Back to resultsAugmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities
Primary Purpose
Intellectual Disability
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
MoviLetrando
MoveHero
Sponsored by
About this trial
This is an interventional prevention trial for Intellectual Disability focused on measuring assitive technology, virtual reality games, intellectual disability, augmentative and alternative communication
Eligibility Criteria
Inclusion Criteria:
- All the children that uses to go the institution where the data collection will be realised (APAE).
Exclusion Criteria:
- Those who decline to participate
- Those who are not present in the two days of evaluation.
Sites / Locations
- Associação de Pais e Amigos dos ExcepcionaisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MoviLetrando-MoveHero
MoveHero-MoviLetrando
Arm Description
Half of the children will play first two different levels of the game MoviLetrando (2 minutes each) and, after the game MoveHero, more 2 minutes
The other half of the children will play first 2 minutes of the game MoveHero and after, two different levels of the Game MoviLetrando, two minutes each.
Outcomes
Primary Outcome Measures
total reaction time
decrease in time indicates a better performance
Secondary Outcome Measures
time MoviLetrando
less time to hit the targets indicates a better performance
acerts MoviLetrando
more hits indicates a better performance
Full Information
NCT ID
NCT03033797
First Posted
January 20, 2017
Last Updated
August 14, 2017
Sponsor
Faculdade de Medicina do ABC
1. Study Identification
Unique Protocol Identification Number
NCT03033797
Brief Title
Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities
Official Title
Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2016 (Actual)
Primary Completion Date
March 10, 2018 (Anticipated)
Study Completion Date
March 24, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Medicina do ABC
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
Background: Games using motion capture from webcam have become increasingly popular. A population that lacks much stimulus in the teaching-learning process has under-explored the benefits of this kind of games: The Intellectually Disabled. The aim of this study is to analyse the effectiveness of games with virtual reality in the total reaction time. Method: A convenience sample of 165 Intellectually Disabled participants will have their performance measured using a virtual reality game. The intervention is to play two different games twice, in two sessions with an interval of, at least, seven days between the sessions. Participants will be randomized between two raters, both master students.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
Keywords
assitive technology, virtual reality games, intellectual disability, augmentative and alternative communication
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MoviLetrando-MoveHero
Arm Type
Experimental
Arm Description
Half of the children will play first two different levels of the game MoviLetrando (2 minutes each) and, after the game MoveHero, more 2 minutes
Arm Title
MoveHero-MoviLetrando
Arm Type
Experimental
Arm Description
The other half of the children will play first 2 minutes of the game MoveHero and after, two different levels of the Game MoviLetrando, two minutes each.
Intervention Type
Device
Intervention Name(s)
MoviLetrando
Intervention Description
Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.
Intervention Type
Device
Intervention Name(s)
MoveHero
Intervention Description
Half of the participants will play 2 minutes of the game MoveHero.
Primary Outcome Measure Information:
Title
total reaction time
Description
decrease in time indicates a better performance
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
time MoviLetrando
Description
less time to hit the targets indicates a better performance
Time Frame
up to 15 days
Title
acerts MoviLetrando
Description
more hits indicates a better performance
Time Frame
up to 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All the children that uses to go the institution where the data collection will be realised (APAE).
Exclusion Criteria:
Those who decline to participate
Those who are not present in the two days of evaluation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Regiani Guarnieri
Phone
4899344597
Email
regianig1@gmail.com
Facility Information:
Facility Name
Associação de Pais e Amigos dos Excepcionais
City
São Paulo
ZIP/Postal Code
04040-033
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Viviane AM Perico
Phone
+551150807009
Ext
345
Email
vivianeperico@apaesp.org.br
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities
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