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临床试验/NCT00465686
NCT00465686已完成1 期

Ergonomic Classroom Furniture and the Printing Legibility of Elementary School Students With CP

Holland Bloorview Kids Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年2月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Minnesota Handwriting Assessment

研究概览

简要总结

The purpose of this pilot study is to gather the data needed to do a larger research study to determine whether children with cerebral palsy print better sitting at an ergonomically-designed, custom-fitted school desk or at an oversized, standard school desk.

详细描述

This pilot study will allow us to gather information for a high-quality randomized controlled trial to study the efficacy of ergonomic school furniture as a remedial handwriting intervention for young students with cerebral palsy. We will conduct the study in two parts. In the first part, 30 children with Gross Motor Function Classification System (GMFCS) Level I and II cerebral palsy will each provide manuscript handwriting samples using two different school furniture configurations. A blinded assessor will score the legibility of handwriting samples using the Minnesota Handwriting Assessment (MHA) as a primary outcome measure. In the second part, seven occupational therapy experts will attend a focus group to help us determine the minimal clinically important difference score for the MHA. We will use the data collected to determine the sample size requirements for a proposed randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • primary diagnosis of cerebral palsy
  • functional status of Gross Motor Function Classification System Level I or II

排除标准

  • genetic disorder;
  • attention-deficit hyperactivity disorder; or,
  • pervasive developmental disorder

结局指标

主要结局

Minnesota Handwriting Assessment

时间窗: 5-10 minutes

次要结局

未报告次要终点

研究者

研究点 (2)

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