iVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment (iVision)

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.

Study Overview

• Status: Unknown
• Conditions: Visual Perceptual Weakness (Disorder); Cerebral Visual Impairment

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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-brabant
    • Leuven, Vlaams-brabant, Belgium, 3000
      • Recruiting
      • UZ Leuven
      • Contact: Nofar Ben Itzhak, Master; Email: nofar.benitzhak@kuleuven.be
      • Contact: Inge Franki, PhD; Phone Number: 016337495 016337495; Email: inge.franki@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
L94 Visual Perceptual Battery	L94 is an object recognition battery for children aged 3-6 years. The test is composed of 5 computer tasks, [visual matching (VISM), overlapping line drawings (OVERL), line drawings occluded by noise (NOISE), De Vos task (DE VOS), unconventional object views (VIEW). (Ortibus et al., 2009)	60 minutes
Test of Visual Perceptual Skills (TVPS)	TVPS-3 is a standardized and norm-referenced task for children age 4-13 years that uses a response format suitable for all children, including those with disabilities. It includes subtasks of visual discrimination, visual memory, visual-spatial relationships, form constancy, visual sequential memory, figure ground, and visual closure (Martin et al., 2006).	45 minutes
Developmental Test of Visual - Motor Integration (Beery VMI)	Beery a standardized and norm-referenced screening tool for visual-motor deficits. It includes updated norms for ages 2 through 18. The VMI helps assess to what extent children can integrate their visual and motor abilities. In addition to a copying task, the child also performs a visual perception matching task of the same constructs seen before in the copy task, and a motor coordination task, developed to assess the supplementary motor deficits. (Beery et al., 2010).	20 minutes
Developmental Neuropsychological Assessment (NEPSY-II-NL)	NEPSY-II-NL is a customizable cognitive assessment tool for children aged 5 to 16 years. It assesses six domains with one integrated instrument, composed of different normed subtests. Among those, visual attention and visuospatial functions, are routinely performed in the diagnostic work up of children with (a suspicion of) CVI. (Korkman, 1998).	Subtests geometric puzzles and arrows, 20 minutes
Revisie Amsterdamse Kinderintelligentie Test (RAKIT)	RAKIT is a paediatric intelligence test, with reference values from a Dutch population of children 4-12.5 years of age. From this test, the subtest "Vertelplaat" is used to evaluate the ability to tell a logic story from a crowded scene, thereby evaluating object recognition, figure ground perception and scene perception (Bleichroth et al., 1987).	Subtests Hidden figures and Recognize figures, 20 minutes
Relative Enjoyment Scale for Primary School Children (RES-C)	The RES-C measures enjoyment by relating it subjectively to a series of other activities which are part of the 'experience horizon' of a child using visual analogue scales (Van Looy et al., 2016)	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Snijders-Oomen Non-verbal intelligence test (SON-R 6-40)	The SON-R 6-40 consists of four subtests containing two or three parallel series of twelve to thirteen items with increasing difficulty. The testing procedure of this test is adaptive, whereby the starting point of a series is decided on basis of the score on the previous series of the subtest.	60 minutes
Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III-NL)	Third Edition (WPPSI-III) is designed to test intelligence (cognitive ability) in children ages 2 years 6 months to 7 years 3 months. The test consists of 14 subtests from which five subtests measure the non-verbal intelligence.	Non-verbal subtests, 60 minutes

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven; University Ghent; Research Foundation Flanders; Free University of Brussels; Ganspoel
• Investigators: Study Director: Els Ortibus, Professor, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision, Low; Vision Disorders
• Other Study ID Numbers: S61226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No