Effect of a Posture Adapter for 12 to 24-month Children With Zyka Virus Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-20

Study Completion Date

2018-08-31

Brief Summary

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Congenital Zika virus syndrome (SCZv) has been gaining attention in studies due to changes in the central nervous system and in the motor development of children. These changes resulted in an unexpected picture and without future predictability, with the appearance of several functional impairments and also on orthostatic posture. In this context, the protocol of orthostatism proposed here is a 10-week program of the use of a postural adjuster, the standing frame, made of its own with alternative material to the commercial models (cardboard). The use of low cost materials allows these devices to be made in the desired size without cost high, individually adapted, easy to be transported as it is light and can still be colored. It is an equipment that offers the opportunity to experience the orthostatic posture and mainly benefits children with little economic resources that enable the acquisition of traditional devices made of iron or wood and even imported equipment. The postural adjuster allows physical and sensorial opportunity, being an auxiliary resource in standing positioning, feasible for home use, besides being useful for performing functional activities. Thus, the objective will be to analyze the repercussions of the use of the standing frame on body alignment, muscle tone, gross motor function and gastrointestinal functions of children with SCZv. An uncontrolled intervention study will be conducted with children between 12 and 24 months of age, who will undergo an evaluation before use and after the use of the adjunct along with the proposed orthostatism protocol. The postural alignment will be evaluated through photogrammetry and the evaluation of muscle tone will be performed through the modified Tardieu scale. The Gross Motor Function Measure (GMFM) scale will be used to assess the gross motor function of the children involved in the study. Questionnaires will be applied for the collection of maternal socio-demographic data, the child's data, the type and time of therapy that the child already participates, and the gastrointestinal functions. Evaluations will occur in four moments: initial / before use, on the first day of placement in the adjuster, after the first month after use and after the second month of use. For statistical analysis, the Shapiro Wilk Test will be applied to evaluate the normality of the data, and the Friedman or ANOVA tests for repeated samples, to analyze intra-group time factor for the dependent variables of each individual.

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Detailed Description

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Conditions

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Zika Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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posture adapter

continued use of the device at home for 2 months after instructions of how to do it

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* children between 12 and 24 months old;
* children with confirmed zika virus infection diagnosis;
* children with STORCH + for zika virus (blood test)

Exclusion Criteria

* children with no medication for controlling zika virus infection symptoms;
* children with musculoskeletal disorders or limitation to standing position

Minimum Eligible Age

12 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No