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

Zika Virus Clinical Trial

Official title:

Effect of a Posture Adapter Use on Body Alignment in Standing Position on Children Between 12 and 24 Months Old With Zyka Virys Congenital Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03227601
• Other study ID #: 1808
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2017
• Last updated: July 20, 2017
• Start date: July 20, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2017
• Source: Universidade Federal de Pernambuco
• Contact: Labibe Mara Pinel Frederico
• Phone: 8191165364
• Email: labibep[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2018
• Est. primary completion date: October 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Zika Virus

Intervention

Device:
• posture adapter
continued use of the device at home for 2 months after instructions of how to do it

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Motor function	Ability to carry out human development stages	two-month period
Secondary	Gastrointestinal function	intestinal motility	two-month period
Secondary	Muscular tonus	basal level of muscle contraction	two-month period