Clinical trial NCT04051983: iVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment
Official title: iVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Perceptual Weakness (Disorder)
Cerebral Visual Impairment
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Research Foundation Flanders
name: KU Leuven
name: Free University of Brussels
name: University Ghent
name: Ganspoel
First posted: 2019-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty children will be recruited from the consultations at the CVI clinic at the Centre For Developmental Disabilities Leuven, from Centrum Ganspoel, and the CP reference Centre of the UZ Leuven.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Visual perceptual deficits or diagnosed with CVI
* Gross Motor Function Classification (GMFCS) level I-IV
* Two age groups; 3-7 and 8-12 years of mental age

Exclusion Criteria:

* mental age below 3 and above 12 years of mental age
* 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

Primary outcomes:
measure: L94 Visual Perceptual Battery
timeFrame: 25 minutes.
measure: Test of Visual Perceptual Skills (TVPS)
timeFrame: 30 minutes.
measure: Developmental Test of Visual - Motor Integration (Beery VMI)
timeFrame: 20 minutes.
measure: Developmental Neuropsychological Assessment (NEPSY-II-NL)
timeFrame: Subtests geometric puzzles and arrows, 20 minutes.
measure: Revisie Amsterdamse Kinderintelligentie Test (RAKIT)
timeFrame: Subtests Hidden figures and Figure recogntion, 20 minutes.
measure: Relative Enjoyment Scale for Primary School Children adapted for cerebral visual impairment (RESC-CVI)
timeFrame: 10 minutes
measure: Preschool judgment of line orientation (PJLO)
timeFrame: 10 minutes.
measure: Motion perception tasks
timeFrame: 20 minutes.
measure: The Flemish cerebral visual impairment questionnaire (FCVIQ)
timeFrame: 10 minutes.
Secondary outcomes:
measure: Snijders-Oomen Non-verbal intelligence test (SON-R 6-40)
timeFrame: 60 minutes.
measure: Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III-NL)
timeFrame: Non-verbal subtests, 45 minutes.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-brabant
Study officials:
affiliation: UZ Leuven
name: Els Ortibus, Professor
role: STUDY_DIRECTOR
References: