Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000992202
Ethics application status
Approved
Date submitted
14/11/2009
Date registered
17/11/2009
Date last updated
17/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of balance in children with neurological disease.
Scientific title
Static equilibrium analysis in patient with Hallervorden-Spatz Syndrome: Case reporting.
Universal Trial Number (UTN)
U1111-1112-5151
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hallervorden-Spatz Syndrome 252202 0
Condition category
Condition code
Physical Medicine / Rehabilitation 252397 252397 0 0
Physiotherapy
Human Genetics and Inherited Disorders 252409 252409 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Assessment of static balance using a Berg's scale at the beginning and after one week. Each assessment takes approximately 30 minutes
Intervention code [1] 241554 0
Early detection / Screening
Comparator / control treatment
is a case reporting
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253275 0
Berg Scale, which evaluates the static equilibrium
Timepoint [1] 253275 0
Assessed at baseline and after one week
Secondary outcome [1] 262270 0
Spasticity as measured by the Modified Ashworth Scale
Timepoint [1] 262270 0
Assessed at baseline and after one week

Eligibility
Key inclusion criteria
Have the Hallervorden-Spatz syndrome
Minimum age
9 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
don't have the syndrome

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Having the syndrome diagnosis and referral for physiotherapy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not a randomized
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
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1
Accrual to date
Final
Recruitment outside Australia
Country [1] 2334 0
Brazil
State/province [1] 2334 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 244018 0
Other Collaborative groups
Name [1] 244018 0
Ambulatorio de Fisioterapia em Neuropediatria
Country [1] 244018 0
Brazil
Primary sponsor type
Hospital
Name
Hospital de Clinicas - HCFM-UNICAMP
Address
Rua Vital Brasil, 251 Cidade Universitaria Zeferino Vaz Campinas Sao Paulo Brasil
CEP: 13081-970
Country
Brazil
Secondary sponsor category [1] 251369 0
Individual
Name [1] 251369 0
Marina Junqueira Airoldi
Address [1] 251369 0
Rua Vital Brasil, 251 Cidade Universitaria Zeferino Vaz Campinas Sao Paulo Brasil
CEP: 13081-970
Country [1] 251369 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258127 0
Comite de Etica da Faculdade de Ciencias Medicas da Universidade de Campinas (FCM-UNICAMP)
Ethics committee address [1] 258127 0
Ethics committee country [1] 258127 0
Brazil
Date submitted for ethics approval [1] 258127 0
08/06/2009
Approval date [1] 258127 0
23/06/2009
Ethics approval number [1] 258127 0
511/2009

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

Contacts
Principal investigator
Name 30513 0
Address 30513 0
Country 30513 0
Phone 30513 0
Fax 30513 0
Email 30513 0
Contact person for public queries
Name 13760 0
Caroline Maira Moreira Pittoli
Address 13760 0
Rua 6 n 2001 Rio Claro Sao Paulo
CEP: 13500-190
Country 13760 0
Brazil
Phone 13760 0
55-19-92581192
Fax 13760 0
Email 13760 0
carolinemmp@hotmail.com
Contact person for scientific queries
Name 4688 0
Caroline Maira Moreira Pittoli
Address 4688 0
Rua 6 n 2001 Rio Claro Sao Paulo
CEP:13500-190
Country 4688 0
Brazil
Phone 4688 0
55-19-92581192
Fax 4688 0
Email 4688 0
carolinemmp@hotmail.com

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.