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临床试验/NCT04351464
NCT04351464已完成不适用

Is Reflexology Applied to Children With Cerebral Palsy an Effective Method?

Kırıkkale University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2014年1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
40
试验地点
2
主要终点
physiological parameter

研究概览

简要总结

Objectives: This study was planned to investigate the influence of reflexology applied to children with cerebral palsy together with physical therapy program involving neurodevelopmental approaches.

Methods: The study involved 40 children aged,16 girls and 24 boys between 3 and 15 years and divided into two groups. While the children in Group 1 were given twice a week for eight weeks neurodevelopmental treatment, reflexology was applied to those in Group 2 together with neurodevelopmental treatment. Drooling Severity and Frequency Scale, Pediatric Sleep Questionnaire and the Children's Health Questionnaire was used to assess the drooling, status of sleep and quality of life in children.

详细描述

The study involved a total of 40 children aged between three and 15 diagnosed with CP by a pediatric neurologist. Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study. However, those children were excluded who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children at levels 3/4/5 of the GMFCS who did not have any open wounds on the foot, where the application was to be performed, and whose parents consented to the child's participation were accepted in the study.

排除标准

  • who were treated with botulinum toxin in the last six months, underwent surgery, were treated with reflexology or any other alternative medicine method and who had refractory epilepsy.

结局指标

主要结局

physiological parameter

时间窗: 8 weeks

Drooling frequency and severity of drooling

Questionnaire about Sleep status

时间窗: 8 weeks

Assess the problems related to sleep

Questionnaire about Quality of life of children

时间窗: 8 weeks

general health, physical condition, global behavior, mental health, self-esteem and the effect of time on parents

次要结局

  • Physical parameter(8 weeks)

研究者

发起方
Kırıkkale University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabiha BEZGİN

PhD, Physical Therapist

Kırıkkale University

研究点 (2)

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