Virtual Task in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Acquisition on TouchScreen; Acquisition on Kinect; Acquisition on LeapMotion; Acquisition on TouchScreen Control Group; Acquisition on Kinect Control Group; Acquisition on LeapMotion Control Group
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.; Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.; Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.; Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.; Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.; Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; Virtual Reality Exposure Therapy; User-Computer Interface; Rehabilitation; Motor Activity