / control treatment
Control group is composed by adolescents who do not wear high heels frequently. All the subjects of this group had their posture, gait and plantar impression analysed as well as in the experimental group (subjects who wear high heels frequently).
Control group
Active

Outcomes
Primary outcome [1] 4298 0
Postural alterations measured by Software de Avaliacao Postural (SAPO) - in English, 'Postural Evaluation Software' - using marked anatomic points.
Timepoint [1] 4298 0
For each subject, the measurements for posture were collected in one single day (with the subject barefoot and wearing high heels) and the recordings were repeated after one week.
Primary outcome [2] 4328 0
Gait alterations measured by a Force Platform.
Timepoint [2] 4328 0
For each subject, the measurements for gait were collected in one single day (with the subject barefoot and wearing high heels) and only one recording with 2 different conditions was made for each subject.
Secondary outcome [1] 7294 0
Longitudinal Plantar Arch analysis of the sample in both assessed groups.
Timepoint [1] 7294 0
For each subject, the measurements for plantar impression were collected in one single day with the subject barefoot (without wearing the high heels during that day) and barefoot again however, after wearing high heels for one hour. Only one recording with 2 different conditions was made for each subject.

Eligibility
Key inclusion criteria
Female adolescents who are high-heeled shoes users and non-users, and with body mass index below 85% percenti.
Minimum age
13 Years
Maximum age
20 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Adolescents with congenital, orthopedical and neuromuscular pathologies. Adolescents who have physical activities more than twice a week or three hours per week.

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
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 992 0
Brazil
State/province [1] 992 0
Sao Paulo - SP

Funding & Sponsors
Funding source category [1] 3433 0
University
Name [1] 3433 0
University of Sao Paulo
Country [1] 3433 0
Brazil
Primary sponsor type
Individual
Name
Patrícia Angélica de Oliveira Pezzan
Address
Rua Estados Unidos, 191 AP 22.
Jardim Quisisana, 37701-243
Poços de Caldas - MG
Country
Brazil
Secondary sponsor category [1] 3075 0
Individual
Name [1] 3075 0
Silvia Maria Amado Joao
Address [1] 3075 0
Rua Cipotanea, 51 Cidade Universitaria, Sao Paulo 05360-000, SP
Country [1] 3075 0
Brazil
Other collaborator category [1] 295 0
Individual
Name [1] 295 0
Isabel de Camargo Neves Sacco
Address [1] 295 0
Rua Cipotanea, 51 Cidade Universitaria, Sao Paulo 05360-000, SP
Country [1] 295 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5457 0
Comissao de Etica para Analise de Projeto de Pesquisa a CAPPesq da Diretoria Clinica do Hospital das Clinicas e da Faculdade de Medicina da Universidade de Sao Paulo
Ethics committee address [1] 5457 0
Ethics committee country [1] 5457 0
Brazil
Date submitted for ethics approval [1] 5457 0
Approval date [1] 5457 0
10/11/2006
Ethics approval number [1] 5457 0
236/06

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

Contacts
Principal investigator
Name 28617 0
Address 28617 0
Country 28617 0
Phone 28617 0
Fax 28617 0
Email 28617 0
Contact person for public queries
Name 11774 0
Professora Dra. Sílvia Maria Amado João
Address 11774 0
Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional - Universidade de São Paulo.
Rua Cipotânea, 51 Cidade Universitária, São Paulo 05360-000, SP
Country 11774 0
Brazil
Phone 11774 0
+ 55 11 30918424
Fax 11774 0
+ 55 11 30917462
Email 11774 0
[email protected]
Contact person for scientific queries
Name 2702 0
Professora Dra. Sílvia Maria Amado João
Address 2702 0
Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional - Universidade de São Paulo.
Rua Cipotânea, 51 Cidade Universitária, São Paulo 05360-000, SP
Country 2702 0
Brazil
Phone 2702 0
+ 55 11 30918424
Fax 2702 0
+ 55 11 30917462
Email 2702 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
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Documents added automatically
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