Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000276055
Ethics application status
Approved
Date submitted
23/03/2010
Date registered
7/04/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Psycholinguistic and school performance of brothers with myelomeningocele
Scientific title
Psycholinguistic and school performance of brothers with myelomeningocele
Secondary ID [1] 1547 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelomeningocele 257017 0
Condition category
Condition code
Other 257240 257240 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We performed assessment of psycholinguistic skills and school siblings with myelomeningocele through the application of informal procedures (in-depth interview with family members, the Communicative Behavior Observation) and formal (Picture Peabody Vocabulary Test , Illinois Test of Psycholinguistic Abilities, Profile Phonological Abilities, Test of Educational Achievement and Recognition of letters and numbers. These procedures were applied to two participants in separate rooms. The procedures were applied in the course of 4 sessions of 50 minutes, finishing the evaluation process in a month.
Intervention code [1] 256254 0
Diagnosis / Prognosis
Comparator / control treatment
There was no control group to be a case study of two siblings with myelomeningocele.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258075 0
Change in psycholinguistic skills and academic achievement with aplication of tests and symbolic actions of tools. The tests are: Observation of Communicative Behavior, Peabody Picture Vocabulary Test (PPVT - Dunn et al. 1986), Illinois Test of Psycholinguistic Abilities (ITPA - Bogossian, 1984), Phonological Abilities Profile (PAP - Alvarez, et al. 2004), School Performance Test (SPT - Stein, 1994) and recognition of letters and numbers (RLN).
Timepoint [1] 258075 0
Only one evaluation. Evaluation was conducted in 4 sessions of 50 minutes
Secondary outcome [1] 263648 0
Reflection of changes in types of environment education, family and society, assessed by aplication of tests and observastion of behaviour during the sessions. The tests are: Observation of Communicative Behavior, Peabody Picture Vocabulary Test (PPVT - Dunn et al. 1986), Illinois Test of Psycholinguistic Abilities (ITPA - Bogossian, 1984), Phonological Abilities Profile (PAP - Alvarez, et al. 2004), School Performance Test (SPT - Stein, 1994) and recognition of letters and numbers (RLN).
Timepoint [1] 263648 0
Assessed after completion of the study and analysis of data.

Eligibility
Key inclusion criteria
Low lumbar myelomeningocele between brothers.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not have low lumbar myelomeingocele

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2
Accrual to date
Final
Recruitment outside Australia
Country [1] 2556 0
Brazil
State/province [1] 2556 0

Funding & Sponsors
Funding source category [1] 256695 0
University
Name [1] 256695 0
Faculty of Dentistry of Bauru Universidade de Sao Paulo
Country [1] 256695 0
Brazil
Primary sponsor type
University
Name
Faculty of Dentistry of Bauru Universidade de Sao Paulo
Address
Al octavio Pinheiro Brisolla, 9-75. Bauru/SP. 17012-901.
Country
Brazil
Secondary sponsor category [1] 255980 0
None
Name [1] 255980 0
None
Address [1] 255980 0
None
Country [1] 255980 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258713 0
Ethics committee address [1] 258713 0
Ethics committee country [1] 258713 0
Date submitted for ethics approval [1] 258713 0
Approval date [1] 258713 0
04/03/2009
Ethics approval number [1] 258713 0

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

Contacts
Principal investigator
Name 30973 0
Address 30973 0
Country 30973 0
Phone 30973 0
Fax 30973 0
Email 30973 0
Contact person for public queries
Name 14220 0
Dionisia Aparecida Cusin Lamonica
Address 14220 0
Department of Speech
USP School of Dentistry
Al Octavio Pinheiro Brisolla 9-75
CEP 17053095
Country 14220 0
Brazil
Phone 14220 0
+55 14 32358332
Fax 14220 0
Email 14220 0
[email protected]
Contact person for scientific queries
Name 5148 0
Dionisia Aparecida Cusin Lamonica
Address 5148 0
Department of Speech
USP School of Dentistry
Al Octavio Pinheiro Brisolla 9-75
CEP 17053095
Country 5148 0
Brazil
Phone 5148 0
+ 55 14 32358332
Fax 5148 0
Email 5148 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.