NCT03033797

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2018

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

2 years

First QC Date

January 20, 2017

Last Update Submit

August 14, 2017

Conditions

Keywords

assitive technologyvirtual reality gamesintellectual disabilityaugmentative and alternative communication

Outcome Measures

Primary Outcomes (1)

  • total reaction time

    decrease in time indicates a better performance

    6 minutes

Secondary Outcomes (2)

  • time MoviLetrando

    up to 15 days

  • acerts MoviLetrando

    up to 15 days

Study Arms (2)

MoviLetrando-MoveHero

EXPERIMENTAL

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: MoviLetrandoDevice: MoveHero

MoveHero-MoviLetrando

EXPERIMENTAL

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: MoviLetrandoDevice: MoveHero

Interventions

Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.

MoveHero-MoviLetrandoMoviLetrando-MoveHero
MoveHeroDEVICE

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

MoveHero-MoviLetrandoMoviLetrando-MoveHero

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All the children that uses to go the institution where the data collection will be realised (APAE).

You may not qualify if:

  • Those who decline to participate
  • Those who are not present in the two days of evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associação de Pais e Amigos dos Excepcionais

São Paulo, 04040-033, Brazil

RECRUITING

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Regiani Guarnieri

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graphic Computer Specialist

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 27, 2017

Study Start

March 8, 2016

Primary Completion

March 10, 2018

Study Completion

March 24, 2018

Last Updated

August 16, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations