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临床试验/NCT00469872
NCT00469872已完成不适用

Family Centred Functional Therapy for Children With Cerebral Palsy

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)4 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2006年6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
128
试验地点
4
主要终点
activities (performance of functional tasks, motor function)

研究概览

简要总结

This study will compare two treatment approaches that are currently being used for children with cerebral palsy. Both treatments aim to improve a child's function. The two approaches being compared are: 1) improving function by working with the child to improve his/her skills and abilities ("child-focused" approach) and 2) improving function by changing/adapting the task and/or environment around the child to improve his/her skills and abilities ("context-focused" approach). It is hypothesized that the context-focused approach will significantly improve activity and participation outcomes while leading to no significant decreases in body function and structure outcomes.

详细描述

Children with cerebral palsy commonly receive ongoing physical and occupational therapy to facilitate development and to enhance functional independence in movement, self-care, play, school activities and leisure. The primary objective of this project is to conduct a multi-site clinical trial to evaluate the efficacy of a context-focused approach in improving performance of functional tasks, mobility, participation in everyday activities and quality of life in 220 children 12 months to 5 years of age who have cerebral palsy. A randomized clinical trial research design will be used to examine the efficacy of the context-focused approach compared to a child-focused approach. 72 therapists in Ontario and Alberta will be randomly assigned to provide either context-focused or child-focused therapy. Therapists in both groups will participate in a training workshop and expert consultants will be available to support the therapists throughout the study. Children will receive either the context-focused or child-focused therapy intervention for a period of 6 months. Outcomes will be evaluated at baseline, after 6 months of treatment and at a 3-month follow-up period. Outcomes will be measured across the domains of the International Classification of Functioning, Disability and Health, including body function and structure (range of motion, spinal alignment), activities (performance of functional tasks, motor function), participation (involvement in formal and informal activities), and environment (parent perceptions of care, parental empowerment). The children's range of motion will also be evaluated by an independent, trained evaluator at baseline, 3, 6, and 9 months. We hypothesize that the context-focused approach will significantly improve activity and participation outcomes while leading to no significant decreases in body function and structure outcomes.

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
None

入排标准

年龄范围
12 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children with cerebral palsy
  • children classified as levels I-V on the Gross Motor Function Classification System
  • children aged 12 months to 5 years, 11 months

排除标准

  • children whose parents feel uncomfortable or unable to respond to interviews and questionnaires in English
  • children with planned surgical or medication changes during the study period that may impact motor function
  • parents and caregivers who state that they will not be able to comply with the treatment schedule

结局指标

主要结局

activities (performance of functional tasks, motor function)

时间窗: 6 months

次要结局

  • body function and structure (range of motion)(6 months)
  • particpation(6 months)
  • parental empowerment(6 months)

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih
责任方
Principal Investigator
主要研究者

Mary Law

Professor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

研究点 (4)

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