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临床试验/NCT01049581
NCT01049581已完成不适用

Effects of Pediatric Aquatic Therapy in Children With Spastic Cerebral Palsy

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2009年10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
27
试验地点
1
主要终点
Unit on Gross Motor Function Measure Scale (GMFM)

研究概览

简要总结

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.

详细描述

  • 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.

研究设计

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

入排标准

年龄范围
4 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • History of psychiatric diseases
  • Poor controlled epilepsy
  • Received botox injection or surgery in recent three months
  • Children diagnosed as attention deficit hyperactivity disorder(ADHD) or autism
  • Severe mental retardation
  • Active infection (Body temperature > 100°F)
  • Communication problems
  • Bowel incontinence
  • Bladder incontinence
  • Severe cardiovascular disease
  • Infectious skin conditions and open wound
  • Nasogastric tubes or gastrostomy tubes
  • Colostomy ,urostomy or ileostomy bags
  • Acute orthopedic injury with pain and instability
  • Chlorine sensitivity
  • Latex allergies
  • Tracheostomy

结局指标

主要结局

Unit on Gross Motor Function Measure Scale (GMFM)

时间窗: 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

次要结局

  • Daily Living Subscale of Vineland Adaptive Behavior Scale(3 months)
  • Subscale on Cerebral Palsy Quality of Life Questionnaire for Children(3months)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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