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临床试验/NCT05002504
NCT05002504已完成不适用

Craniosacral Therapy as a Neurodevelopmental Correction for the Improvement of Children's Balance and Coordination.

Clinica Gema Leon2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
"Series of questions to the children's parents"

研究概览

简要总结

Coordination and balance are manifested as motor skills or abilities that are acquired as the Central Nervous System develops. In the infant stage, these qualities help guide specialists to recognize possible abnormalities that at first glance seem banal, but that, as time goes by, acquire greater difficulty, causing even more complex problems in the long term. Craniosacral therapy could help these skills to be correctly established during growth, correcting such impairment in time during neurodevelopment. Objective: To correct possible alterations that occur during infant growth related to balance and coordination in neurodevelopment, by means of craniosacral therapy compared with the specific therapy of balance and coordination usually used in pathologies diagnosed of this caliber. Design: Longitudinal-experimental study with a population of 86 apparently healthy children. Setting/Participants: 86 children were treated without excluding sex and divided into three groups: placebo group (n=25), craniosacral therapy group (n=30) and balance and coordination therapy group (n=31). Interventions: group 1 (placebo), group 2 (craniosacral therapy) group 3 (balance and coordination therapy). Results: The Battelle scale prior to the therapies developed in the study showed balance and coordination imbalances in the participants of the three groups, with lower percentages in the placebo treatment. Sessions from the 2nd to the 7th of treatment show increasing percentages and fluctuating for craniosacral therapy between 51% to 56% and 100% satisfaction, significantly valued. As for balance and coordination therapy, satisfaction percentages are evident only in the 6th and 7th sessions, with statistically significant values. Finally, the Battelle post-therapy assessment scale shows a higher number of participants in the percentages classified as normal (50-80%) in the craniosacral therapy group, improving the evaluated parameters with statistically significant values. Conclusion: The study shows that craniosacral therapy can not only act as a treatment for the improvement of children's balance and coordination, but also helps small corrections during children's neurodevelopment, avoiding the evolution of pathologies in the long term. It is therefore necessary for a more prompt, total and lasting correction of these skills in the infant.

详细描述

Design:

A longitudinal-experimental study was carried out with a child population of 86 children aged 6 to 8 years old without excluding sex in a school group in Cordoba (Spain).

Participants:

Eighty-six apparently healthy children between 6 and 8 years of age were treated as prevention in balance and coordination motor skills at the Gema León physiotherapy clinic in Córdoba (Spain). The children were divided into three groups: 25 patients in the placebo group (group 1), 30 patients in the craniosacral therapy group (group 2) and 31 patients in the balance and coordination therapy group (group 3).

Primary outcome: A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children. On the other hand, the school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which evaluates 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 (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Patients will not know whether they will be treated or given a placebo.

入排标准

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

入选标准

  • healthy children
  • aged 6 to 8 years old
  • school group

排除标准

  • unhealthy children
  • ages outside the 6-8 age range

结局指标

主要结局

"Series of questions to the children's parents"

时间窗: two weeks

A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children

"Battelle Developmental Inventory" (BDI)

时间窗: two weeks

On the other hand, the school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which evaluates 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 (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated

次要结局

  • "The effectiveness values of the therapies for each group"(seven weeks)
  • "Pre-treatment Battelle Scale"(two weeks)
  • "percentages of satisfaction from 1st to the 7th therapy sessions"(seven weeks)
  • "Number of participants in each therapy group"(Seven weeks)
  • "Post-treatment Battelle Scale"(two 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 (2)

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