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Autism Spectrum DisorderNCT03254992

Real and Virtual Environments in Autism Spectrum Disorder

A study testing ASD - Abstract task, ASD - Tangible task and TD - Abstract task in people with Autism Spectrum Disorder, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
ASD - Abstract task, ASD - Tangible task and TD - Abstract task
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteBrazil
Study dates
2 Nov 2016to 20 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • need to understand the task, assessed by the ability to properly perform three attempts explanatory statement by the evaluator.

Who cannot join

  • of incomprehension.
  • no completion of the task.

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo

    São Paulo, 03828-000

Other trials in Brazil

About this study

Official title: Motor Learning Transfer Between Real and Virtual Environments in Autism Spectrum Disorder.

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.

Read the 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.

Being tested
ASD - Abstract task, ASD - Tangible task, TD - Abstract task, TD - Tangible task
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASD - Abstract taskDevice

    Experimental group using Kinect with more virtual activity.

  • ASD - Tangible taskDevice

    Experimental group using Keyboard with more real activity.

  • TD - Abstract taskDevice

    Control group using Kinect with more virtual activity.

  • TD - Tangible taskDevice

    Control group using Keyboard with more real activity.

Study groups in NCT03254992
Study groupRoleWhat they receive
ASD - Abstract taskExperimentalExperimental group using Kinect with more virtual activity.
Receives: Device: ASD - Abstract task
ASD - Tangible taskExperimentalExperimental group using Keyboard with more real activity.
Receives: Device: ASD - Tangible task
TD - Abstract taskActive comparatorControl group using Kinect with more virtual activity.
Receives: Device: TD - Abstract task
TD - Tangible taskActive comparatorControl group using Keyboard with more real activity.
Receives: Device: TD - Tangible task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2017
  2. Study start2 Nov 2016
  3. Primary completion20 Oct 2017
  4. Study completion20 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03254992
Sponsor's protocol ID
55498016.1.0000.5390
Status last verified
Nov 2017
First submitted
1 Jun 2017
Last updated
27 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing ASD - Abstract task, ASD - Tangible task and TD - Abstract task in people with Autism Spectrum Disorder, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in performance, measured by coincident timing task (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.

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