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

NCT03227601 | Unknown DMC

• 1 other identifier: 1808
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Zika Virus

Outcome Measures

Primary Outcomes (1)

• Body Alignment

  Position or attitude of the body, the Arrangement of the parts of the body for a specific activity, or a Characteristic way of someone sustaining your body

  two-month period

Secondary Outcomes (3)

• Motor function

  two-month period

• Gastrointestinal function

  two-month period

• Muscular tonus

  two-month period

Interventions

posture adapter DEVICE

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

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50.740-545, Brazil

RECRUITING

MeSH Terms

Conditions

Zika Virus Infection

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Central Study Contacts

Labibe Mara Pinel Frederico

CONTACT

8191165364; labibep@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master's student

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 24, 2017
• Study Start: July 20, 2017
• Primary Completion: October 19, 2017
• Study Completion: August 31, 2018
• Last Updated: July 24, 2017

Record last verified: 2017-07

Locations

BR (1)