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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03227601
Recruitment Status : Unknown
Verified July 2017 by Labibe Mara Pinel Frederico, Universidade Federal de Pernambuco.
Recruitment status was:  Recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Information provided by (Responsible Party):
Labibe Mara Pinel Frederico, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
Zika Virus Device: posture adapter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : October 19, 2017
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Body Alignment [ Time Frame: two-month period ]
    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

Secondary Outcome Measures :
  1. Motor function [ Time Frame: two-month period ]
    Ability to carry out human development stages

  2. Gastrointestinal function [ Time Frame: two-month period ]
    intestinal motility

  3. Muscular tonus [ Time Frame: two-month period ]
    basal level of muscle contraction

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03227601

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Contact: Labibe Mara Pinel Frederico 8191165364

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Universidade Federal de Pernambuco Recruiting
Recife, Pernambuco, Brazil, 50.740-545
Contact: Labibe Mara Pinel Frederico    +5581991165364   
Contact: Karla Monica Ferraz Lambertz    +558199994-1064   
Sponsors and Collaborators
Universidade Federal de Pernambuco
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Responsible Party: Labibe Mara Pinel Frederico, master's student, Universidade Federal de Pernambuco Identifier: NCT03227601    
Other Study ID Numbers: 1808
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Zika Virus Infection
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections