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临床试验/NCT03113630
NCT03113630已完成不适用

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

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Motor performance improvement in a virtual Timing Coincident task, comparing performance between LeapMotion, TouchScreen and Kinect.

研究概览

简要总结

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.

详细描述

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.

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
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Acquisition on Kinect

Experimental

Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.

干预措施: Acquisition on Kinect (Device)

Acquisition on LeapMotion

Experimental

Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

干预措施: Acquisition on LeapMotion (Device)

Acquisition on TouchScreen

Experimental

Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect

干预措施: Acquisition on TouchScreen (Device)

Acquisition on TouchScreen Control Group

Active Comparator

Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect

干预措施: Acquisition on TouchScreen Control Group (Device)

Acquisition on Kinect Control Group

Active Comparator

Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.

干预措施: Acquisition on Kinect Control Group (Device)

Acquisition on LeapMotion Control Group

Active Comparator

Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.

干预措施: Acquisition on LeapMotion Control Group (Device)

结局指标

主要结局

Motor performance improvement in a virtual Timing Coincident task, comparing performance between LeapMotion, TouchScreen and Kinect.

时间窗: 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

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 (1)

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