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临床试验/NCT04770298
NCT04770298进行中(未招募)不适用

The Effectiveness of the Bobath Neurodevelopmental Treatment and Halliwick Concept Hydrotherapy in the Treatment of Children With Cerebral Palsy.

University of Thessaly2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
85
试验地点
2
主要终点
PEDI

研究概览

简要总结

Investigation of the effectiveness of water based therapy on children with Cerebral Palsy (CP)

详细描述

The purpose of this randomized controlled trial was:

To examine the effectiveness of the Halliwick concept intervention in water approach for people with motor deficiency and, more specifically, for children with diagnosed cerebral palsy.

In a second phase, to compare the contribution of water intervention to the child's motor development against just Bobath physiotherapeutic intervention, in terms of the milestones of gross motor skills of the children over time.

The aim of the research is to determine the contribution of the Halliwick Concept- Hydrotherapeutic Intervention approach in the psychomotor development in children with cerebral palsy and to explore its contribution to a comprehensive therapeutic approach for these children. It is a fact that, in recent years, parallel therapeutic approaches have gained ground, which, in combination with the physiotherapeutic treatment, contributes to the enhancement of therapeutic effects in early and follow-up intervention for children with cerebral palsy.

The study resulted from the fact that there is not such a large-scale study in Greece. Also, there are few published studies in the world, trying to evaluate the therapeutic benefit of the Halliwick Concept as an hydro-therapeutic approach.

研究设计

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

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with Cerebral Palsy
  • Not have some type of surgery or botulinum toxin infusion in the last year.
  • The children with cognitive limitations were selected, in order to be able to execute elementary commands.
  • Attending treatment program by the same therapist, either on water, or on land.

排除标准

  • Children with autism
  • Children who had some scheduled surgery or botulinum toxin injection.
  • Children with severe vision problems
  • Children who could not follow the verbal instructions or reproduce a test reproduction.
  • Children who were absent from the treatment program either in the water or on land for over a week

结局指标

主要结局

PEDI

时间窗: 9 months

PEDIATRIC EVALUATION OF DISABILITY INVENTORY (Scale for assess the daily life activities) (scoring 0%-100%)

WOTA 2

时间窗: 9 months

WATER ORIENTATION TEST ALYN 12 (Aquatic Scale to asses adaptation in water environment) ( Score 0-81)

PBS

时间窗: 9 months

PAEDIATRIC BALANCE SCALE (BERG BALANNCE SCALE MODIFIED) (Scale for assess the balance) (score 0-56)

TUG

时间窗: 9 months

TIMED UP AND GO (Scale to asses speed) (the minimoum time the better)

WOTA 1

时间窗: 9 MONTHS

WATER ORIENTATION TEST ALYN 1 (Aquatic Scale to asses adaptation in water environment) (Aquatic Score 0- 52)

HAAR

时间窗: 9 months

HUMPHRIES' ASSESSMENT OF AQUATIC READINESS (Aquatic Scale to asses adaptation in water environment)(Score 0-34)

GMFM

时间窗: 9 months

GROSS MOTOR FUNCTION MEASURE (Scale for gross mobility) (scoring 0%-100%)

SWIM

时间窗: 9 months

SWIM WITH INDEPENDENT MEASURE (Aquatic Scale to asses adaptation in water environment) (Score 0-71)

次要结局

未报告次要终点

研究者

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

Konstantinos Chandolias

Principal Investigator

University of Thessaly

研究点 (2)

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