iVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment
NCT ID: NCT04051983
Last Updated: 2022-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2018-01-02
2021-02-25
Brief Summary
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Detailed Description
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This is a multi-centered study involving multiple partners, namely KU Leuven, VUB, UGent, and a subcontracted game developer. Children and parents will take part during different phases of the research project as described in detail in the different phases below.
Phase I: Quantification of the visual profile (WP1) A quantification of the visual profile of children with CVI will be made by KU Leuven. This will be done using the results conducted at consultations at the CVI clinic at the Centre For Developmental Disabilities Leuven, Centrum Ganspoel, and the CP Reference Centre. A group of 50 children with CVI will be retrospectively recruited and results from their perceptual tests will be used to quantify their visual profile.
Phase II: Definition of user and technical requirements (WP1). A definition of user requirements for the development of the software and mini-games will be identified based on at least two focus groups involving parents and therapists. Two focus groups with parents/caretakes and therapists (one for each age group of the children) each lasting maximum three hours with a limit of 10 participants.
There is also a step involving the technical foundations and development of building blocks, but this will not involve patients, therefore it is not discussed further (WP2).
Phase III: Development and validation of the Relative Enjoyment Scale for Primary School Children (RES-C;WP1). The development and validation of the Relative Enjoyment Scale for Primary School Children (RES-C) instrument will be developed considering not just the affective and the cognitive dimensions of RES-C, but also its socio-cultural embeddedness, by measuring the child's experience in relation to what they have encountered before their experience horizon. The questionnaire will be developed by structured individual interviews with 20 children (10 from each age group).
Phase IV: Initial prototype testing (WP3). During prototype development a game design document will be created, specifying what the core gameplay mechanics are, how the game will look in terms of art and customizable visuals/gameplay. VUB will use the coded visual perceptual profile of the children and map these profiles onto the appropriate game difficulty levels for each child. Prototype testing will occur using structured interviews with 20 children (10 from each age group) while they play the game.
The present study will end in October 2020. Phase I, Phase II, and Phase III will be completed by October 2019. Phase IV will be completed by October 2020.
Conditions
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Study Design
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OTHER
OTHER
Eligibility Criteria
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Inclusion Criteria
* Gross Motor Function Classification (GMFCS) level I-IV
* Two age groups; 3-7 and 8-12 years of mental age
Exclusion Criteria
* severely limited motor abilities (cerebral palsy with a gross motor function classification level V)
* severely limited or unable to express their experiences with the game due to serious speech disorders, deafness, autism
* visual acuity of ≤ 3/10
3 Years
12 Years
ALL
No
Sponsors
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Research Foundation Flanders
OTHER
KU Leuven
OTHER
Free University of Brussels
OTHER
University Ghent
OTHER
Ganspoel
UNKNOWN
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Els Ortibus, Professor
Role: STUDY_DIRECTOR
UZ Leuven
Locations
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UZ Leuven
Leuven, Vlaams-brabant, Belgium
Countries
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Other Identifiers
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S61226
Identifier Type: -
Identifier Source: org_study_id