Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000555459
Ethics application status
Approved
Date submitted
24/10/2007
Date registered
29/10/2007
Date last updated
29/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of extra weight on spontaneous kicking in 1-and-2-month-old infants
Scientific title
Effects of extra weight on spontaneous kicking in 1-and-2-month-old
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy infants 2504 0
Evaluation of frequency of kicking, frequency of feet contact with a board, uni and bipodal movements, podal preference, and intralimb coordination pattern in 1- and- 2-month-old infants with and without extra weight in their legs. 2505 0
Condition category
Condition code
Other 2600 2600 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
Eight infants aged 1 and 2 months old were placed in supine, and their kicking movements were recorded for 6 minutes and 20 seconds. In the first condition, infants were trained to kick a board. The second condition was the baseline. In third condition, there were added 1/10 of leg's weight on their ankles. In the fourth condition, there were added 1/3 of leg's weight on their ankles. The fifth condition was post-weight and it was similar to the baseline. Each condition was 1 minute and there was a 20 seconds interval between each condition.
Intervention code [1] 2232 0
Not applicable
Comparator / control treatment
There was no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3510 0
The frequency of kicking increased in the conditions of 1/10-weight and post-weight. Feet-contact with the board decreased in the condition of 1/3-weight.
Timepoint [1] 3510 0
In 1 and 2 months old.
Primary outcome [2] 3511 0
The frequency of kicking and feet-contact with the board increased at 2 months
Timepoint [2] 3511 0
Between 1 and 2 months
Secondary outcome [1] 5859 0
Unilateral kicking was predominant in all the conditions and ages, and infants showed no preference for either leg. The intralimb coordination pattern was shown to be in-phase in both ages.
Timepoint [1] 5859 0
At 1 and 2 months.

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 participants' parents.
Minimum age
1 Months
Maximum age
2 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Syndrome or 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
20/03/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 636 0
Brazil
State/province [1] 636 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 2750 0
Government body
Name [1] 2750 0
National Council for Scientific and Technological Development (CNPq)
Country [1] 2750 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] 2484 0
University
Name [1] 2484 0
University Federal of Sao Carlos
Address [1] 2484 0
Rodovia Washington Luis
km 235
13565-905
Sao Carlos SP
Country [1] 2484 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4667 0
Research Ethics Commitee of University Federal of Sao Carlos
Ethics committee address [1] 4667 0
Ethics committee country [1] 4667 0
Brazil
Date submitted for ethics approval [1] 4667 0
Approval date [1] 4667 0
16/03/2005
Ethics approval number [1] 4667 0
044/2005

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

Contacts
Principal investigator
Name 28144 0
Address 28144 0
Country 28144 0
Phone 28144 0
Fax 28144 0
Email 28144 0
Contact person for public queries
Name 11301 0
Raquel de Paula Carvalho
Address 11301 0
Jatoba 275
13485-121
Limeira SP
Country 11301 0
Brazil
Phone 11301 0
+55 19 34410239
Fax 11301 0
Email 11301 0
[email protected]
Contact person for scientific queries
Name 2229 0
Jocelene de Fatima Landgraf
Address 2229 0
Rodovia Washington Luis
km 235
Sao Carlos
Country 2229 0
Brazil
Phone 2229 0
+55 16 97141431
Fax 2229 0
Email 2229 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.