Visual Perceptual Weakness (Disorder)iVisionNCT04051983
iVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment
An observational study of Visual Perceptual Weakness (Disorder) and Cerebral Visual Impairment, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Visual Perceptual Weakness (Disorder), Cerebral Visual Impairment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jan 2018to 25 Feb 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Medical subject headings
- Blindness, Cortical
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 25 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).
Measured: 30 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).
Measured: 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).
Measured: 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).
Measured: Subtests Hidden figures and Figure recogntion, 20 minutes.
Relative Enjoyment Scale for Primary School Children adapted for cerebral visual impairment (RESC-CVI)
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)
Measured: 10 minutes
Preschool judgment of line orientation (PJLO)
The PJLO is an extension of the Benton judgment of line orientation task and is administered to children between the age of 3.25 and 6 years. This test includes 24 items where the orientation of one or two target lines needs to be matched to 2, 4, or 11 choices (Stiers et al., 2005).
Measured: 10 minutes.
Motion perception tasks
Motion perception tasks measure motion-defined form, global motion coherence, motion speed, and biological motion, and can be administered to children between the age of 4 and 6 years. In motion-defined form, an object is concealed in a random dot kinematogram and the child is required to identify the image seen. In global motion coherence, the child indicates in which half of the display, left or right, a coherently moving strip forming a horizontal bar is located. In motion speed, two contours of a car are shown next to each other with moving dots inside, and the child indicates in which car the dots are moving at the highest speed. In biological motion, two dot matrices are shown, one is a human-point light walker (walking man) and the other one is a phasescrambled point-light figure, and the child should indicate the walking man (Van der Zee et al., 2019).
Measured: 20 minutes.
The Flemish cerebral visual impairment questionnaire (FCVIQ)
The FCVIQ is a 46-item screening tool for CVI filled out by caregivers using a binary response format (yes or no). This tool screens for visual perceptual difficulties in daily life (Ortibus et al., 2011).
Measured: 10 minutes.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Non-verbal subtests, 45 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start2 Jan 2018
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Perceptual Weakness (Disorder)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven, Free University of Brussels, University Ghent, Ganspoel
- Responsible party
- Sponsor
- Investigators
- Els Ortibus, Professor, Study director, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04051983
- Sponsor's protocol ID
- S61226
- Acronym
- iVision
- Status last verified
- Dec 2022
- First submitted
- 7 Aug 2019
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iVision - Development of a Game-based Therapy for Children With Cerebral Visual Impairment
- ClinicalTrials.gov ID
- NCT04051983
- Acronym / sponsor ID
- iVision / S61226
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, KU Leuven, Free University of Brussels, University Ghent, Ganspoel
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
L94 Visual Perceptual Battery
Time frame: 25 minutes.
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)
Test of Visual Perceptual Skills (TVPS)
Time frame: 30 minutes.
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).
Developmental Test of Visual - Motor Integration (Beery VMI)
Time frame: 20 minutes.
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).
Developmental Neuropsychological Assessment (NEPSY-II-NL)
Time frame: Subtests geometric puzzles and arrows, 20 minutes.
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).
Revisie Amsterdamse Kinderintelligentie Test (RAKIT)
Time frame: Subtests Hidden figures and Figure recogntion, 20 minutes.
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).
Relative Enjoyment Scale for Primary School Children adapted for cerebral visual impairment (RESC-CVI)
Time frame: 10 minutes
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)
Preschool judgment of line orientation (PJLO)
Time frame: 10 minutes.
The PJLO is an extension of the Benton judgment of line orientation task and is administered to children between the age of 3.25 and 6 years. This test includes 24 items where the orientation of one or two target lines needs to be matched to 2, 4, or 11 choices (Stiers et al., 2005).
Motion perception tasks
Time frame: 20 minutes.
Motion perception tasks measure motion-defined form, global motion coherence, motion speed, and biological motion, and can be administered to children between the age of 4 and 6 years. In motion-defined form, an object is concealed in a random dot kinematogram and the child is required to identify the image seen. In global motion coherence, the child indicates in which half of the display, left or right, a coherently moving strip forming a horizontal bar is located. In motion speed, two contours of a car are shown next to each other with moving dots inside, and the child indicates in which car the dots are moving at the highest speed. In biological motion, two dot matrices are shown, one is a human-point light walker (walking man) and the other one is a phasescrambled point-light figure, and the child should indicate the walking man (Van der Zee et al., 2019).
The Flemish cerebral visual impairment questionnaire (FCVIQ)
Time frame: 10 minutes.
The FCVIQ is a 46-item screening tool for CVI filled out by caregivers using a binary response format (yes or no). This tool screens for visual perceptual difficulties in daily life (Ortibus et al., 2011).
2 secondary outcomes
Snijders-Oomen Non-verbal intelligence test (SON-R 6-40)
Time frame: 60 minutes.
Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III-NL)
Time frame: Non-verbal subtests, 45 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Els Ortibus, Professor study director
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Perceptual Weakness (Disorder) and Cerebral Visual Impairment, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
L94 Visual Perceptual Battery (time frame: 25 minutes.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.