Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000088044
Ethics application status
Not yet submitted
Date submitted
12/01/2010
Date registered
27/01/2010
Date last updated
27/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Brazilian version of the Pediatric Balance Scale in school-age children with mild to moderate motor impairment.
Scientific title
Cultural equivalence of the Brazilian Pediatric Balance Scale with the English versin in school-age child with mild to moderate motor impairment.
Secondary ID [1] 1324 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance in cerebral palsy children 256511 0
Condition category
Condition code
Physical Medicine / Rehabilitation 256678 256678 0 0
Physiotherapy
Neurological 256679 256679 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of Pediatric Balance Scale (PBS) in 60 school-age child with mild to moderate motor impairment. Forty children will be selected for the cultural adaptation process and 20 for assessment of the reliability of Brazilian PBS. The scale was administered on a one-to-one basis by physiotherapist. Ethical approval will be obtained prior to the commencement of the study from our Institutional Ethics Committee. The 14 items contained within PBS assess many of functional activities children must perform to safely and independently their daily function. The aprroximate time taken to administer the PBS is 25 minutes and it will be applied only once in each child for cultural adaptation process. For assessment of the reliability, the PBS was applied twice in each child.
Intervention code [1] 255790 0
Diagnosis / Prognosis
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257566 0
a) Translation from English to Brazilian-Portuguese and consensus version of the original PBS by two persons proficient in English;
b) Back translation of Brazilian-Portuguese version of PBS by two translators;
c)Generation of consensus version of Brazilian-Portuguese PBS.
Timepoint [1] 257566 0
In the first 6 months of the study.
Primary outcome [2] 257567 0
Cultural Equivalence of Brazilian after construction of the first version of PBS. Twenty physiotherapists specialized in the areas of pediatric and neurology will apply the first version of Brazilian PBS to 40 school-age children with mild to moderate motor impairment (administred on two children by each physioterapist). Items with more them 15% incomprehension with respect to both the instruction and response alternatives will be discussed and the items will be modified.
Timepoint [2] 257567 0
at 6 months after first version of Brazilian-Portuguese PBS.
Secondary outcome [1] 262813 0
Reliability of the measure from Brazilian final version of PBS.
To test the reliability of the Brazilian PBS, the scale will be applied to 20 children during three assessments. The first two assessments will be performed consecutively on the same day by two observers (interobserver reliability), at an interval of approximately 15 min, with either observer 1 or observer 2 applying the first assessment. The third assessment will be applied after seven days at the same time by observer 1 (intraobserver reliability).
Timepoint [1] 262813 0
at one year after Brazilian final version of PBS construction.

Eligibility
Key inclusion criteria
Children: mild to moderate motor impairment; Gross Motor Classification Level I or II.
Physiotherapist: clinical specialist in pediatric physical therapy with 3 years of experience.
Minimum age
4 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children: severe motor impairment, mental age of less than two years, attention deficit desorder, pervasive development delay, or a several receptive language disorder.
Physical Therapist: no experience in pediatric physical therapy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 2398 0
Brazil
State/province [1] 2398 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 256279 0
University
Name [1] 256279 0
University Federal of Sao Paulo
Country [1] 256279 0
Brazil
Primary sponsor type
Individual
Name
Cristina dos Santos Cardoso de Sa
Address
Rua Abilio Soares, 353, apto 94, Paraiso. Sao Paulo - SP. CEP 04005001
Country
Brazil
Secondary sponsor category [1] 251601 0
Individual
Name [1] 251601 0
Raquel de Paula Carvalho
Address [1] 251601 0
Rua Bassin Nagib Trabulsi, 125, apto 74, Ponta da Praia. Santos - SP. CEP 11030540
Country [1] 251601 0
Brazil

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258364 0
Comite de Etica em Pesquisa da Universidade Federal de Sao Paulo
Ethics committee address [1] 258364 0
Ethics committee country [1] 258364 0
Brazil
Date submitted for ethics approval [1] 258364 0
01/03/2010
Approval date [1] 258364 0
Ethics approval number [1] 258364 0

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

Contacts
Principal investigator
Name 30684 0
Address 30684 0
Country 30684 0
Phone 30684 0
Fax 30684 0
Email 30684 0
Contact person for public queries
Name 13931 0
Raquel de Paula Carvalho
Address 13931 0
Rua Bassin Nagib Trabulsi, 125, apto 74, Ponta da Praia. Santos-SP. CEP 11030540
Country 13931 0
Brazil
Phone 13931 0
+551332322569
Fax 13931 0
Email 13931 0
[email protected]
Contact person for scientific queries
Name 4859 0
Cristina dos Santos Cardoso de Sa
Address 4859 0
Rua Abilio Soares, 353, apto 94, Paraiso. Sao Paulo - SP. CEP 04005001
Country 4859 0
Brazil
Phone 4859 0
+551332322569
Fax 4859 0
Email 4859 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.