Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000047099
Ethics application status
Approved
Date submitted
12/01/2010
Date registered
18/01/2010
Date last updated
18/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of trunk control on the manual function of children with myelomeningocele.
Scientific title
Assessment of trunk control on manual function in children with myelomeningocele using the In Hand Manipulation and Trunk Impairment Scale.
Secondary ID [1] 1277 0
nil
Universal Trial Number (UTN)
U1111-1113-2378
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myelomeningocele 256513 0
Condition category
Condition code
Neurological 256682 256682 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 256683 256683 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study the intervention group is composed with children who have myelomeningocele and control group with healthy children. We apply a subitem fine motor function of Epilepsis Barn Test and a range of performance in specific activities In-Hand Manipulation, who assesses the hand function; and a Trunk Impairment Scale, who assesses the trunk function in this children. This tests, is completed in a 1/2 hour session; each participant undergoes each test once only during a single session; this tests administered individually by a physiotherapist.
Intervention code [1] 255793 0
Diagnosis / Prognosis
Comparator / control treatment
The control group, composed for healthy children without myelomeningocele, receive the same treatment and the results will be compared
Control group
Active

Outcomes
Primary outcome [1] 257571 0
mean subitem fine motor function Epilepsis Barn Test score, who assesses fine motor movements of the hand.
Timepoint [1] 257571 0
at baseline
Primary outcome [2] 257572 0
mean In-Hand Manipulation score, who assesses ability of manipulate objects
Timepoint [2] 257572 0
at baseline
Primary outcome [3] 257573 0
mean Trunk Impairment Scale score, who assesses trunk motor function
Timepoint [3] 257573 0
at baseline
Secondary outcome [1] 262817 0
time taken to complete hand manupulation task
Timepoint [1] 262817 0
at baseline

Eligibility
Key inclusion criteria
The study group is composed with children who have myelomeningocele, on the other hand, the control group is composed with health children.
Minimum age
6 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
cognitive impairment interfering with comprehension tests
muscle-skeletal deformities
impaired vision and / or hearing that might have prevented their implementation.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment outside Australia
Country [1] 2400 0
Brazil
State/province [1] 2400 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 256281 0
Self funded/Unfunded
Name [1] 256281 0
Caroline Maira Moreira Pittoli
Country [1] 256281 0
Brazil
Primary sponsor type
Individual
Name
Caroline Maira Moreira Pittoli
Address
Rua 6, 2001 Rio Claro-SP CEP 13500-190
Country
Brazil
Secondary sponsor category [1] 251606 0
Hospital
Name [1] 251606 0
Ambulatorio de Fisioterapia Aplicada a Neurologia Infantil HC-UNICAMP
Address [1] 251606 0
Rua Vital Brasil, 251 Cidade Universitaria Zeferino Vaz Campinas - SP CEP 13083-887
Country [1] 251606 0
Brazil
Other collaborator category [1] 1021 0
Individual
Name [1] 1021 0
Grazielle Aurelina Fraga Sousa
Address [1] 1021 0
Rua Vital Brasil, 251 Cidade Universitaria Zeferino Vaz Campinas - SP CEP 13083-887
Country [1] 1021 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258372 0
Comite de Etica e Pesquisa da Faculdade de Ciencias Medicas da Universidade Estadual de Campinas
Ethics committee address [1] 258372 0
Ethics committee country [1] 258372 0
Brazil
Date submitted for ethics approval [1] 258372 0
01/08/2009
Approval date [1] 258372 0
13/08/2009
Ethics approval number [1] 258372 0
716/2005

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

Contacts
Principal investigator
Name 30686 0
Address 30686 0
Country 30686 0
Phone 30686 0
Fax 30686 0
Email 30686 0
Contact person for public queries
Name 13933 0
Caroline Maira Moreira Pittoli
Address 13933 0
Rua 6, 2001 Rio Claro - SP CEp 13500-190
Country 13933 0
Brazil
Phone 13933 0
55-19-92581192
Fax 13933 0
Email 13933 0
[email protected]
Contact person for scientific queries
Name 4861 0
Caroline Maira Moreira Pittoli
Address 4861 0
Rua 6, 2001 Rio Claro - SP CEP 13500-190
Country 4861 0
Brazil
Phone 4861 0
55-19-92581192
Fax 4861 0
Email 4861 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.