Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000570482
Ethics application status
Approved
Date submitted
13/10/2007
Date registered
6/11/2007
Date last updated
6/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Postural characterization of children between 7 and 8 years of age
Scientific title
Postural characterisation of children between 7 and 8 years of age for asymmetry
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural deviations 2457 0
Condition category
Condition code
Musculoskeletal 2554 2554 0 0
Normal musculoskeletal and cartilage development and function
Musculoskeletal 2626 2626 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
quantitative assessment of posture of head, shoulder (frontal and sagittal planes), scapula, thoracic kyphosis, lumbar lordosis, spine lateral deviation, pelvis, knee (frontal and sagittal planes), ankle, footprint, fingertip-to-floor test. Duration of observations was 20 minutes
Intervention code [1] 2259 0
Not applicable
Comparator / control treatment
no treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3461 0
postural deviations measured by the software CorelDraw and the bony landmarks
Timepoint [1] 3461 0
1 year and 6 months
Secondary outcome [1] 5776 0
flexibility measured with a ruler (fingertip-to-floor test)
Timepoint [1] 5776 0
1 year and 6 months

Eligibility
Key inclusion criteria
healthy children, with Body Mass Index under 85th percentile (Cole, 2000), without spine lateral deviation in “S”, and that practice physic exercise no often than twice per week and/or than three hours per week
Minimum age
7 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
children with neuromuscular, musculoskeletal and heart-breath pathologies, with spine lateral deviation in “S” kind, with BMI above 85th percentile (Cole, 2000) and that practiced institucional sport or physcic exercise more than Physical Education, more often than twice per week and/or more than 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
30/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment outside Australia
Country [1] 622 0
Brazil
State/province [1] 622 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 2701 0
Government body
Name [1] 2701 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 2701 0
Brazil
Primary sponsor type
Individual
Name
Patrícia Jundi Penha
Address
Rua Domingos de Morais, 1457 apto 62 04009-003 Vila Mariana São Paulo, SP
Country
Brazil
Secondary sponsor category [1] 2445 0
Individual
Name [1] 2445 0
Silvia Maria Amado Joao
Address [1] 2445 0
Rua Cipotanea, 51 Cidade Universitaria, Sao Paulo 05360-000, SP
Country [1] 2445 0
Brazil
Other collaborator category [1] 71 0
Individual
Name [1] 71 0
Marina Baldini
Address [1] 71 0
Rua do Recanto, 29 Condominio INPLA, Granja Viana, Carapicuiba, SP, 06350-160
Country [1] 71 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4621 0
Comissao de Etica para Analise de Projetos 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] 4621 0
Ethics committee country [1] 4621 0
Brazil
Date submitted for ethics approval [1] 4621 0
Approval date [1] 4621 0
25/08/2005
Ethics approval number [1] 4621 0
218/05

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

Contacts
Principal investigator
Name 28112 0
Address 28112 0
Country 28112 0
Phone 28112 0
Fax 28112 0
Email 28112 0
Contact person for public queries
Name 11269 0
Professor Dr. Sílvia Maria Amado João
Address 11269 0
Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional – Universidade de São Paulo
R. Cipotânea 51 Cidade Universitária, São Paulo 05360-000, SP
Country 11269 0
Brazil
Phone 11269 0
+ 55 11 30918424
Fax 11269 0
+ 55 11 30917462
Email 11269 0
smaj@usp.br
Contact person for scientific queries
Name 2197 0
Professor Dr. Sílvia Maria Amado João
Address 2197 0
R. Cipotânea 51 Cidade Universitária, São Paulo 05360-000, SP
Country 2197 0
Brazil
Phone 2197 0
+ 55 11 30918424
Fax 2197 0
+ 55 11 30917462
Email 2197 0
smaj@usp.br

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.