Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000557437
Ethics application status
Approved
Date submitted
10/03/2016
Date registered
29/04/2016
Date last updated
29/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence of postural changes and risk factors in school children and adolescents in north region (PORTO)
Scientific title
Prevalence of postural changes and risk factors in school children and adolescents in north region (PORTO)
Secondary ID [1] 288737 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 297976 0
Postural changes 297977 0
Condition category
Condition code
Musculoskeletal 298134 298134 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Postural evaluation was aquired by visual analysation and filling out of a form about postural habbits
Intervention code [1] 294174 0
Early Detection / Screening
Comparator / control treatment
NO control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297645 0
Low back pain using a visual analog scale
Timepoint [1] 297645 0
After questionnaire is completed
Secondary outcome [1] 321672 0
Postural changes prevalence using a form concerning postural changes.
Nordic musculoskletal questionnaire
Timepoint [1] 321672 0
After data collection was completed,

Eligibility
Key inclusion criteria
students (Children and adolescents)
Being at school at the time of data collection
informed consent (signed by parents or legal representatives)
appropriate clothes (shorts and no shirt
Minimum age
10 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
mental and motor illness
bipedestrian position disabled

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
15/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
285
Recruitment outside Australia
Country [1] 7698 0
Portugal
State/province [1] 7698 0
Porto

Funding & Sponsors
Funding source category [1] 293089 0
University
Name [1] 293089 0
Fernando Pessoa University
Country [1] 293089 0
Portugal
Primary sponsor type
University
Name
Universidade Fernando Pessoa
Address
Praca 9 de Abril 349
4249-004 Porto
Country
Portugal
Secondary sponsor category [1] 292164 0
None
Name [1] 292164 0
Address [1] 292164 0
Country [1] 292164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294596 0
Ethics Comission of Fernando Pessoa University
Ethics committee address [1] 294596 0
Praca 9 de Abril 349
4249-004 Porto
Ethics committee country [1] 294596 0
Portugal
Date submitted for ethics approval [1] 294596 0
01/07/2011
Approval date [1] 294596 0
29/07/2011
Ethics approval number [1] 294596 0

Summary
Brief summary
This study intended to evaluate postural changes in school children, and its relation to back pain risk
Trial website
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 64302 0
Prof Clarinda Festas
Address 64302 0
University Fernando Pessoa

Praca 9 de Abril 349
4249-004 Porto
Country 64302 0
Portugal
Phone 64302 0
+351225071300
Fax 64302 0
Email 64302 0
[email protected]
Contact person for public queries
Name 64303 0
Clarinda Festas
Address 64303 0
University Fernando Pessoa
Praca 9 de Abril 349
4249-004 Porto
Country 64303 0
Portugal
Phone 64303 0
+351225071300
Fax 64303 0
Email 64303 0
[email protected]
Contact person for scientific queries
Name 64304 0
Clarinda Festas
Address 64304 0
University Fernando Pessoa
Praca 9 de Abril 349
4249-004 Porto
Country 64304 0
Portugal
Phone 64304 0
+351225071300
Fax 64304 0
Email 64304 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.