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Zika VirusNCT03227601

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

A study testing posture adapter in people with Zika Virus, run by Universidade Federal de Pernambuco at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 12 to 24 months
Conditions the study is for
Zika Virus
What is being tested?
posture adapter
Type of treatment
Medical device
How many people
20 participants
Where
1 siteBrazil
Study dates
20 Jul 2017to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 24 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Labibe Mara Pinel Frederico contact

8191165364

labibep@gmail.com

Brazil1 site, 1 recruiting
  • Universidade Federal de Pernambuco

    Recife, Pernambuco, 50.740-545

    Labibe Mara Pinel Frederico, +5581991165364, labibep@gmail.com

    Karla Monica Ferraz Lambertz, +558199994-1064, karla_monica@hotmail.com

    Recruiting

Other trials in Brazil

About this study

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

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
Being tested
posture adapter
Medical subject headings
Zika Virus Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • posture adapterDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: two-month period

Secondary outcomes (3)
  1. Motor function

    Ability to carry out human development stages

    Measured: two-month period

  2. Gastrointestinal function

    intestinal motility

    Measured: two-month period

  3. Muscular tonus

    basal level of muscle contraction

    Measured: two-month period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2017
  2. Study start20 Jul 2017
  3. Primary completion19 Oct 2017 (estimated)
  4. Study completion31 Aug 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03227601
Sponsor's protocol ID
1808
Status last verified
Jul 2017
First submitted
20 Jul 2017
Last updated
24 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing posture adapter in people with Zika Virus, run by Universidade Federal de Pernambuco at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Labibe Mara Pinel Frederico (8191165364, labibep@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Alignment (time frame: two-month period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.

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