Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000394044
Ethics application status
Approved
Date submitted
10/05/2010
Date registered
17/05/2010
Date last updated
16/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sitting posture of children with cerebral palsy: influence of upper limbs support
Scientific title
Analysis of pressure distribution on the seat of the furniture and static balance in twelve children with cerebral palsy in the sitting position without support and with support of upper limbs in adapted table to analyse the influence of upper limbs support.
Secondary ID [1] 251724 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 257311 0
Condition category
Condition code
Neurological 257455 257455 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Data collection was performed once with patient seated on a wheelchair adapted in two situations, during three minutes each situation: without upper limbs support and with their arms supported on an adjusted table. The approximate duration between each situation was 10 minutes. The order to implement each situation was defined by lot. Data were obtained through the program of analysis of pressure sensors Conformat Research pressure mapping system applied.
Intervention code [1] 256436 0
Other interventions
Comparator / control treatment
patient sitting on a wheelchair adapted with their arms supported on an adjusted table.
Control group
Active

Outcomes
Primary outcome [1] 258379 0
peak pressure
Timepoint [1] 258379 0
This outcome was assessed by Conformat Research pressure mapping system applied with the patient sitting on a adapted wheelchair
Primary outcome [2] 258393 0
distribution of contact
Timepoint [2] 258393 0
This outcome was assessed by Conformat Research pressure mapping system applied with the patient sitting on a adapted wheelchair
Primary outcome [3] 258394 0
static balance
Timepoint [3] 258394 0
This outcome was assessed by Conformat Research pressure mapping system applied with the patient sitting on a adapted wheelchair
Secondary outcome [1] 264134 0
Nil
Timepoint [1] 264134 0
Nil

Eligibility
Key inclusion criteria
Children with spastic cerebral palsy
Sorting through the Gross Motor Function System as grade III and IV.
Minimum age
4 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children without spastic cerebral palsy

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 2602 0
Brazil
State/province [1] 2602 0

Funding & Sponsors
Funding source category [1] 256928 0
University
Name [1] 256928 0
Universidade Estadual Paulista
Country [1] 256928 0
Brazil
Primary sponsor type
Charities/Societies/Foundations
Name
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Address
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo
Country
Brazil
Secondary sponsor category [1] 256193 0
None
Name [1] 256193 0
Address [1] 256193 0
Country [1] 256193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258932 0
Comite de Etica em Pesquisa da Faculdade de Filosofia e Ciencias, Unesp - Marilia
Ethics committee address [1] 258932 0
Av. Hygino Muzzi Filho, 737
CEP: 17.525-900
Marilia - Sao Paulo
Ethics committee country [1] 258932 0
Brazil
Date submitted for ethics approval [1] 258932 0
Approval date [1] 258932 0
10/11/2008
Ethics approval number [1] 258932 0
3474/2008

Summary
Brief summary
To analyze the pressure distribution on the seat of the furniture and static balance in children with cerebral palsy in the sitting position without support and with support of upper limbs in adapted table.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31091 0
Address 31091 0
Country 31091 0
Phone 31091 0
Fax 31091 0
Email 31091 0
Contact person for public queries
Name 14338 0
Bruna Carla Perico
Address 14338 0
Avenida Hygino Muzzi Filho, 737 CEP 17525-900 Marilia Sao Paulo
Country 14338 0
Brazil
Phone 14338 0
55 14 3402-1300
Fax 14338 0
Email 14338 0
[email protected]
Contact person for scientific queries
Name 5266 0
Bruna Carla Perico
Address 5266 0
Avenida Hygino Muzzi Filho, 737 CEP 17525-900 Marilia Sao Paulo
Country 5266 0
Brazil
Phone 5266 0
55 14 3402-1300
Fax 5266 0
Email 5266 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.