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Virtual Task in Amyotrophic Lateral Sclerosis

2017年4月8日 更新者:Carlos Bandeira de Mello Monteiro、University of Sao Paulo

Efficacy of Different Interaction Devices Using Virtual Task in Amyotrophic Lateral Sclerosis

Thirty individuals with ALS (18 men and 12 women, mean age 59 years, range 44-74 years), and 30 healthy controls matched for age and gender, participated. Individuals with ALS and from the control group were randomly divided into three groups, each using a different communication device systems (Kinect®, Leap Motion Controller® or touchscreen) to perform two task phases (acquisition and retention). Performance was then explored in a third phase (transfer) by switching devices (two transfers); so that, all groups had contact with all communication interfaces.

研究概览

详细说明

Participants A total of 60 individuals participated in this study, 30 individuals with ALS (18 men and 12 women, mean age 59 years, range 44-74 years) and 30 healthy individuals who formed the control group, which were (equally) matched individually for age and gender with ALS group.

Rating scales For clinical characteristics of the participants, the scales of functional assessment, fatigue and quality of life were applied. As a functional assessment tool, the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS - R) was used, validated in Brazilian individuals with ALS which allows monitoring of symptoms and limitations of daily living activities. To evaluate fatigue during the execution of tasks, were used the Fatigue Severity Scale (FSS) and for the assessment of quality of life, were used the Amyotrophic Lateral Sclerosis Assessment Questionnaire in the Portuguese Language (ALSAQ-40/BR), which is also validated for the Brazilian population with ALS.

Protocol Subjects were randomly divided into three groups, using different interfaces for the acquisition of movement. The description of the task and the RV interfaces that were used are described as follows.

Task Participants performed a task to test communication devices developed by the Information Systems Team at the University of São Paulo. The task was set up as a game in which the goal was to reach as many bubbles displayed on an 11-inch computer monitor, forming seven rows and 18 columns with a total of 126 bubbles. This required individuals to be able to use a range as is typically required in communication systems. The task was divided into two phases: (1) the first phase was characterized by identification of dexterity zone or range of reach, in which the subject had to touch ("burst") the largest possible number of bubbles (changing bubble color from blue to gray) in a set time of 30 seconds, identifying the range zone; (2) the second phase was characterized as the persecution stage, at this time the researcher defined a central bubble (usually chosen in the center of the skill area, on the bottom line), which changed the color to red. From this moment the individual pursued random bubbles that appeared in their range zone, alternating with a return to the central bubble. This phase was carried out for 30 seconds. To motivate, the task randomly provided bubbles outside the range zone and generated a greater challenge to the individual. The software generated information of the coordinates x, y (row and column) where the bubble was touched and the time the bubble was touched. During task execution, the participant received feedback of the number of bubbles touched, the remaining playing time and the total number of points obtained in attempts, thus observing the performance of the participants.

Interfaces To perform the task were used 3 different interfaces: two interfaces without physical contact, being the Kinect® for Windows from Microsoft, composed of a traditional RGB camera and an infrared depth sensor (IR) and LMC®, characterized as a small motion sensor that demonstrated robustness to measure the movements of the hand and fingers. The interface with physical contact, the touchscreen, was the computer screen itself, where individuals touched the screen in order to burst the bubbles, performing the task. It is noteworthy that the touchscreen is a sensitive interface, employed through pressure, created in order to interact with digital information, found in a majority of modern consumer electronics, mainly computers, tablets and mobile phones.

Procedures and design Individuals who participated in the study gave written informed consent and then were sent to a reserved and quiet room to perform the tasks only in the presence of the researcher. The computer monitor was positioned on a table in front of the participants. The chair was adjusted in accordance with the size and need of the individual, with a footrest available if needed. For wheelchair users, their own wheelchair was used. After the necessary adjustments to perform the task, questionnaires and functional assessment scales were applied; then the researcher provided verbal instructions and performed a demonstration of interfaces according to each task (Kinect® for Windows, LMC® or touchscreen). Subjects were instructed to use the dominant hand (i.e., the least affected side) for all interfaces used during the game.

For the acquisition phase a target was set of 300 bubbles to be touched in the definition phase of the dexterity zone. There were 126 bubbles presented during each attempt; therefore it took at least three attempts to reach the proposed goal. Soon after the step establishing the dexterity zone, the researcher defined the central bubble and began the stage of chase area. In addition to the acquisition phase, all groups performed a retention test after 5 minutes with the completion of only one attempt. After the retention test, two transfer tests with the change of interfaces were performed.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Sao Paulo、巴西、03828-000
        • Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 75年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • individuals diagnosed with ALS defined according to the revised classification of El Escorial;
  • individuals who regularly attended the Neuromuscular Disease Research Sector (SIDNM) of the Federal University of São Paulo

Exclusion Criteria:

  • individuals who had other diagnosis of neuromuscular disease such as: progressive muscular atrophy (PMA), progressive bulbar paralysis (PBP), primary lateral sclerosis (PLS);
  • individuals associated with other neurodegenerative diseases;
  • those presenting established functional disability that would prevent the completion of the task.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:在触摸屏上采集
受试者练习任务并保留触摸屏,在 LeapMotion 上传输 1,在 Kinect 上传输 2
参与者在触摸屏上执行获取和保留,在 Kinect 上传输 1,在 LeapMotion 上传输 2。
实验性的:在 Kinect 上获得
受试者练习任务并保留 Kinect,在触摸屏上传输 1,在 LeapMotion 上传输 2。
参与者在 Kinect 上执行获取和保留,在触摸屏上传输 1,在 LeapMotion 上传输 2。
实验性的:收购 LeapMotion
受试者练习任务并保留 LeapMotion,在触摸屏上传输 1,在 Kinect 上传输 2。
参与者在 LeapMotion 上执行获取和保留,在触摸屏上传输 1,在 Kinect 上传输 2。
有源比较器:收购触摸屏控制组
受试者练习任务并保留触摸屏,在 LeapMotion 上传输 1,在 Kinect 上传输 2
Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
有源比较器:收购 Kinect Control Group
受试者练习任务并保留 Kinect,在触摸屏上传输 1,在 LeapMotion 上传输 2。
Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
有源比较器:收购 LeapMotion Control Group
受试者练习任务并保留 LeapMotion,在触摸屏上传输 1,在 Kinect 上传输 2。
Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Motor performance improvement in a virtual Timing Coincident task, comparing performance between LeapMotion, TouchScreen and Kinect.
大体时间:3 months
Analysis of the motor performance using a virtual Coincident timing task in different devices to compare wether a task with or without contact promote better performance for people with Amyotrophic Lateral Sclerosis
3 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Carlos BM Monteiro, Ph.D.、University of Sao Paulo

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年2月2日

初级完成 (实际的)

2016年8月3日

研究完成 (实际的)

2016年10月4日

研究注册日期

首次提交

2017年4月2日

首先提交符合 QC 标准的

2017年4月8日

首次发布 (实际的)

2017年4月13日

研究记录更新

最后更新发布 (实际的)

2017年4月13日

上次提交的符合 QC 标准的更新

2017年4月8日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

在触摸屏上采集的临床试验

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