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临床试验/NCT05190029
NCT05190029已完成不适用

Early Craniosacral and Primitive Reflex Assessment in Infant Neurodevelopment.

Clinica Gema Leon1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Series of questions to the children's parents

研究概览

简要总结

Question(s): Can active primitive reflexes (APR) and cranial blocks (CB) in healthy children interfere with neurological balance causing psycho-behavioral and cognitive dysfunctions? Design: Cross-sectional and descriptive study analyzing perinatal, neurobehavioral and physiotherapeutic parameters. Participants: School population of both genders (n=120) divided in two groups: 3-6 years old (n=60) and 6-8 years old (n=60). Intervention: Systematic evaluation of the children based on a parent survey, assessment by teachers and physiotherapeutic exploration. Outcome measures: Perinatal (surveyed parents) and neurobehavioral problems (assessed by teachers) were related to the presence of RPA and BC (analyzed by physiotherapeutic exploration).

Key words: primitive reflexes, craniosacral disfunctions, neurodevelopment, childhood, early diagnosis, screening.

详细描述

Primitive reflexes (PR) are indispensable for the survival of the individual in the early stages of life. PR are necessary for a coordinated response to sensory stimuli during the period of cortical immaturity until the maturation of the central nervous system (CNS). However, PR must be gradually abolished as the subject's development proceeds, allowing for voluntary and functional movement responses. This process of PR abolition is due to the synaptic plasticity of the CNS. Persistent ROP can be identified by means of a systematic neurological examination. On the other hand, through craniosacral exploration, blockages in the craniosacral system can be evidenced; under physiological conditions, this system seeks to balance the mobility of membranes and cranial sutures, based on the coordinated movement of the cranial bones and the sacrum. If neurological homeostasis is disturbed in the child after diagnosing possible BC, this could manifest in the persistence of RPA and/or vice versa.

Observation of the child's different behavioral patterns in social and emotional areas, as well as his or her physical and psychological capacities, could help to detect early possible alterations in the onset of neurodevelopment. Such detection is essential for the health professional to be able to establish an appropriate treatment.

The aim of this study is to detect early infant neurodevelopmental dysfunctions and their possible relationship with RPA and/or BC in apparently healthy children.

Therefore, the research questions of this study were:

  1. Are RPA and/or BC related to child neurodevelopmental disturbances?
  2. In relation to the previous question, by means of the systematic evaluation of RPA and BC could children with neurodevelopmental disorders be identified in order to treat them early?

研究设计

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

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Apparently healthy children
  • •School group
  • •Within age range

排除标准

  • •Children with possible pathologies
  • •Older than the established age

研究组 & 干预措施

Complete sample

Experimental

Group of 120 children evaluated by craniosacral therapy for cranial blocks and primitive reflexes.

干预措施: Series of questions to parents of children in a virtual form. (Diagnostic Test)

Complete sample

Experimental

Group of 120 children evaluated by craniosacral therapy for cranial blocks and primitive reflexes.

干预措施: Intervention by teachers (Other)

Complete sample

Experimental

Group of 120 children evaluated by craniosacral therapy for cranial blocks and primitive reflexes.

干预措施: Physiotherapeutic evaluation (Procedure)

结局指标

主要结局

Series of questions to the children's parents

时间窗: one week

A questionnaire of 5 questions in an online format was sent to the parents or legal representatives of each child related to behavioral, psychomotor and cognitive aspects, pregnancy and childbirth.

Teachers' test by means of the "Battelle Development Inventory" (BDI).

时间窗: Three weeks

The school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which assesses five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-50%), normal (50-80%) and high (80-100%). Low and high values are considered impairments in one or more of the evaluated areas.

次要结局

  • Craniosacral evaluation of active primitive reflexes.(Three weeks)
  • Craniosacral evaluation of possible cranial blocks(Three weeks)

研究者

发起方
Clinica Gema Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

GEMA LEÓN BRAVO

Principal Investigator

Clinica Gema Leon

研究点 (1)

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