Real and Virtual Environments in Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
ASD - Abstract task
ASD - Tangible task
TD - Abstract task
TD - Tangible task
Sponsored by
About this trial
This is an interventional supportive care trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- need to understand the task, assessed by the ability to properly perform three attempts explanatory statement by the evaluator.
Exclusion Criteria:
- of incomprehension.
- no 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 Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
ASD - Abstract task
ASD - Tangible task
TD - Abstract task
TD - Tangible task
Arm Description
Experimental group using Kinect with more virtual activity.
Experimental group using Keyboard with more real activity.
Control group using Kinect with more virtual activity.
Control group using Keyboard with more real activity.
Outcomes
Primary Outcome Measures
Change in performance, measured by coincident timing task
The participants who will perform the abstract task first, will present decrease on performance, measured by the coincident timing task.
Secondary Outcome Measures
Full Information
NCT ID
NCT03254992
First Posted
June 1, 2017
Last Updated
November 22, 2017
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03254992
Brief Title
Real and Virtual Environments in Autism Spectrum Disorder
Official Title
Motor Learning Transfer Between Real and Virtual Environments in Autism Spectrum Disorder.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
November 2, 2016 (Actual)
Primary Completion Date
October 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (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
Individuals with Autism Spectrum Disorder (ASD) are known to have difficulty with socio-communicative functioning and restricted or repetitive behaviors or interests, and there is considerable evidence that the majority also struggle with associated emotional problems. Speech is typically delayed or may regress, comprehension is impaired, if not at the word level, then at the level of sentences, nonverbal and verbal language are affected, and pretend play is delayed or absent, some children are nonverbal or have sparse, impoverished, poorly articulated, and grammatical speech. Objective: To assess in which interface has ASD best performance or functionality. Method: Will be evaluated 100 individuals divided into two groups: 50 individuals with diagnosis of Autistic Spectrum Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50 individuals with typical development (TD-group) matched by age and sex to the ASD-group. Individuals with comorbidities and functional disabilities that would impede the completion of the task were excluded.
Detailed Description
Will be evaluated 100 individuals divided into two groups: 50 individuals with diagnosis of Autistic Spectrum Disorder (ASD-group), aged 7 to 15 years old, males and females; and 50 individuals with typical development (TD-group) matched by age and sex to the ASD-group. The ASD-group will be recruited from GAPI - Special Education in São Bernardo do Campo, São Paulo, Brazil, which is a school for children and adolescents with pervasive developmental disorders.
For a diagnosis of ASD, apart from qualitative alterations in social communication and interaction (criterion A) in addition to stereotyped, repetitive, restricted behavior patterns (criterion B), that present in the early developmental period (criterion C), it is also required that these "symptoms cause clinically significant impairment in social, occupational and other important areas of current functioning" (criterion D), and that they are not better explained otherwise (criterion E). Given this information these items will be taken into consideration and the group was well evaluated.
With the purpose to homogenize the sample, will be only included ASD with the 1st level to 5th education to grade elementary.
Instrument For data collection will be used a gaming software created in partnership with the Information Systems group of School of Arts, Sciences and Humanities, EACH-USP.
The game offers task of "Timing" Coincident, which when executed are displayed on the computer screen 10 balls accessing (red light) in sequence until the last ball, which is considered the target (green light). The participant can have immediate feedback of hit or task error by different sounds (Auditory Interaction) and through visual images (Visual Interaction) that change colors, that will be previously shown to him.
Task Coincident Timing In the more tangible button-press task, the individuals will be required to 'intercept' a falling virtual object at the moment it reached the interception point by pressing a button on the computer's keyboard. In the more abstract, less tangible task, they were instructed to 'intercept' the virtual object by making a hand movement (i.e., a waving gesture) in a virtual environment.
The magnitude and direction of each participant's error in anticipating the light's "arrival" at the end of the runway, in milliseconds, is recorded by the game.
Objective the game is to evaluate the difference in time between the participant's execution of the response and the arrival of the object at the target location, overall temporal accuracy, and hence coincidence-anticipation timing skill.
The software provides a "user login" for each research participant, where the following data are stored: Participant name; Date of birth; sex; Pathology type; Researcher name.
Procedures The participants will be positioned comfortably in a chair adjusted according to size and needs along with a footrest so that they will be positioned properly to enable task execution. Before starting the task, the operation of the game will be verbally explained and a demonstration will be offered by the examiner. Runtime will be noted in each experimental stage, as explained below: acquisition (A), retention (R), and transfer (T).
All participants made 20 trial acquisitions, 5 retention trials after 5 minutes with no contact with the task and 5 transfer trials immediately after retention trials. Thus, each participant will have 30 trials. During acquisition and retention trials, the bubbles simulate a dropped light movement with 0.5 seconds between each bubble and 5 seconds between the first and last bubble.
The subjects will perform alternating interfaces for the same task, Kinect for Windows (gesture task with virtual environments), Keyboard (button press with tangible environments), and both groups will carry out the transfer phase on Touch Screen interface. The subjects of each group (ASD and TD) will be divided into 2 groups, group A and group B, according to the order of interfaces to carry out the task; Group A will perform the abstract task (kinect with more virtual activity) and then the tangible task (keyboard with more real activity), and the group B, will perform the reverse process.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASD - Abstract task
Arm Type
Experimental
Arm Description
Experimental group using Kinect with more virtual activity.
Arm Title
ASD - Tangible task
Arm Type
Experimental
Arm Description
Experimental group using Keyboard with more real activity.
Arm Title
TD - Abstract task
Arm Type
Active Comparator
Arm Description
Control group using Kinect with more virtual activity.
Arm Title
TD - Tangible task
Arm Type
Active Comparator
Arm Description
Control group using Keyboard with more real activity.
Intervention Type
Device
Intervention Name(s)
ASD - Abstract task
Intervention Description
Experimental group using Kinect with more virtual activity.
Intervention Type
Device
Intervention Name(s)
ASD - Tangible task
Intervention Description
Experimental group using Keyboard with more real activity.
Intervention Type
Device
Intervention Name(s)
TD - Abstract task
Intervention Description
Control group using Kinect with more virtual activity.
Intervention Type
Device
Intervention Name(s)
TD - Tangible task
Intervention Description
Control group using Keyboard with more real activity.
Primary Outcome Measure Information:
Title
Change in performance, measured by coincident timing task
Description
The participants who will perform the abstract task first, will present decrease on performance, measured by the coincident timing task.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
need to understand the task, assessed by the ability to properly perform three attempts explanatory statement by the evaluator.
Exclusion Criteria:
of incomprehension.
no 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
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Real and Virtual Environments in Autism Spectrum Disorder
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