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Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

2015年2月10日 更新者：Chang Gung Memorial Hospital

Aquatic intervention had been applied in children with neuromotor impairment for years, yet there has been little progress toward objective identifications of therapy goals, interventions, and outcomes. Thus, we attempt to design aquatic intervention activity for children with cerebral palsy to evaluate the effect of hydrotherapy.

Purpose:

To evaluate the effects of pediatric aquatic therapy on motor performance, daily activity and social participation in children with spastic cerebral palsy.

Method:

The study enrolled 27 children with spastic cerebral palsy aged from 4 to 12 years old.These children were dived into two groups: traditional rehabilitation therapy (control group), and hospital based pediatric aquatic therapy program. We evaluate the motor performance, daily activity and social participation before and after the intervention and compared the difference in improvement between groups. The measurements include modified Ashworth score, Gross Motor Function Measure (GMFM -66), Vineland Adaptive Behavior Scale (VABS) , and Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL).

Expect effect:

We suppose pediatric aquatic therapy in spastic cerebral palsy children could improve motor function and daily activity.Children could improve self-esteem and we hypothesize this could improve social participation.

研究概览

地位

完全的

条件

干预/治疗

详细说明

  • We conducted a well-designed study to investigate the effectiveness of PAT on motor function, activities of daily living (ADL),and health related quality of life(HRQOL) perspectives for children with CP.
  • A convenience sample of 27 children was recruited for the study from the outpatient clinics of the Department of Physical Medicine and Rehabilitation of two tertiary hospitals: Chang Gung Memorial Hospital and Taipei Veterans General Hospital.
  • The study was designed as a single blinded, prospective, case control study.
  • The pediatric aquatic therapy group got more improvementon motor performance measured by GMFM-66.

研究类型

介入性

注册 (实际的)

27

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 台湾
      • Taipei、台湾
        • Chang Gung Memorial Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

4年 至 12年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Children diagnosed as cerebral palsy, spastic type
  2. Gross Motor Functional Classification (GMFCS) level II-IV
  3. Age: 4-12 y/o
  4. Informed consent by parents
  5. Modified Ashworth score 2 or3
  6. If participant history of epilepsy ,well controlled by medication

Exclusion Criteria:

  1. History of psychiatric diseases
  2. Poor controlled epilepsy
  3. Received botox injection or surgery in recent three months
  4. Children diagnosed as attention deficit hyperactivity disorder(ADHD) or autism
  5. Severe mental retardation
  6. Active infection (Body temperature > 100°F)
  7. Communication problems
  8. Bowel incontinence
  9. Bladder incontinence
  10. Severe cardiovascular disease
  11. Infectious skin conditions and open wound
  12. Nasogastric tubes or gastrostomy tubes
  13. Colostomy ,urostomy or ileostomy bags
  14. Acute orthopedic injury with pain and instability
  15. Diabetes
  16. Chlorine sensitivity
  17. Latex allergies
  18. Tracheostomy

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：pediatric aquatic therapy
The children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs
程序：aquatic therapy
two hours per week, one hour per time, total 12 weeks
其他名称：
  • 物理疗法
无干预：conventional therapy
The children included in the control group continued with their original rehabilitation programs

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Unit on Gross Motor Function Measure Scale (GMFM)
大体时间：3 months
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. The score ranges from 0 to 100 and the higher represent the better gross motor function in children with cerebral palsy
3 months

次要结果测量

结果测量
措施说明
大体时间
Daily Living Subscale of Vineland Adaptive Behavior Scale
大体时间：3 months
Vineland Adaptive Behavior scale was developed by Sara et al at 1984 and was used to measure adaptive and maladaptive behavior in children age form 3-12 years-old. The daily living subscale range from 0 to 198 and the higher the score represent the better captive behavior.
3 months
Subscale on Cerebral Palsy Quality of Life Questionnaire for Children
大体时间：3months
This questionnaire was developed for Children and was a condition-specific quality of life (QOL) questionnaire for children with cerebral palsy aged 4 to 12 years. It contains social , functioning, participation , emotional ,access, pain and disability, and family health components. Participation is the main component in this study. This sub score ranges from 0 to 81 , higher scores represent better participation
3months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chang Gung Memorial Hospital

调查人员

  • 研究主任：ChiaLing Chen、Chang Gung Memorial Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年10月1日

初级完成 (实际的)

2010年7月1日

研究完成 (实际的)

2010年11月1日

研究注册日期

首次提交

2010年1月4日

首先提交符合 QC 标准的

2010年1月12日

首次发布 (估计)

2010年1月14日

研究记录更新

最后更新发布 (估计)

2015年2月11日

上次提交的符合 QC 标准的更新

2015年2月10日

最后验证

2010年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 981947B

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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