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Virtual Task in Amyotrophic Lateral Sclerosis

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Acquisition on TouchScreen
Acquisition on Kinect
Acquisition on LeapMotion
Acquisition on TouchScreen Control Group
Acquisition on Kinect Control Group
Acquisition on LeapMotion Control Group
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, Virtual Reality Exposure Therapy, User-Computer Interface, Rehabilitation, Motor Activity

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Acquisition on TouchScreen

Acquisition on Kinect

Acquisition on LeapMotion

Acquisition on TouchScreen Control Group

Acquisition on Kinect Control Group

Acquisition on LeapMotion Control Group

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 2, 2017
Last Updated
April 8, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03113630
Brief Title
Virtual Task in Amyotrophic Lateral Sclerosis
Official Title
Efficacy of Different Interaction Devices Using Virtual Task in Amyotrophic Lateral Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
August 3, 2016 (Actual)
Study Completion Date
October 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, Virtual Reality Exposure Therapy, User-Computer Interface, Rehabilitation, Motor Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acquisition on TouchScreen
Arm Type
Experimental
Arm Description
Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect
Arm Title
Acquisition on Kinect
Arm Type
Experimental
Arm Description
Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Arm Title
Acquisition on LeapMotion
Arm Type
Experimental
Arm Description
Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Arm Title
Acquisition on TouchScreen Control Group
Arm Type
Active Comparator
Arm Description
Subjects practice the task and retention TouchScreen, transfer 1 on LeapMotion and transfer 2 on Kinect
Arm Title
Acquisition on Kinect Control Group
Arm Type
Active Comparator
Arm Description
Subjects practice the task and retention Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Arm Title
Acquisition on LeapMotion Control Group
Arm Type
Active Comparator
Arm Description
Subjects practice the task and retention LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Intervention Type
Device
Intervention Name(s)
Acquisition on TouchScreen
Intervention Description
Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
Intervention Type
Device
Intervention Name(s)
Acquisition on Kinect
Intervention Description
Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Intervention Type
Device
Intervention Name(s)
Acquisition on LeapMotion
Intervention Description
Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Intervention Type
Device
Intervention Name(s)
Acquisition on TouchScreen Control Group
Intervention Description
Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
Intervention Type
Device
Intervention Name(s)
Acquisition on Kinect Control Group
Intervention Description
Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
Intervention Type
Device
Intervention Name(s)
Acquisition on LeapMotion Control Group
Intervention Description
Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
Primary Outcome Measure Information:
Title
Motor performance improvement in a virtual Timing Coincident task, comparing performance between LeapMotion, TouchScreen and Kinect.
Description
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
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos BM Monteiro, Ph.D.
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo
City
Sao Paulo
ZIP/Postal Code
03828-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30558556
Citation
Trevizan IL, Silva TD, Dawes H, Massetti T, Crocetta TB, Favero FM, Oliveira ASB, de Araujo LV, Santos ACC, de Abreu LC, Coe S, Monteiro CBM. Efficacy of different interaction devices using non-immersive virtual tasks in individuals with Amyotrophic Lateral Sclerosis: a cross-sectional randomized trial. BMC Neurol. 2018 Dec 17;18(1):209. doi: 10.1186/s12883-018-1212-3.
Results Reference
derived

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Virtual Task in Amyotrophic Lateral Sclerosis

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