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

Primary Purpose

Zika Virus

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
posture adapter
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Zika Virus

Eligibility Criteria

12 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Federal de PernambucoRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Motor function
Ability to carry out human development stages
Gastrointestinal function
intestinal motility
Muscular tonus
basal level of muscle contraction

Full Information

First Posted
July 20, 2017
Last Updated
July 20, 2017
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT03227601
Brief Title
Effect of a Posture Adapter for 12 to 24-month Children With Zyka Virus Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
October 19, 2017 (Anticipated)
Study Completion Date
August 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zika Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
posture adapter
Intervention Description
continued use of the device at home for 2 months after instructions of how to do it
Primary Outcome Measure Information:
Title
Body Alignment
Description
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
Time Frame
two-month period
Secondary Outcome Measure Information:
Title
Motor function
Description
Ability to carry out human development stages
Time Frame
two-month period
Title
Gastrointestinal function
Description
intestinal motility
Time Frame
two-month period
Title
Muscular tonus
Description
basal level of muscle contraction
Time Frame
two-month period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Labibe Mara Pinel Frederico
Phone
8191165364
Email
labibep@gmail.com
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50.740-545
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Labibe Mara Pinel Frederico
Phone
+5581991165364
Email
labibep@gmail.com
First Name & Middle Initial & Last Name & Degree
Karla Monica Ferraz Lambertz
Phone
+558199994-1064
Email
karla_monica@hotmail.com

12. IPD Sharing Statement

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

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