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

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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

Tracking Information
First Submitted Date  ICMJE January 20, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date August 16, 2017
Actual Study Start Date  ICMJE March 8, 2016
Estimated Primary Completion Date March 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
total reaction time [ Time Frame: 6 minutes ]
decrease in time indicates a better performance
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • time MoviLetrando [ Time Frame: up to 15 days ]
    less time to hit the targets indicates a better performance
  • acerts MoviLetrando [ Time Frame: up to 15 days ]
    more hits indicates a better performance
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities
Official Title  ICMJE Augmentative and Alternative Communication in Games With Virtual Reality in Intellectual Disabilities
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Intellectual Disability
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Device: MoviLetrando
    • Device: 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.
    Interventions:
    • Device: MoviLetrando
    • Device: MoveHero
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
165
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 24, 2018
Estimated Primary Completion Date March 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03033797
Other Study ID Numbers  ICMJE 54172416.6.0000.0082
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Regiani Guarnieri, Faculdade de Medicina do ABC
Study Sponsor  ICMJE Faculdade de Medicina do ABC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Faculdade de Medicina do ABC
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP