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临床试验/NCT01838278
NCT01838278Unknown3 期

Effectiveness of Vojta Therapy in Motor Development of Preterm Children

Universidad de Murcia0 个研究点目标入组 120 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
3 期
入组人数
120
主要终点
Performance in Psychomotor Subscale - Bayley Scales of Infant and Toddler Development (BSID-II)

研究概览

简要总结

  • Justification: Prematurely born children have an increased prevalence of neurodevelopment problems in the first two years. Knowledge regarding the effects of early intervention programs is essential to the follow up of these children and the families.

-Hypothesis: The Vojta Therapy Model showed beneficial effects on motor development outcomes reported by Bayley Sales of Infant Development-Second Edition, in the first 18 months of life on European sample.

详细描述

Premature children constitute a heterogeneous group regarding gestational age, determinants and causes of their premature birth, illnesses that occur during the neonatal period and the socio-economic status of the family. These constraints could cause an increase in the risk of development in this group of children, as well as motor abnormalities, when compared to the population of infants born at full term.

Cerebral Palsy (CP), for example, is the most common neurological disorder in this group of children. So many studies showed the association between CP and prematurity. They have pointed out that the probability of premature infants having CP is eight times higher compared to full-term infants.

Apart from CP other minor motor abnormalities are also present in the range of consequences for the preterm children.

Therefore, if the increase is considered in children born prematurely who survive, on account of developments in neonatal care, and that the frequency of appearance of motor sequel described in them remains constant, it is of crucial importance from social, economic and health aspects to implement strategies to improve outcomes for these children. In this regard, the development of physiotherapy treatments aimed at preterm infants is essential from a prevention and intervention point of view.

At the Region of Murcia/Spain, when one child is born preterm is directed from the Neonatal Intensive Care Unit (NICU), where there has already been established a protocol for immediate referral among hospitals to early intervention services, where an interdisciplinary team develops an individualized and comprehensive intervention plan according to the characteristics and conditions of each child and, from the motor point of view, the physiotherapist team will be the one who determines the most appropriate action to be taken.

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
1 Month 至 18 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Experimental Group: First measurement had to be performed during the first trimester of life, from zero to three months corrected age or chronologically depending on the condition of the preterm or full-term infant. Not Diagnosed with any neurological damage and were receiving VT as a method of physiotherapy treatment.
  • The A control group: Consisted of premature children with similar base characteristics to the experimental group ones who did not receive VT but another method of physiotherapy treatment within a global programme of early intervention that included sensory-motor stimulation
  • The B control group: The control group B was formed by full term infants, without illnesses or risks. Seventy two boys and girls figured in this group. All children were treated and monitored by the Prevention, Promotion of Early Childhood Development and Early Intervention Service at the University of Murcia (Spain).

排除标准

  • Experimental, A and B Groups:Parents don't signed a consent form authorizing the participation of their children in this project

结局指标

主要结局

Performance in Psychomotor Subscale - Bayley Scales of Infant and Toddler Development (BSID-II)

时间窗: 30 days

Bayley-II scales, in particular with the Psychomotor Scale. The Bayley Scales of Infant and Toddler Development (BSID-II) are a set of standardized rating scales, which enable us to assess the mental, psychomotor and behavioural development of children between 1 and 42 months

次要结局

  • Performance Cognitive in Subscale of Bayley-II Scales(30 days)

研究者

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

Julio Perez-Lopez

profesor catedratico, phd

Universidad de Murcia

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