Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000818033
Ethics application status
Approved
Date submitted
29/09/2010
Date registered
30/09/2010
Date last updated
9/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of training on reaching in infants
Scientific title
Effect of supine and seated position training on spatio-temporal and frequency parameters of reaching in fullterm infants: a randomized controlled trial
Secondary ID [1] 252794 0
None
Universal Trial Number (UTN)
U1111-1117-2651
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fullterm and healthy infants with adequate motor performance 258293 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258488 258488 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The experiment consisted of a pre-training and a post-training evaluation. For a period of 4 minutes between both evaluations, two groups will be trained. Only one training session will be applied. The supine training group should be performed in infants while in the supine position on a mat. For the seated training group, the examiner should sit comfortably with the trunk supported, with the legs slightly apart, with hips and knees around 120 degrees and 50 degrees respectively. On your knees should be placed a small pillow and, on this, the infant's head. This will encourage the infant to remain face to face with the examiner, with his neck in semi-flexion, facilitating the alignment between head and trunk, and hands at the midline.
Intervention code [1] 257304 0
Rehabilitation
Intervention code [2] 257305 0
Other interventions
Comparator / control treatment
The infants in the control group were not stimulated and will remain in his mother's lap for 4 minutes. But even without training, infants will be evaluated on seated and supine positions.
Control group
Active

Outcomes
Primary outcome [1] 259314 0
Spatio-temporal patterns of reaching were recorded by four digital cameras and analyzed by the Dvideow system.
Timepoint [1] 259314 0
The experiment consisted of a pre-training and a post-training evaluation, for a period of 2 minutes in each evaluation.
Secondary outcome [1] 265762 0
Frequency of reaching were recorded by four digital cameras and analyzed by the Dvideow system.
Timepoint [1] 265762 0
The experiment consisted of a pre-training and a post-training evaluation, for a period of 2 minutes in each evaluation.

Eligibility
Key inclusion criteria
Infants with appropriate for gestational age, or to submit birth weight between the 10th and 90th percentiles on the growth curve, with Apgar scores greater than or equal to seven in first and fifth minutes, which have adequate motor performance according to the Alberta Infant Motor Scale (AIMS) and who are maternal care.
Minimum age
3 Months
Maximum age
5 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infants who are born with a gestational age below 37 weeks, low birth weight (below 2500g), with Apgar score below seven in the first and fifth minutes and with congenital central nervous system

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random allocation schedule generated by computer (Excel for Windows)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 2941 0
Brazil
State/province [1] 2941 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 257738 0
Charities/Societies/Foundations
Name [1] 257738 0
Coordination of Higher Education and Graduate Training (CAPES)
Country [1] 257738 0
Brazil
Funding source category [2] 257755 0
Charities/Societies/Foundations
Name [2] 257755 0
National Council for Scientific and Technological Development (CNPq)
Country [2] 257755 0
Brazil
Funding source category [3] 257756 0
Charities/Societies/Foundations
Name [3] 257756 0
Foundation for Supporting Research of the State of Sao Paulo (FAPESP)
Country [3] 257756 0
Brazil
Primary sponsor type
Individual
Name
Andrea Baraldi Cunha
Address
Road Washington Luiz, km 235 – Monjolinho CEP: 13.565-905, Sao Carlos- SP
Country
Brazil
Secondary sponsor category [1] 256966 0
Individual
Name [1] 256966 0
Eloisa Tudella
Address [1] 256966 0
Federal University of Sao Carlos, Physiotherapy Department
Road Washington Luiz, km 235 Monjolinho CEP: 13.565-905, Sao Carlos- SP
Country [1] 256966 0
Brazil
Other collaborator category [1] 251537 0
University
Name [1] 251537 0
Federal University of Sao Carlos, Physiotherapy Department
Address [1] 251537 0
Road Washington Luiz, km 235, Monjolinho CEP: 13.565-905, Sao Carlos- SP
Country [1] 251537 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259801 0
Research Ethics Committee - University Federal of Sao Carlos (UFSCar), Brazil
Ethics committee address [1] 259801 0
Ethics committee country [1] 259801 0
Brazil
Date submitted for ethics approval [1] 259801 0
10/09/2009
Approval date [1] 259801 0
16/12/2009
Ethics approval number [1] 259801 0
516/2009

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

Contacts
Principal investigator
Name 31714 0
Address 31714 0
Country 31714 0
Phone 31714 0
Fax 31714 0
Email 31714 0
Contact person for public queries
Name 14961 0
Andrea Baraldi Cunha
Address 14961 0
Marechal Deodoro, 1140 ap 131 CEP: 15400-000
Olimpia-SP
Country 14961 0
Brazil
Phone 14961 0
55 17 3281 3669
Fax 14961 0
Email 14961 0
[email protected]
Contact person for scientific queries
Name 5889 0
Eloisa Tudella
Address 5889 0
Vitor Manoel de Souza Lima, 328 ap 17 CEP: 13561-020
Sao Carlos-SP
Country 5889 0
Brazil
Phone 5889 0
55 16 3351 8407
Fax 5889 0
Email 5889 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.