Zika Virus Infection Clinical Trial
Official title:
Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection During the First or Second Trimester of Gestation.
Introduction: It is estimated that more than one million Brazilians were infected by zika virus in the last two years. Brazilian researchers first noted the virus's potential association with microcephaly. Objective: This study aimed to describe the motor performance of children aged between 6-18 months with the diagnoses of congenital Zika syndrome. Method: This is a cross-sectional, prospective and descriptive study. The study population consisted of 31 children. Participants were evaluated using Alberta Infant Motor Scale (AIMS) and Gross Motor Function Measure (GMFM).
Method This was a cross-sectional, prospective and descriptive study. This study was approved
by the Ethics Committee for Analysis of Research Projects of the University of São Paulo -
School of Arts, Sciences and Humanities - EACH, under the protocol number approved CAAE:
65822017.3.0000.5390. Parents or caregivers gave written informed consent prior to
participating. Children were evaluated by Physiotherapists who had at least two years of
neuropediatric practice in the cities of Arcoverde and Recife in Pernambuco, Brazil.
Sample Participants were evaluated in Salud Serviços de Reabilitação Clinic (Recife) and Mens
Sana Clinic (Arcoverde) using Alberta Infant Motor Scale (AIMS - prone, supine, sitting,
standing, total score and corresponding percentile) and Gross Motor Function Measure (GMFM,
A: lying/rolling and B: sitting). Head circumference at birth and on the day of assessment
(in cm), age (in months) and family income, as well as AIMS and GMFM scores, provided as
means, standard deviations, and minimum and maximum scores. Qualitative data about sex,
muscle tone (increased, decreased or normal), visual/ hearing impairments (yes or no) were
also collected.
Assessment Scales To assess performance of the children the following motor scales and
assessments were used.
1. Alberta Infant Motor Scale (AIMS) is a reliable and easy-to-use clinical assessment tool
for the evaluation of infant gross motor development from birth until the acquisition of
independent walking. AIMS is a norm-referenced measure of infant gross motor
development. It contains 58 items, which assess the control and integrity of the
antigravity muscles during observation of infant motor skills in prone, supine, sitting,
and standing positions. It has been recognized as a useful tool to assess gross motor
maturation during infancy, to trace motor delay, and to identify infants who may benefit
from early intervention Supine, prone, sitting, standing scores and the total score were
registered, as well as the age corresponding percentiles. Interpretation of an AIMS
score is never made at the level of individual items, rather it is derived from
percentile ranking established through plotting an infant's age to the closest week and
his or her total score on the centile graph, the percentile rankings provided on the
centile graph would be unaffected for all infants because all age differences are less
than one week.
2. The Gross Motor Function Measure (GMFM) is a clinical tool designed to evaluate the
change in gross motor function in children with disabilities. This measure consists of
88 items that evaluate lying and rolling up to walking, running and jumping skills.
There is a four-point scoring system for each item on the GMFM and can be used with
children above 6 months. In the present study, only dimensions A (lying and rolling) and
B (sitting) were used. Item scores can be summed to calculate raw and percentile scores
for each of the GMFM dimensions, selected goal areas and a total score.
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