Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000507482
Ethics application status
Approved
Date submitted
2/10/2007
Date registered
5/10/2007
Date last updated
5/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Skill level and body orientation affect infants' reaching
Scientific title
The effect of skill level and body orientations on infant reaching
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
health infants 2412 0
Evaluation of proximal and distal adjustments of reaching in healthy infants positioned in supine, reclined and seated body orientation 2413 0
Condition category
Condition code
Other 2518 2518 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ten infants classified as less-skilled and more-skilled reachers were evaluated both at the acquisition of reaching and after one month of spontaneous practice in three different body orientations: supine, reclined and seated positions. The infant was positioned in a baby chair. In each position, before starting the toy presentation, a 20seconds interval was allowed for infant to get used to the position. The first toy was offered for 2 minutes at the infant's midline, at shoulders height. After reach, the toy was taken away and presented again. The same procedure was follow with a second toy. The total time of the experiment was about 13 min.
Intervention code [1] 2136 0
Not applicable
Comparator / control treatment
There was no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3415 0
higher frequency of unimanual reaching in seated position and hands next to the body in reclined and seated positions for less-skilled reachers
Timepoint [1] 3415 0
Acquisition of reaching, i.e. in the first lab visit in which reaching occurred (at 4- or 5-month-old).
Primary outcome [2] 3416 0
higher frequencies of unimanual reaches (supine and seated), and hands next to the body (reclined) for less-skilled reachers. More reaches followed by grasping (seated) and hands away from the body (supine) for more-skilled reachers.
Timepoint [2] 3416 0
After one month of spontaneous practice, i.e. during the subsequent lab visit after reaching ocurred (5- or 6-month-old).
Secondary outcome [1] 5676 0
60% of less-skilled reachers and 40% of more-skilled reachers
Timepoint [1] 5676 0
acquisition of reaching, i. e. in the first lab visit in which reaching ocurred (4- or 5-month-old)

Eligibility
Key inclusion criteria
healthy full term infants;
Apgar score of greater than or equal to 8 at the first and fifth minutes; and legal consent from the partcicpants' parents.
Minimum age
4 Months
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
syndrome and genetic problems

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 614 0
Brazil
State/province [1] 614 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 2666 0
Government body
Name [1] 2666 0
Foundation for the Coordination of Higher Education and Graduate Training (CAPES foundation)
Country [1] 2666 0
Brazil
Primary sponsor type
Individual
Name
Eloisa Tudella
Address
Rodovia Washington Luis, km 235
13565-905
Sao Carlos - SP
Country
Brazil
Secondary sponsor category [1] 2410 0
University
Name [1] 2410 0
University Federal of Sao Carlos
Address [1] 2410 0
Rodovia Washington Luis, km 235
13565-905
Sao Carlos SP
Country [1] 2410 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4586 0
Research Ethics Commitee of University Federal of Sao Carlos
Ethics committee address [1] 4586 0
Rodovia Washington Luis, km 235
Sao Carlos SP
Ethics committee country [1] 4586 0
Brazil
Date submitted for ethics approval [1] 4586 0
12/12/2005
Approval date [1] 4586 0
07/03/2006
Ethics approval number [1] 4586 0
092/2006

Summary
Brief summary
The aim of this study is to verify how different body orientations affect proximal and distal reaching adjustments in 4-to6-month-old.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28081 0
Address 28081 0
Country 28081 0
Phone 28081 0
Fax 28081 0
Email 28081 0
Contact person for public queries
Name 11238 0
Raquel de Paula Carvalho
Address 11238 0
Jatoba, 275
13485-111
Limeira - SP
Country 11238 0
Brazil
Phone 11238 0
+55 19 34410239
Fax 11238 0
Email 11238 0
[email protected]
Contact person for scientific queries
Name 2166 0
Raquel de Paula Carvalho
Address 2166 0
Jatobá, 275
13485-111
Limeira - SP
Country 2166 0
Brazil
Phone 2166 0
+55 19 34410239
Fax 2166 0
Email 2166 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.