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临床试验/NCT03530982
NCT03530982Unknown不适用

Intensive Training of Functional Priorities Reported by Adolescents With Cerebral Palsy

Federal University of Minas Gerais1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年6月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Change in Daily functioning- Mobility

研究概览

简要总结

Adolescents with cerebral palsy (CP) present important limitations for the performance of daily living activities. The aims of the study is to evaluate the feasibility and effects of an intensive goal training protocol for adolescents with CP. He hypothesize that adolescents submitted to the studied protocol will present improvements in performance and satisfaction of prioritized functional goals.

详细描述

We will conduct a feasibility study to assess the implementation and the possible effects of an intensive individualized goal training with adolescents with CP. Adolescents will select up to 5 functional goals to be trained during a 2 weeks, 3 hour-daily training, totalling 30 hours across 2 weeks. Moreover, they will be asked to daily practice these activities at home along the intervention period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

The assessor will not know the aims and content of the intervention procedures.

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Medical diagnosis of bilateral CP;
  • Age between 12 and 17 years old;
  • Manual Ability Classification System (MACS) ranging from levels I to III;
  • Gross Motor Function Classification System (GMFCS) ranging from levels I to IV;
  • Ability to understand verbal instructions.

排除标准

  • Botulinum toxin or surgery in upper limbs in the previous 6 months of the study.

结局指标

主要结局

Change in Daily functioning- Mobility

时间窗: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

Pediatric Evaluation Disability Inventory (PEDI) mobility: ranging from 0-55; higher values, better outcomes

Change in Daily functioning- Self-Care

时间窗: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

Pediatric Evaluation Disability Inventory (PEDI) self-care: ranging from 0-63; higher values, better outcomes

Change in Functional Goals

时间窗: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

Canadian Occupational Performance Measure (COPM) (ranging 1-10; higher values, better outcomes)

次要结局

  • Change in Manual dexterity(1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up)
  • Change in Gross motor function(1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up)
  • Change in Participation at home(1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up)
  • Change in Participation in household activities(1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up)

研究者

发起方
Federal University of Minas Gerais
申办方类型
Other
责任方
Principal Investigator
主要研究者

MARINA B BRANDAO

Professor

Federal University of Minas Gerais

研究点 (1)

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