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Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03033797
Recruitment Status : Unknown
Verified August 2017 by Regiani Guarnieri, Faculdade de Medicina do ABC.
Recruitment status was:  Recruiting
First Posted : January 27, 2017
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Regiani Guarnieri, Faculdade de Medicina do ABC

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.

Condition or disease Intervention/treatment Phase
Intellectual Disability Device: MoviLetrando Device: MoveHero Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities
Actual Study Start Date : March 8, 2016
Estimated Primary Completion Date : March 10, 2018
Estimated Study Completion Date : March 24, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MoviLetrando-MoveHero
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
Device: MoviLetrando
Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.

Device: MoveHero
Half of the participants will play 2 minutes of the game MoveHero.

Experimental: MoveHero-MoviLetrando
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.
Device: MoviLetrando
Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.

Device: MoveHero
Half of the participants will play 2 minutes of the game MoveHero.




Primary Outcome Measures :
  1. total reaction time [ Time Frame: 6 minutes ]
    decrease in time indicates a better performance


Secondary Outcome Measures :
  1. time MoviLetrando [ Time Frame: up to 15 days ]
    less time to hit the targets indicates a better performance

  2. acerts MoviLetrando [ Time Frame: up to 15 days ]
    more hits indicates a better performance



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033797


Contacts
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Contact: Regiani Guarnieri 4899344597 regianig1@gmail.com

Locations
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Brazil
Associação de Pais e Amigos dos Excepcionais Recruiting
São Paulo, Brazil, 04040-033
Contact: Viviane AM Perico    +551150807009 ext 345    vivianeperico@apaesp.org.br   
Sponsors and Collaborators
Faculdade de Medicina do ABC
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Responsible Party: Regiani Guarnieri, Graphic Computer Specialist, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT03033797    
Other Study ID Numbers: 54172416.6.0000.0082
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regiani Guarnieri, Faculdade de Medicina do ABC:
assitive technology
virtual reality games
intellectual disability
augmentative and alternative communication
Additional relevant MeSH terms:
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Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders