Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000267257
Ethics application status
Approved
Date submitted
20/02/2009
Date registered
15/05/2009
Date last updated
15/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Body symmetry during bearing weight and functional reach in hemiparetics
Scientific title
Body symmetry during bearing weight and functional reach in hemiparetics
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
weigth bearing assymmetry 4359 0
hemiparesis 4360 0
Condition category
Condition code
Neurological 5027 5027 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Tranversal Observational Study performed in a single evaluation to record functional reach displacement and weigth bearing assymetry parameters. Functional reach was observed during three trials and weigth bearing assymetry parameters was calculated during quiet upright standing by percent of total body mass observed in individual bathroom scales under each feet.
Intervention code [1] 4093 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5481 0
wheight bearing was recorded by two bathroom scales and assymmetry for each side was calculated in percent of the total body weigth.
Timepoint [1] 5481 0
during single evalulation
Secondary outcome [1] 9234 0
trunk displacement (cm) recorded by functional reach test
Timepoint [1] 9234 0
during single evaluation

Eligibility
Key inclusion criteria
(1) be hemiparetic
(2)be able to independently stay in uprigth standing position
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
none

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment outside Australia
Country [1] 1596 0
Brazil
State/province [1] 1596 0

Funding & Sponsors
Funding source category [1] 4543 0
University
Name [1] 4543 0
Universidade Municipal de Sao Caetano do Sul
Country [1] 4543 0
Brazil
Primary sponsor type
University
Name
Universidade de Brasília
Address
QNN 14, Special Area, Ceilandia Sul, Brasilia, Distrito Federal
Country
Brazil
Secondary sponsor category [1] 4098 0
None
Name [1] 4098 0
Address [1] 4098 0
Country [1] 4098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6591 0
Faculdade de Medicina do ABC
Ethics committee address [1] 6591 0
2000, Lauro Gomes Avenue, Vila Sacadura Cabral, Santo Andre, Sao Paulo
Ethics committee country [1] 6591 0
Brazil
Date submitted for ethics approval [1] 6591 0
12/11/2007
Approval date [1] 6591 0
12/01/2008
Ethics approval number [1] 6591 0
088/2008

Summary
Brief summary
Background: Postural control is often impaired in hemiparetic conditions. During standing quietly upright, hemiparetic subjects sway more than without affected hemibody subjects adopting asymmetric postures where non-affected leg bears more weight than affected leg. Objective: To analyze functional reach and support device dependency in chronic hemiparetics verifying correlation between functional reach displacement and weight bearing symmetry scores during standing quietly upright. Methods: Hemiparetics classified in support device dependent or independent will be included in experimental procedures to record functional reach displacement and symmetry scores.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29310 0
Address 29310 0
Country 29310 0
Phone 29310 0
Fax 29310 0
Email 29310 0
Contact person for public queries
Name 12557 0
Emerson Fachin Martins
Address 12557 0
Quadra 105, Lote 02
Country 12557 0
Brazil
Phone 12557 0
55 61 34352548
Fax 12557 0
Email 12557 0
efmartins@unb.br
Contact person for scientific queries
Name 3485 0
Emerson Fachin Martins
Address 3485 0
Quadra 105, Lote 02
Country 3485 0
Brazil
Phone 3485 0
55 61 34352548
Fax 3485 0
Email 3485 0
efmartins@unb.br

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.