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临床试验/NCT01903616
NCT01903616已完成不适用

A Longitudinal Study of Movement and Participation in Life Activities of Young Children With Cerebral Palsy in Taiwan

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
172
试验地点
1
主要终点
Change of speech and acoustic variables in 6, 12 and 24 months

研究概览

简要总结

This study investigates the longitudinal course of developmental patterns in movement and participation in life activities (MPLA) of young children with cerebral palsy (CP) in Taiwan. Additionally, the predictors in the initial stage in determining the final developmental patterns in movement and participation in life activities MPLA of these children will be identified.

详细描述

Most researches investigated the longitudinal study of functions in adolescent or adult with CP, however, few researches investigate these functions in children with CP. Knowledge of these developmental patterns in movement and participation in life activities MPLA may be helpful in understanding, anticipating, and managing the problems of these children. We hypothesize that the course of developmental patterns in MPLA of young children with CP evolves with their age. This study investigates the longitudinal course of developmental patterns in MPLA of young children with CP in Taiwan. This study includes a validity and reliability study and a prospective longitudinal study of young children with CP over one-year. This study will be executed in 4 years and a validity and reliability study in the first year.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • diagnosis of CP

排除标准

  • presence of a progressive neurological disorder or a severe concurrent illness or disease not typically associated with CP, such as traumatic brain injury or active pneumonia

结局指标

主要结局

Change of speech and acoustic variables in 6, 12 and 24 months

时间窗: baseline, 6m, 12m, 24 m

Measurement of speech and acoustic variables

次要结局

  • Change of cerebral palsy quality of life (CPQOL) in 6, 12 and 24 months(baseline, 6m, 12m, 24 m)
  • Change of range of motion (ROM) in 6, 12 and 24 months(baseline, 6m, 12m, 24 m)
  • Change of Pediatric Berg Balance Scale (PBS) in 6, 12 and 24 months(baseline, 6m, 12m, 24 m)
  • Change of Children Assessment of Participation and Enjoyment (CAPE) in 6, 12 and 24 months(baseline, 6m, 12m, 24 m)
  • Change of spinal Alignment and Range of Motion Measure(SARROM) in 6, 12 and 24 months(baseline, 6m, 12m, 24 m)
  • Change of TNO-AZL Preschool children Quality of Life (TAPQOL)in 6, 12 and 24 months(baseline, 6m, 12m, 24 m)
  • Change of Gross motor function measure (GMFM) in 6, 12 and 24 months(baseline, 6m, 12m, 24 m)
  • Change of modified ashworth scale(MAS) in 6, 12 and 24 months(baseline, 6m, 12m, 24 m)

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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