Training and reaching in premature infants

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-2dgbbz
• Date of registration: 30/10/2011
• Primary sponsor: Universidade Federal de São Carlos (UFSCar) - Brazil
• Public title: Training and reaching in premature infants
• Scientific title: Evaluation of a training on the performance of reaching in late preterm infants
• Date of first enrolment: 01/04/2011
• Target sample size: 20
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-2dgbbz/
• Study design: Randomized, single-blind, controlled, parallel-group, therapeutic clinical trial

Countries of recruitment

Brazil

Contacts

• Name: Daniele Soares
• Affiliation: Universidade Federal de São Carlos (UFSCar)

• Name: Eloisa Tudella
• Affiliation: Universidade Federal de São Carlos (UFSCar)

Key inclusion & exclusion criteria

Inclusion criteria: Infants born between 34 weeks and 36 weeks and 6 days of gestational age (late preterm infants), appropriate for gestational age, with first and fifth minute Apgar Scores greater than 7, with adequate motor performance according to the Alberta Infant Motor Scale (AIMS), without major pre- and perinatal complications, and at maternal care.
Exclusion criteria: Infants who do not attend the evaluations/training in the scheduled period (until 5 days after the infant reaching acquisition) or do not perform reaching movements at the pre-training evaluation.

Age minimum: 3M
Age maximum: 5M
Gender: -

Health Condition(s) or Problem(s) studied

Prematurity, child development, motor skills
F02.808.260
C13.703.420.491.500
F01.525.200

Intervention(s)

Intervention - Experimental Group (EG)

Frequency and total duration of the intervention: single section, with duration of 4 minutes.

Number of subjects: 10
Type of subjects: healthy late preterm human infants
Therapist's and infant's positions to perform the intervention: the therapist must sit on a mat with her back comfortably supported, legs slightly apart, and hips and knees at aproximately 120 degrees and 50 degrees of flexion, respectively. A small pillow must be placed on her knees. The infant's head must be placed on the pillow in order to encourage him/her to remain face to face with the therapist and facilitate his/her neck semi-flexion.

Intervention description: the intervention consists of a short-term whitin-section training conducted in 4 consecutive steps: 1. the therapist holds an atractive rubber object within the infant's visual field and drive the infant's right hand toward the object; this step must be carried out 3 times and also with the infant's left hand; 2. the therapist holds the object and the infant's right hand within the infant's visual field. The infant then must actively touch the object; this step must be carried out 3 times and also with the infant's left hand; 3. the therapist holds the object and uses it to apply tactile stimulus on the dorsal surface of the infant's right upper limb. The therapist must then present the object at the infant's midline in order to; 4. eliciate the infant's reaching movements. Steps 3 and 4 must be carried out 3 times and also with the infant's left hand.

Intervention - Control Group (CG):

Frequency and total duration of the intervention: single section, with duration of 4 minutes.

Number of subjects: 10
Type of subjects: healthy late preterm human infants
Therapist's and infant's positions to perform the intervention: the same descripted for the EG.
Intervention description: the therapist interacts visually and verbally, howe

Primary Outcome(s)

Reaching Performance: measured as the mean values of kinematics variables of reaching movement (straightness index, deceleration time, mean and final velocities, movement unit) and as the frequencies of uni/bimanual movements and hand opening/orientation when the infant touches the object. The gain in the reaching performance will be considered as the:

increase in the values of straightness index between pre-training and post-training;
increase in the values of deceleration time concomitant to the decrease in the values of mean and final velocities between pre-training and post-training;
decrease in the values of movement units between pre-training and post-training;
increase in the values of the frequencies of unimanual and bimanual reaches between pre-training and post-training;
increase in the values of the frequencies of open hand between pre-training and post-training;
increase in the values of the frequencies of hand vertical orientation between pre-training and post-training.

Secondary Outcome(s)

Success of Grasping: measured by the frequency of reaches with object grasping. The gain in the success of grasping will be considered as the increase in the values of the frequencies of grasps between pre-training and post-training.

Secondary ID(s)

13112.005077/2010-24

6581.0.000.135-10

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) - Brazil

Secondary Sponsor(s)

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) - Brazil