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临床试验/NCT02882698
NCT02882698已完成不适用

Performance Analysis in Down Syndrome Through a Maze Game on Mobile Phone

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Improvement of performance

研究概览

简要总结

The game Marble Maze Classic® will be used, in which the participants have to move the mobile phone to conduct a virtual marble through a maze design. The investigators will evaluate 100 individuals (50 with Down Syndrome-DS and 50 with typical development-TD) and divide both with DS and TD into group 1 and 2, where each group consists of 25 participants, with group 2 using a maze design totally opposite to group 1.

详细描述

The game Marble Maze Classic® will be used, in which the participants have to move the mobile phone to conduct a virtual marble through a maze design. The investigators will evaluate 100 individuals (50 with Down Syndrome-DS and 50 with typical development-TD) and divide both with DS and TD into group 1 and 2, where each group consists of 25 participants, with group 2 using a maze design totally opposite to group 1.

Participants from both SD and TD will be divided into two subgroups: Group 1 (n = 50, consisting of 25 participants in TD and 25 participants in SD) and Group 2 (n = 50, consisting 25 participants in TD and 25 participants in SD), with the design of the maze for group 2 totally opposite to that of group 1 in all stages of the experiment. The use of opposite mazes is necessary to verify that the sequence of movements of the maze path does not influence performance.

To maintain the characteristics of random sampling, where each participant has an equal chance to participate in the groups, The investigators used simple probabilistic random sampling, by conducting the drawing on paper.

PROCEDURES

Individuals will be positioned comfortably in a chair set according to the size necessary, as well as a footrest, so as to stay properly positioned to enable the execution of the task.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
11 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of DS;
  • ability to perform a gripping movement to hold the mobile phone with one of the hands.

排除标准

  • presence of comorbidities such as autism or other associated genetic alterations;
  • functional disability that impedes the execution of the task or failure of task comprehension after five attempts carried out during the familiarization phase.

结局指标

主要结局

Improvement of performance

时间窗: Up to 3 months

that individuals with DS would be able to adapt to the virtual task using the mobile phone and improve performance with practice in acquisition, as well as maintain the performance in transfer tasks, namely, to change the maze.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Bandeira de Mello Monteiro

Associate Professor

University of Sao Paulo

研究点 (2)

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