Zika Virus Infection Clinical Trial
Official title:
Efficacy of Aquatic Physiotherapy in Stress Level and Muscle Tone of Children Between 3 and 24 Months With Microcephaly by Zika Virus Congenital Syndrome
Microcephaly associated with Congenital Syndrome of the Zika virus (SCVZ) was highlighted due to atypical structural and behavioral changes of the central nervous system. Such changes contribute to the appearance of functional impairments and difficulties of adaptation of the child to the necessary therapeutic follow-up. In this context, the search for adjuvant therapies that allow better management of these alterations has grown and, given its advantages, aquatic physiotherapy may be an auxiliary resource in the care of this population. The aquatic environment is capable of promoting a state of relaxation that, when associated with a kinesiotherapy protocol, is believed to have this potentiated effect. Thus, our objective will be to evaluate the efficacy of aquatic physiotherapy on the level of stress and muscle tone in children with microcephaly associated with SCVZ. A crossover, randomized, controlled and blind study will be carried out with children between 3 and 24 months of age, who will undergo two interventions: aquatic physiotherapy and water immersion. The evaluation of muscle tone will be performed through the Tardieu scale before and after the intervention; the physiological parameters (heart and respiratory rate, oxygen saturation and temperature) and the stress level will be evaluated before, immediately after and 30 minutes after the intervention. In addition, questionnaires will assess the child's behavioral state, level of irritation and sleep characteristics. For data normalization the Shapiro Wilk Test will be applied; the percentage values and relative frequency will be used for the descriptive analysis and for the numerical variables the values of mean and standard deviation or median and interquartile range. The paired T and ANOVA tests for repeated samples will be applied, which will analyze the intra-group time factor for the dependent variables of each individual. And for intergroup analysis, the variables may be submitted to the T-Test for independent or Mann-Whitney samples.
A randomized, controlled, blind crossover study will be conducted at the Laboratory of
Pediatric Studies (LEPED) located in the Physiotherapy Department of the Federal University
of Pernambuco (UFPE), from January 2017 to November 2017. The study will be composed infants
diagnosed with microcephaly associated with Zika virus Syndrome of the state of Pernambuco
(PE), recruited for convenience of both sexes, aged 3 to 24 months of life.
Initially randomization of these children will be performed through randomization.com. and
allocation in two groups (experimental and control) for the first session. After a period of
one week (washout period), the groups are reversed so that everyone receives both
interventions. Children in the experimental group will be submitted to a session of aquatic
physiotherapy and the group control the immersion in water, described later. The study will
be composed of two main researchers, the researcher 1 responsible for the intervention and
the researcher 2 responsible for the evaluations, who will be blind to the intervention.
The collection of the clinical and sociodemographic data of the responsible person and the
child will be done through the evaluation form developed for the research. Before the
intervention, the child and the caregiver will be accommodated in a room with temperature,
luminosity and controlled noises so that they can rest and thus minimize the effects of the
route to the place of data collection. The evaluation begins with the assessment of muscle
tone of the upper limbs and lower limbs, physiological parameters, postaral evaluation and
application of questionnaires about maternal perception about the behavior of the and the
level of stress. Immediately after the intervention will be reassessed muscle tone,
physiological parameters and applied a questionnaire of maternal satisfaction about the
therapy applied and perception of stress level.
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