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.
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
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.
- Conditions
- Autism Spectrum Disorder
- 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 group | Role | What they receive |
|---|---|---|
| ASD - Abstract task | Experimental | Experimental group using Kinect with more virtual activity. Receives: Device: ASD - Abstract task |
| ASD - Tangible task | Experimental | Experimental group using Keyboard with more real activity. Receives: Device: ASD - Tangible task |
| TD - Abstract task | Active comparator | Control group using Kinect with more virtual activity. Receives: Device: TD - Abstract task |
| TD - Tangible task | Active comparator | Control 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.
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.
- First posted21 Aug 2017
- Study start2 Nov 2016
- Primary completion20 Oct 2017
- Study completion20 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos BM Monteiro, Ph.D., Principal investigator, University of Sao Paulo
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Learning Transfer Between Real and Virtual Environments in Autism Spectrum Disorder.
- ClinicalTrials.gov ID
- NCT03254992
- Acronym / sponsor ID
- 55498016.1.0000.5390
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASD - Abstract task | Experimental | Device: ASD - Abstract taskExperimental group using Kinect with more virtual activity. |
| ASD - Tangible task | Experimental | Device: ASD - Tangible taskExperimental group using Keyboard with more real activity. |
| TD - Abstract task | Active comparator | Device: TD - Abstract taskControl group using Kinect with more virtual activity. |
| TD - Tangible task | Active comparator | Device: TD - Tangible taskControl group using Keyboard with more real activity. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- need to understand the task, assessed by the ability to properly perform three attempts explanatory statement by the evaluator.
Key exclusion criteria (2 listed)
- of incomprehension.
- no completion of the task.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASD - Abstract taskExperimental group using Kinect with more virtual activity. | Device | ASD - Abstract task |
| ASD - Tangible taskExperimental group using Keyboard with more real activity. | Device | ASD - Tangible task |
| TD - Abstract taskControl group using Kinect with more virtual activity. | Device | TD - Abstract task |
| TD - Tangible taskControl group using Keyboard with more real activity. | Device | TD - Tangible task |
Primary outcome
Change in performance, measured by coincident timing task
Time frame: 1 day
The participants who will perform the abstract task first, will present decrease on performance, measured by the coincident timing task.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos BM Monteiro, Ph.D. principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
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.