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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-35rp8x
Date of registration: 27/05/2012
Primary sponsor: Federal University of São Carlos - Brazil
Public title: Training and reaching in infants
Scientific title: Influence of training on reaching ability in infants
Date of first enrolment: 01/08/2011
Target sample size: 20
Recruitment status: recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-35rp8x/
Study type: 
Study design:  Clinical trial, parallel-group, dual-arm, single-blind, randomized controlled.  
Countries of recruitment
Brazil
Contacts
Name: Andréa  Cunha
Address:  : Rodovia Washington Luiz, Km 235 - Caixa Postal 676 - Setor de Fisioterapia em Neuropediatria 13565-905 São Carlos Brazil
Telephone: 55 16 3351-8407
Email: andreabaraldi@gmail.com
Affiliation:  Federal University of São Carlos
Name: Eloisa  Tudella
Address:  Rodovia Washington Luiz, Km 235 - Caixa Postal 676 - Setor de Fisioterapia em Neuropediatria 13565-905 São Carlos Brazil
Telephone: 55 16 3351-8407
Email: tudella@terra.com.br
Affiliation:  Federal University of São Carlos
Key inclusion & exclusion criteria
Inclusion criteria: To meet the eligibility criteria, infants had a birth weight between percentiles 10 and 90 on the growth curve, Apgar scores greater than or equal to seven in the first and fifth minutes, adequate motor performance according to the Alberta Infant Motor Scale (AIMS), were in maternal care and not in day care centers.
Exclusion criteria: Infants who are born with gestational age less than 37 weeks, low birth weight (below 2500g), with Apgar score below seven in the first and fifth minutes of life and those who submit, congenital central nervous system, signs neurological, musculoskeletal changes, diagnosis of genetic syndromes or symptoms of withdrawal symptoms associated with maternal report of abuse of alcohol and drugs, congenital infections, sensory deficits, cardiopulmonary difficulties or whose mothers have submitted episode of eclampsia or preeclampsia.

Age minimum: 3M
Age maximum: 5M
Gender: -
Health Condition(s) or Problem(s) studied
Term birth, child development, motor skills
F02.808.260
G08.686.785.760.769.490.500
F01.525.200
Intervention(s)
Intervention - Experimental Group (EG)

Frequency and total time of the intervention: 3 sessions, for 4 minutes each.

Number of participants: 10

Type of participants: healthy term human infants.

Positioning of the physiotherapist: trunk supported, with the legs slightly apart, with hips and knees flexed at about 120 ° and 50 ° degrees, respectively, measured using a goniometer. On your knees should be placed a small pillow, and on this, the head of the infant. This will encourage the infant to remain face to face with the examiner, with the neck in semi-flexion, facilitating alignment between head and trunk, and hands in the midline, within the visual field.


Description of intervention:
Each session will consist of three activities, no repetition of the same task consecutively (ie, ABC, ABC, ABC):
(A) the investigator must hold the object in one hand, in the midline and the xiphoid process at the time of the infant, and with the other hand, hold the infant's right forearm in order to lead to the same right hand toward the object to touch it. Perform this procedure three times. The same procedure should be repeated for the left hand (80segundos), (B) the investigator must hold the object in one hand, in the midline and the xiphoid process at the time of the infant, and with the other hand, hold the forearm right-infant in order to position the right hand of the same within your field of vision for a few seconds. If the infant does not touch or explore the object with the hand spontaneously, the researcher held tactile object with the right hand of the infant. This procedure should be performed three times. The same procedure should be repeated for the left hand (80 seconds), (C) the upper limbs of the infant should be positioned along the body. The researcher should proceed with tactile stimuli in the object arm and right forearm of the infant and take the object to the midline at the level of the xiphoid process, within
Primary Outcome(s)
Continuous variables of reaching performance: measured as the mean values of kinematics variables of reaching movement (movement duration,straightness index, deceleration time, mean velocity, movement unit) and total frequencies of reaching.
Secondary Outcome(s)
Categorical variables of reaching performance: the frequencies of uni/bimanual movements, hand opening/orientation when the infant touches the object and success of grasping object.
Secondary ID(s)
4292.0.000.135-09
516/2009
Source(s) of Monetary Support
Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) - Brazil
Secondary Sponsor(s)
Federal University of São Carlos - Brazil
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