Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000933055
Ethics application status
Approved
Date submitted
10/09/2010
Date registered
3/11/2010
Date last updated
3/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical value of identifying weight-bearing distribution types in chronic hemiparesis by digital scales
Scientific title
Clinical value of identifying weight-bearing distribution types by digital scales in adults with chronic hemiparesis secondary to stroke
Secondary ID [1] 252676 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemiparesis 258167 0
Weight-bearing distribution 258168 0
Condition category
Condition code
Stroke 258347 258347 0 0
Ischaemic
Stroke 258348 258348 0 0
Haemorrhagic

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 during approximately 5 minutes to record weight-bearing distribution in kilograms observed during quiet upright standing in individual bathroom scales under each feet and symmetry ratio calculated off-line. Overall duration of this observational study is 2 months.
Intervention code [1] 257188 0
Not applicable
Comparator / control treatment
subjects without hemiparesis
Control group
Active

Outcomes
Primary outcome [1] 259199 0
weight-bearing distribution assessed by two parallel bathroom scales under each foot
Timepoint [1] 259199 0
during single evaluation
Secondary outcome [1] 265571 0
symmetry ratio
Timepoint [1] 265571 0
off-line after single evaluation

Eligibility
Key inclusion criteria
(1) have had a post-brain injury period of over six months,
(2) have spastic hemiparesis and
(3) were able to maintain themselves upright stance during a period of time long enough to register the weight-bearing
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
participants presenting other types of disability in addition to hemiparesis

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2009
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] 2863 0
Brazil
State/province [1] 2863 0
Distrito Federal

Funding & Sponsors
Funding source category [1] 257639 0
University
Name [1] 257639 0
Universidade de Brasilia
Country [1] 257639 0
Brazil
Primary sponsor type
University
Name
Universidade de Brasilia
Address
QNN 14 Area Especial
Ceilandia Sul
CEP 72220-140
Brasilia - Distrito Federal
Country
Brazil
Secondary sponsor category [1] 256861 0
None
Name [1] 256861 0
Address [1] 256861 0
Country [1] 256861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259654 0
Faculdade de Ciencias da Saude - Universidade de Brasilia
Ethics committee address [1] 259654 0
QNN 14 Area Especial
Ceilandia Sul
CEP 72220-140
Brasilia - Distrito Federal
Ethics committee country [1] 259654 0
Brazil
Date submitted for ethics approval [1] 259654 0
08/05/2009
Approval date [1] 259654 0
07/07/2009
Ethics approval number [1] 259654 0
039/2009

Summary
Brief summary
Background and Purpose: Amount of weight-bearing is useful information during rehabilitation after stroke of subjects with hemiparesis to evaluate symmetry, weight shift ability and limb loading. For clinical examination, an easiest and cheapest technique to measuring objectively weight-bearing is procedures using scales. Then, this study aimed to analyze weight-bearing during upright stance by scales in subjects with and without hemiparesis to identify asymmetry patterns.
Methods: Forty subjects with (n=20) or without (n=20) hemiparesis were included in procedures to record weight-bearing between hemibodies. The values for each limb were registered as weight-bearing under the non-predominantly (affected/non-dominant) and predominantly (non-affected/dominant) used hemibody and they were used to calculate symmetry ratio defining asymmetry patterns.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31636 0
Address 31636 0
Country 31636 0
Phone 31636 0
Fax 31636 0
Email 31636 0
Contact person for public queries
Name 14883 0
Emerson Fachin Martins
Address 14883 0
Rua 26 Norte
Quadra 105, Lote 02, Bloco A, Apto 506
Aguas Claras, Brasilia, Distrito Federal
CEP 71915-250
Country 14883 0
Brazil
Phone 14883 0
55 61 3021 8444
Fax 14883 0
55 61 3076 6042
Email 14883 0
efmartins@unb.br
Contact person for scientific queries
Name 5811 0
Emerson Fachin Martins
Address 5811 0
Rua 26 Norte
Quadra 105, Lote 02, Bloco A, Apto 506
Aguas Claras, Brasilia, Distrito Federal
CEP 71915-250
Country 5811 0
Brazil
Phone 5811 0
55 61 3021 8444
Fax 5811 0
Email 5811 0
efmartins@unb.br

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No Supporting Document Provided



Results publications and other study-related documents

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