Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome
Condition: Zika Virus Infection; Microcephaly
MeSH terms: Zika Virus Infection; Microcephaly
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): aquatic physicotherapy; immersion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Aquatic physiotherapy will be performed in a bathtub with water heated to a temperature around 37º C and environment with adequate temperature and luminosity. Kinesiotherapy will begin with smooth sliding movements in the aquatic environment, still in flexor restraint, allowing the child to adapt to the temperature of the new environment; joint mobilizations will be initiated on the shoulders and hips followed by stretching of the accessory muscles of the breath, spine erector, flexor and extensors of shoulder, elbow, hip, knee and ankle. The sessions will last 10 minutes and may be interrupted if the child shows signs of discomfort such as cyanosis, increased respiratory rate, bronchoaspiration or does not adapt to the environment, ie, remain crying for more than 5 minutes.; The immersion will be performed in a bathtub with water heated to a temperature around 37º C and environment with adequate temperature and luminosity. The therapy will begin with smooth sliding movements in the aquatic environment, still in flexor restraint, allowing the child to adapt to the temperature of the new environment. The sessions will last 10 minutes and may be interrupted if the child shows signs of discomfort such as cyanosis, increased respiratory rate, bronchoaspiration or does not adapt to the environment, ie, remain crying for more than 5 minutes.
Other intervention name(s): hydrotherapy; hydrotherapy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment