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临床试验/NCT02686931
NCT02686931Unknown不适用

The Investigation of Children With Developmental Delay and Children's Rehabilitation Common Case: A Longitudinal Study

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)

研究概览

简要总结

Children with developmental disabilities and children's rehabilitation common case investigation: Long-term follow-up study.

详细描述

Three fundamental goals of early rehabilitation for children with DD are: optimizing body function within each child's prognostic potential, preventing the development of secondary conditions that impact life-long health, and promoting children's participation in their lives. Knowledge of these developmental patterns of FPLA may be helpful in understanding, anticipating, and managing the problems of these patients. The investigators hypothesize that the course of developmental patterns in Function and Participation in Life Activities (FPLA) of patients with DD evolves with their age. The levels of functional recovery included developmental function, activity, participation, and quality of life (QOL). The aim of this study is to investigate the longitudinal outcomes in patients with DD evaluated by developmental function, activity, participation, and QOL. Additionally, the predictors in the initial stage in determining the final developmental patterns in FPLA of these children will be identified.

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
— 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children with aged 0-20 years
  • Control group: Children with orthopedic disease, Experimental group: Children with Developmental disabilities

排除标准

  • Low cooperative with follow-up
  • Low cooperative with clinical assessment
  • Low cooperative with questionnaire writing and data collection

结局指标

主要结局

Change of Comprehensive Developmental Inventory for Infants and Toddlers(CDIIT)

时间窗: baseline, six months and one year

Measurement of CDIIT

次要结局

  • Change of Pediatric Balance Scale(PBS)(baseline, six months and one year)
  • Change of Gross Motor Function Measure, 66 items,(GMFM-66)(baseline, six months and one year)
  • Change of Modified Ashworth Scale (MAS)(baseline, six months and one year)
  • Change of Spinal Alignment and Range of Motion Measure (SAROMM)(baseline, six months and one year)
  • Change of Chinese Child Developmental Inventory (CCDI)(baseline, six months and one year)
  • Change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-II)(baseline, six months and one year)
  • Change of Quality of upper extremity skills test(QUEST)(baseline, six months and one year)
  • Change of Peabody Developmental Motor Scales-2nd Edition(PDMS-II)(baseline, six months and one year)

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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