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临床试验/NCT03227601
NCT03227601Unknown不适用

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

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Body Alignment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Months 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Body Alignment

时间窗: 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

次要结局

  • Motor function(two-month period)
  • Gastrointestinal function(two-month period)
  • Muscular tonus(two-month period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Labibe Mara Pinel Frederico

master's student

Universidade Federal de Pernambuco

研究点 (2)

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