CompletedNot Applicable

Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome

Brazil12 participantsStarted 2017-06-01

Plain-language 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.

Who can participate

Age range3 Months – 24 Months

SexALL

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Inclusion Criteria: * Infants aged 3 to 24 months, diagnosed with microcephaly according to the recommendations of the Surveillance Protocol and response to the occurrence of microcephaly and / or CNS disorders, which considers head circumference less than or equal to 31.5 cm for term boys and 31.9 cm for full term girls. In cases of prematurity, the perimeter will be considered less than 2 or more standard deviations according to the Intergrowth table for gestational age and sex. Mothers should report presence of skin rash or confirmation of Zika virus infection during pregnancy. * Only children who are accompanied by a neurologist and assisted by physical therapy at least once a week will be included. Exclusion Criteria: * Children who are not taking anticonvulsant and / or antireflux medication when in the presence of seizures and gastroesophageal reflux, respectively; * Infants who have less than 3 months of botulinum toxin application; * Infants with osteomioarticular disorders, such as arthrogryposis, or other situations that impede the performance of evaluations and intervention; * Children who are already active in the aquatic environment (hot tub or hydrotherapy).

What they're measuring

change in Modified Tardieu Scale

Timeframe: baseline and up 30 minutes

Trial details

NCT IDNCT03330600

SponsorUniversidade Federal de Pernambuco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02-18