Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000379213
Ethics application status
Approved
Date submitted
8/05/2009
Date registered
28/05/2009
Date last updated
28/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Motor skills in infants and adults deaf-blind
Scientific title
Comparison between motor skills observed in infants and adults deaf-blind
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
deaf-blind 4744 0
Condition category
Condition code
Neurological 237079 237079 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
A set of hand motor skill (to catch a toy, to brush the teeth, to fling an object, to dress the hair, to button and to moor), and other motor skills during standing (to kick the ball, to spin, to walk and to run) was observed if they are present or absent for infant and adult subjects. For each action composing the two sets of motor skills it was calculated the absence or presence rate in percent of total group (infant and adult). All observations were recorded in one skill test.
Intervention code [1] 236643 0
Not applicable
Comparator / control treatment
No control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5915 0
Presence rate of actions observed in two sets of motor skills (handling and standing actions). Rates was calculated by number of subjects presenting action per total of subjects (infant or adult).
Timepoint [1] 5915 0
Pesence rate of observed actions was recorded in one skill test.
Secondary outcome [1] 242167 0
Absent rate of actions observed in two sets of motor skills (handling and standing actions). Rates was calculated by number of subjects not presenting action per total of subjects (infant or adult).
Timepoint [1] 242167 0
Absent rate of observed actions was recorded in one skill test.

Eligibility
Key inclusion criteria
(1) be deaf-blind
(2) be able to walk independently
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Present any form of receptive and expresive communication

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
19
Accrual to date
Final
Recruitment outside Australia
Country [1] 1757 0
Brazil
State/province [1] 1757 0

Funding & Sponsors
Funding source category [1] 4924 0
University
Name [1] 4924 0
Universidade Municipal de Sao Caetano do Sul
Country [1] 4924 0
Brazil
Primary sponsor type
University
Name
Universidade Municipal de Sao Caetano do Sul
Address
Santo Antonio Avenue, 50, Centro, Sao Caetano do Sul, Sao Paulo
Country
Brazil
Secondary sponsor category [1] 4453 0
None
Name [1] 4453 0
Address [1] 4453 0
Country [1] 4453 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 29587 0
Address 29587 0
Country 29587 0
Phone 29587 0
Fax 29587 0
Email 29587 0
Contact person for public queries
Name 12834 0
Emerson Fachin Martins
Address 12834 0
Quadra 105, Lote 02, Bloco A, Apto 506, Aguas Claras, Brasilia, Distrito Federal
Country 12834 0
Brazil
Phone 12834 0
55 61 34352548
Fax 12834 0
Email 12834 0
[email protected]
Contact person for scientific queries
Name 3762 0
Emerson Fachin Martins
Address 3762 0
Quadra 105, Lote 02, Bloco A, Apto 506, Aguas Claras, Brasilia, Distrito Federal
Country 3762 0
Brazil
Phone 3762 0
55 61 34352548
Fax 3762 0
Email 3762 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.