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Clinical Trial Summary

The objective of the present study is to develop a therapeutic, adaptive, and enjoyable game that will be used by children with CVI between the mental age of 3 and 12 years. Such a game will be easy to use and implement by the children, their parents, and therapists.


Clinical Trial Description

The aim of this project is to develop a novel and adaptive gamified visual perceptual therapy platform for children with cerebral visual impairment. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04051983
Study type Observational [Patient Registry]
Source Universitaire Ziekenhuizen KU Leuven
Contact
Status Completed
Phase
Start date January 2, 2018
Completion date February 25, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05048550 - Babies in Glasses; a Feasibility Study. N/A
Completed NCT05102955 - Turkish Validity and Reliability of the Visual Function Classification System (VFCS)
Recruiting NCT05014503 - A Computerized, Adaptive Therapeutic Gaming Approach Training Visual Perceptual Skills in Children With CVI N/A