NCT03330600

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

Completed NA Last updated 7 May 2019

What this trial tests

NA trial testing aquatic physicotherapy in Zika Virus Infection in 12 participants. Completed in 30 October 2018.

Timeline

1 June 2017

Primary endpoint
18 February 2018

30 October 2018

Quick facts

Lead sponsor	Universidade Federal de Pernambuco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	12
Start date	1 June 2017
Primary completion	18 February 2018
Estimated completion	30 October 2018
Sites	1 location across Brazil

Drugs / interventions tested

• aquatic physicotherapy
• immersion

Conditions studied

• Zika Virus Infection — all drugs for Zika Virus Infection →
• Microcephaly — all drugs for Microcephaly →

Sponsor

Universidade Federal de Pernambuco — full company profile →

Who can join

Adults 3 Months to 24 Months, any sex, with Zika Virus Infection or Microcephaly. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.