Cerebral Visual ImpairmentiVision2_WP3NCT05014503
A Computerized, Adaptive Therapeutic Gaming Approach Training Visual Perceptual Skills in Children With CVI
A study testing Adaptive Therapeutic gaming and Non-adaptive Therapeutic gaming in people with Cerebral Visual Impairment, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This clinical trial aims to compare the effectiveness of our adaptive, therapeutic game to the effectiveness of the same game, without the adaptive component. In the adaptive game, the game entry level is adapted to the visual perceptual capacities of the child, as defined by the visual perceptual profile. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Cerebral Visual Impairment
- What is being tested?
- Adaptive Therapeutic gaming and Non-adaptive Therapeutic gaming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteBelgium
- Study dates
- 2 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- Voluntary written informed consent of the participant or their legally authorized representative
- A confirmed diagnosis of CVI
- Dutch-speaking
- A developmental age between 3 and 12 years.
- Sufficient motor abilities (cerebral palsy with a Gross Motor Function Classification level <V)
- Sufficient fine motor function to handle a tablet or laptop (Manual Ability Classification System level <4)
- Able to express their experiences with the game.
- A visual acuity of more than 0.2 (Snellen notation)
Who cannot join
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Children not speaking or understanding Dutch language
- Children with limited gross motor function abilities (GMFCS V)
- Children with limited hand function (MACS 4-5)
- Children unable to express their experiences with the game due to serious speech disorders, deafness or autism.
- A visual acuity of less than 0.2 (Snellen notation)
- Serious behavioural problems limiting participation to the games
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Effectiveness of a Computerized, Adaptive Therapy Approach for Children With Cerebral Visual Impairment
This clinical trial aims to compare the effectiveness of our adaptive, therapeutic game to the effectiveness of the same game, without the adaptive component. In the adaptive game, the game entry level is adapted to the visual perceptual capacities of the child, as defined by the visual perceptual profile. In addition, the difficulty level of the adaptive game will adapt itself to the gaming results and behaviour of the child. The non-adaptive version of the game consists of the same set of mini-games, but the entry-level is the same for all children (basic or 0 entry-level) and gradually increased, independent of the gaming results, success and behaviour of the child. The researchers will use a double-blind, randomized controlled trial design, including children with a developmental age between 3 and 12 years old, a diagnosis of CVI, acuity >0.2, with sufficient manual coordination to control a mouse, keypad or touch screen. All children will use the gamified therapy program for three months, with a minimum of three times per week, 15- 20 minutes. A blinded evaluator will evaluate the effectiveness on the main components of the visual perceptual profile of the child (primary outcome), on eye tracking parameters, functional vision and quality of life, at the end and at three months follow-up. Enjoyment and user experience will be monitored closely during the intervention period. As usual and regular therapy of the children will not be influenced during the intervention period, we will ask the parents and/or caretaker to register all other relevant gaming and therapy activities performed during that period. It is hypothesized that children will benefit more from an individualized, adaptive training approach compared to the generic, non-adaptive version of the program.
Read the detailed description
Cerebral Visual Impairment (CVI) is the most common cause of visual disability in developed countries (one to two cases per 1000 live births). A person with CVI usually has normal eye function but processing visual information in the brain is hindered. This results in a complex variation of symptoms, ranging from problems with object and shape recognition over problems with figure ground and cluttered scenes to deficits in spatial navigation. Each child with CVI presents with a nearly unique visual perceptual profile, due to the varying nature of the underlying damage and the appearance of age related deficits. In a previous project, we developed a method to quantify the visual profile of children with CVI, enabling more individualized and targeted therapy. The researchers developed an adaptive, personalized gamified visual perceptual therapy program for children with CVI, based on this quantified visual profile, with the aim to apply a targeted, individualized approach that strengthens motivation and thereby increases effectiveness.
This clinical trial aims to compare the effectiveness of our adaptive, therapeutic game to the effectiveness of the same game, without the adaptive component. In the adaptive game, the game entry level is adapted to the visual perceptual capacities of the child, as defined by the visual perceptual profile. In addition, the difficulty level of the adaptive game will adapt itself to the gaming results and behaviour of the child. The non-adaptive version of the game consists of the same set of mini-games, but the entry-level is the same for all children (basic or 0 entry-level) and gradually increased, independent of the gaming results, success and behaviour of the child.
The researchers will use a double-blind, randomized controlled trial design, including children with a developmental age between 3 and 12years old, a diagnosis of CVI, acuity >0.2, with sufficient manual coordination to control a mouse, keypad or touch screen. All children will use the gamified therapy program for three months, with a minimum of three times per week, 15- 20 minutes. The software will be installed on a personal device of choice by the child and/or its parents. Children willing to participate, but not having a personal device, will receive a tablet computer from the researchers during the intervention period. A blinded evaluator will evaluate the effectiveness on the main components of the visual perceptual profile of the child (primary outcome), on eye tracking parameters, functional vision and quality of life, at the end and at three months follow-up. Enjoyment and user experience will be monitored closely during the intervention period. As usual and regular therapy of the children will not be influenced during the intervention period, we will ask the parents and/or caretaker to register all other relevant gaming and therapy activities performed during that period.
- Conditions
- Cerebral Visual Impairment
- Being tested
- Adaptive Therapeutic gaming, Non-adaptive Therapeutic gaming
- Keywords
- Cerebral Visual Impairment, Training, Rehabilitation, Therapeutic gaming, Adaptive therapy, Randomized Controlled Trial, Visual Perception
- Medical subject headings
- Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Therapeutic gamingOther
All children will be asked to use the adaptive version of the therapeutic game for three months, during their free time, at home or at the special school where they stay. They will be asked to play the game minimally three times per week between 20-30 minutes per session. The researchers will install the game on a device of choice for the children. Back-up devices are available from the study team to ensure that children having no suitable device can participate in the study. The parent and/or caretaker will be asked to support the child in starting the program, but not to intervene during the actual game time. The game is designed to ensure that children can play independently. Therefore, children will be able to play at home, at school or during their free time. The program will not replace their regular therapy program, but will be provided additionally. The number of regular therapy hours will however be registered.
Non-adaptive Therapeutic gamingOther
All children will be asked to use the non-adaptive version of the therapeutic game for three months, during their free time, at home or at the special school where they stay. They will be asked to play the game minimally three times per week between 20-30 minutes per session. The researchers will install the game on a device of choice for the children. Back-up devices are available from the study team to ensure that children having no suitable device can participate in the study. The parent and/or caretaker will be asked to support the child in starting the program, but not to intervene during the actual game time. The game is designed to ensure that children can play independently. Therefore, children will be able to play at home, at school or during their free time. The program will not replace their regular therapy program, but will be provided additionally. The number of regular therapy hours will however be registered.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive version of the therapeutic game | Experimental | The adaptive therapeutic game will use a game-entry level that is based on the individual visual perceptual profile of the child. Children with higher visual perceptual capacities will be able to start the game at a higher entry level compared to children with lower visual perceptual capacities. Thereby, the entry level will also be different for the different games. In addition, the adaptive game uses an in-game adaptivity system that has been developed using artificial intelligence (more specifically, reinforcement learning): this means that the game can adjust the difficulty automatically, based on the game-behaviour and success of the child. Children learning fast, will more quickly move to higher difficulty levels compared to children learning slower. Thereby, this in-game adaptivity also enables children to return to lower difficulty levels when a difficulty level is too high. Receives: Other: Adaptive Therapeutic gaming |
| Non-adaptive version of the therapeutic game | Active comparator | The non-adaptive therapeutic game will use the same, lowest entry level for all children. During game play, a fixed stepwise increase in difficulty will be built in, not adjusted to the gaming behaviour or success of the child. All children will follow the same, gradual approach in difficulty and a fixed number of trials is set for each difficulty level. To prevent extreme frustration however, a safety margin is integrated by preventing the difficulty level to increase further when a child has more than a predefined number of unsuccessful trials. Likewise, the stepwise increase in difficulty level will only continue after a fixed, predefined number of successful trials. A child will also never return to a lower difficulty level, once a difficulty level is reached. Receives: Other: Non-adaptive Therapeutic gaming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Perceptual Profile
Quantified visual profile as described by Ben Itzhak et al. (2021): at individual (most deviant z-score) and general level (overall visual perceptual capacity in a composite score)
Measured: pre-intervention (Day 0)
Visual Perceptual Profile
Quantified visual profile as described by Ben Itzhak et al. (2021): at individual (most deviant z-score) and general level (overall visual perceptual capacity in a composite score)
Measured: immediately post-intervention (after 3 months of training)
Visual Perceptual Profile
Quantified visual profile as described by Ben Itzhak et al. (2021): at individual (most deviant z-score) and general level (overall visual perceptual capacity in a composite score)
Measured: at 3 months follow-up (after 6 months)
Secondary outcomes (15)
Visual Perceptual Tests (individual test scores) (younger children, age 3-6y)
- L94 Visual Perceptual Battery: object recognition battery which evaluates (degraded) object recognition, figured-ground, motion perception and global-local processing (Ortibus et al., 2015).
- The Beery Visual Motor Integration (Beery VMI): a standardized and norm-referenced screening tool for visual-motor deficits. 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).
- The Preschool Judgement of Line Orientation (PJLO) (Stiers et al., 2005): In 24 items the orientation of one or two target lines has to be matched to 2, 4, or 11 differently orientated choice lines.
- Motion perception tasks: tackling structured motion, motion coherence and biological motion (Van der Zee et al., 2019).
Measured: pre-intervention (at day 0)
Visual Perceptual Tests (individual test scores) (younger children, dev age 3-6y)
- L94 Visual Perceptual Battery: object recognition battery which evaluates (degraded) object recognition, figured-ground, motion perception and global-local processing (Ortibus et al., 2015).
- The Beery Visual Motor Integration (Beery VMI): a standardized and norm-referenced screening tool for visual-motor deficits. 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).
- The Preschool Judgement of Line Orientation (PJLO) (Stiers et al, 2005): In 24 items the orientation of one or two target lines has to be matched to 2, 4, or 11 differently orientated choice lines.
- Motion perception tasks: tackling structured motion, motion coherence and biological otion (Van der Zee et al., 2019).
Measured: immediately post-intervention (after 3 months)
Visual Perceptual Tests (individual test scores) (younger children, age 3-6y)
- L94 Visual Perceptual Battery: object recognition battery which evaluates (degraded) object recognition, figured-ground, motion perception and global-local processing (Ortibus et al., 2015).
- The Beery Visual Motor Integration (Beery VMI): a standardized and norm-referenced screening tool for visual-motor deficits. 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).
- The Preschool Judgement of Line Orientation (PJLO) (Stiers et al., 2005): In 24 items the orientation of one or two target lines has to be matched to 2, 4, or 11 differently orientated choice lines.
- Motion perception tasks: tackling structured motion, motion coherence and biological otion (Van der Zee et al., 2019).
Measured: at 3 months follow-up (after 6 months)
Visual Perceptual Tests (individual test scores) (older children, age 6-12y)
- Test of Visual Perceptual Skills-3 (TVPS-3): includes subtasks of visual discrimination, visual memory, visual-spatial relationships, form constancy, visual sequential memory, figure ground, and visual closure (Martin et al., 2006).
- Beery VMI (see above)
- Subtasks from the Revisie Amsterdamse Kinder Intelligentie test 2 (Rakit 2), (Bleichrodt et al. (1999)): In the Hidden figures subtasks, hidden objects need to be identified in a crowded background. In the figure recognition subtask, the child has to recognize incomplete drawings from everyday objects.
- Subtasks from the Developmental Neuropsychological Assessment (NEPSY-II-Nl): evaluating different aspects of visuospatial functioning. In the arrows subtask, the child must determine visually which arrows will end up in the middle of a target if they were extended. In the geometric puzzles subtask, the child must find geometric figures amongst other geometric figures.
Measured: pre-intervention (at day 0)
Visual Perceptual Tests (individual test scores) (older children, aged 6-12y)
- Test of Visual Perceptual Skills-3 (TVPS-3): includes subtasks of visual discrimination, visual memory, visual-spatial relationships, form constancy, visual sequential memory, figure ground, and visual closure (Martin et al., 2006).
- Beery VMI (see above)
- Subtasks from the Revisie Amsterdamse Kinder Intelligentie test 2 (Rakit 2), (Bleichrodt et al. (1999)): In the Hidden figures subtasks, hidden objects need to be identified in a crowded background. In the figure recognition subtask, the child has to recognize incomplete drawings from everyday objects.
- Subtasks from the Developmental Neuropsychological Assessment (NEPSY-II-Nl): evaluating different aspects of visuospatial functioning. In the arrows subtask, the child must determine visually which arrows will end up in the middle of a target if they were extended. In the geometric puzzles subtask, the child must find geometric figures amongst other geometric figures.
Measured: immediately post-intervention (after 3 months)
Visual Perceptual Tests (individual test scores) (older children, aged 6-12y)
- Test of Visual Perceptual Skills-3 (TVPS-3): includes subtasks of visual discrimination, visual memory, visual-spatial relationships, form constancy, visual sequential memory, figure ground, and visual closure (Martin et al., 2006).
- Beery VMI (see above)
- Subtasks from the Revisie Amsterdamse Kinder Intelligentie test 2 (Rakit 2), (Bleichrodt et al. (1999)): In the Hidden figures subtasks, hidden objects need to be identified in a crowded background. In the figure recognition subtask, the child has to recognize incomplete drawings from everyday objects.
- Subtasks from the Developmental Neuropsychological Assessment (NEPSY-II-Nl): evaluating different aspects of visuospatial functioning. In the arrows subtask, the child must determine visually which arrows will end up in the middle of a target if they were extended. In the geometric puzzles subtask, the child must find geometric figures amongst other geometric figures.
Measured: at 3 months follow-up (after 6 months)
Eye-tracking
eye-movements using eye-tracking
Measured: pre-intervention (at day 0)
Eye-tracking
eye-movements using eye-tracking
Measured: immediately post-intervention (after 3 months)
Eye-tracking
eye-movements using eye-tracking
Measured: at 3 months follow-up (after 6 months)
Daily functioning questionnaires
Questionnaires evaluating daily functioning: Insight Question Inventory, (IQI), Pediatric Quality of Life Inventory (PedsQL), the Flemish cerebral visual impairment questionnaire (FCVIQ).
Measured: pre-intervention (at day 0)
Daily functioning questionnaires
Questionnaires evaluating daily functioning: Insight Question Inventory, (IQI), Pediatric Quality of Life Inventory (PedsQL), the Flemish cerebral visual impairment questionnaire (FCVIQ).
Measured: immediately post-intervention (after 3 months)
Daily functioning questionnaires
Questionnaires evaluating daily functioning: Insight Question Inventory, (IQI), Pediatric Quality of Life Inventory (PedsQL), the Flemish cerebral visual impairment questionnaire (FCVIQ).
Measured: at 3 months follow-up (after 6 months)
Functional evaluation of visual perception
Change in an adapted Virtual Toybox (Bauer et al., 2008)
Measured: pre-intervention (at day 0)
Functional evaluation of visual perception
Adapted Virtual Toybox (Bauer et al., 2008)
Measured: immediately post-intervention (after 3 months)
Functional evaluation of visual perception
Adapted Virtual Toybox (Bauer et al., 2008)
Measured: at 3 months follow-up (after 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start2 Jan 2022
- Primary completion30 May 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Visual ImpairmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind, randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Els Ortibus, MD PhD, Principal investigator, UZ Leuven / KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014503
- Sponsor's protocol ID
- s65773
- Acronym
- iVision2_WP3
- Status last verified
- Dec 2024
- First submitted
- 4 Aug 2021
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared with other researchers. Only upon request, in specific conditions, when ethical approval and after additional patient consent, data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Effectiveness of a Computerized, Adaptive Therapy Approach for Children With Cerebral Visual Impairment
- ClinicalTrials.gov ID
- NCT05014503
- Acronym / sponsor ID
- iVision2_WP3 / s65773
- Conditions
- Cerebral Visual Impairment
- Keywords
- Cerebral Visual Impairment, Training, Rehabilitation, Therapeutic gaming, Adaptive therapy, Randomized Controlled Trial, Visual Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Fund for Scientific Research, Flanders, Belgium
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Aug 2021 (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.
This clinical trial aims to compare the effectiveness of our adaptive, therapeutic game to the effectiveness of the same game, without the adaptive component. In the adaptive game, the game entry level is adapted to the visual perceptual capacities of the child, as defined by the visual perceptual profile. In addition, the difficulty level of the adaptive game will adapt itself to the gaming results and behaviour of the child. The non-adaptive version of the game consists of the same set of mini-games, but the entry-level is the same for all children (basic or 0 entry-level) and gradually increased, independent of the gaming results, success and behaviour of the child. The researchers will use a double-blind, randomized controlled trial design, including children with a developmental age between 3 and 12 years old, a diagnosis of CVI, acuity >0.2, with sufficient manual coordination to control a mouse, keypad or touch screen. All children will use the gamified therapy program for three months, with a minimum of three times per week, 15- 20 minutes. A blinded evaluator will evaluate the effectiveness on the main components of the visual perceptual profile of the child (primary outcome), on eye tracking parameters, functional vision and quality of life, at the end and at three months follow-up. Enjoyment and user experience will be monitored closely during the intervention period. As usual and regular therapy of the children will not be influenced during the intervention period, we will ask the parents and/or caretaker to register all other relevant gaming and therapy activities performed during that period. It is hypothesized that children will benefit more from an individualized, adaptive training approach compared to the generic, non-adaptive version of the program.
Detailed description
Cerebral Visual Impairment (CVI) is the most common cause of visual disability in developed countries (one to two cases per 1000 live births). A person with CVI usually has normal eye function but processing visual information in the brain is hindered. This results in a complex variation of symptoms, ranging from problems with object and shape recognition over problems with figure ground and cluttered scenes to deficits in spatial navigation. Each child with CVI presents with a nearly unique visual perceptual profile, due to the varying nature of the underlying damage and the appearance of age related deficits. In a previous project, we developed a method to quantify the visual profile of children with CVI, enabling more individualized and targeted therapy. The researchers developed an adaptive, personalized gamified visual perceptual therapy program for children with CVI, based on this quantified visual profile, with the aim to apply a targeted, individualized approach that strengthens motivation and thereby increases effectiveness.
This clinical trial aims to compare the effectiveness of our adaptive, therapeutic game to the effectiveness of the same game, without the adaptive component. In the adaptive game, the game entry level is adapted to the visual perceptual capacities of the child, as defined by the visual perceptual profile. In addition, the difficulty level of the adaptive game will adapt itself to the gaming results and behaviour of the child. The non-adaptive version of the game consists of the same set of mini-games, but the entry-level is the same for all children (basic or 0 entry-level) and gradually increased, independent of the gaming results, success and behaviour of the child.
The researchers will use a double-blind, randomized controlled trial design, including children with a developmental age between 3 and 12years old, a diagnosis of CVI, acuity >0.2, with sufficient manual coordination to control a mouse, keypad or touch screen. All children will use the gamified therapy program for three months, with a minimum of three times per week, 15- 20 minutes. The software will be installed on a personal device of choice by the child and/or its parents. Children willing to participate, but not having a personal device, will receive a tablet computer from the researchers during the intervention period. A blinded evaluator will evaluate the effectiveness on the main components of the visual perceptual profile of the child (primary outcome), on eye tracking parameters, functional vision and quality of life, at the end and at three months follow-up. Enjoyment and user experience will be monitored closely during the intervention period. As usual and regular therapy of the children will not be influenced during the intervention period, we will ask the parents and/or caretaker to register all other relevant gaming and therapy activities performed during that period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Adaptive version of the therapeutic game | Experimental | Other: Adaptive Therapeutic gamingThe adaptive therapeutic game will use a game-entry level that is based on the individual visual perceptual profile of the child. Children with higher visual perceptual capacities will be able to start the game at a higher entry level compared to children with lower visual perceptual capacities. Thereby, the entry level will also be different for the different games. In addition, the adaptive game uses an in-game adaptivity system that has been developed using artificial intelligence (more specifically, reinforcement learning): this means that the game can adjust the difficulty automatically, based on the game-behaviour and success of the child. Children learning fast, will more quickly move to higher difficulty levels compared to children learning slower. Thereby, this in-game adaptivity also enables children to return to lower difficulty levels when a difficulty level is too high. |
| Non-adaptive version of the therapeutic game | Active comparator | Other: Non-adaptive Therapeutic gamingThe non-adaptive therapeutic game will use the same, lowest entry level for all children. During game play, a fixed stepwise increase in difficulty will be built in, not adjusted to the gaming behaviour or success of the child. All children will follow the same, gradual approach in difficulty and a fixed number of trials is set for each difficulty level. To prevent extreme frustration however, a safety margin is integrated by preventing the difficulty level to increase further when a child has more than a predefined number of unsuccessful trials. Likewise, the stepwise increase in difficulty level will only continue after a fixed, predefined number of successful trials. A child will also never return to a lower difficulty level, once a difficulty level is reached. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Voluntary written informed consent of the participant or their legally authorized representative
- A confirmed diagnosis of CVI
- Dutch-speaking
- A developmental age between 3 and 12 years.
- Sufficient motor abilities (cerebral palsy with a Gross Motor Function Classification level <V)
Key exclusion criteria (8 listed)
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
- Children not speaking or understanding Dutch language
- Children with limited gross motor function abilities (GMFCS V)
- Children with limited hand function (MACS 4-5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Therapeutic gamingAll children will be asked to use the adaptive version of the therapeutic game for three months, during their free time, at home or at the special school where they stay. They will be asked to play the game minimally three times per week between 20-30 minutes per session. The researchers will install the game on a device of choice for the children. Back-up devices are available from the study team to ensure that children having no suitable device can participate in the study. The parent and/or caretaker will be asked to support the child in starting the program, but not to intervene during the actual game time. The game is designed to ensure that children can play independently. Therefore, children will be able to play at home, at school or during their free time. The program will not replace their regular therapy program, but will be provided additionally. The number of regular therapy hours will however be registered. | Other | Adaptive version of the therapeutic game |
| Non-adaptive Therapeutic gamingAll children will be asked to use the non-adaptive version of the therapeutic game for three months, during their free time, at home or at the special school where they stay. They will be asked to play the game minimally three times per week between 20-30 minutes per session. The researchers will install the game on a device of choice for the children. Back-up devices are available from the study team to ensure that children having no suitable device can participate in the study. The parent and/or caretaker will be asked to support the child in starting the program, but not to intervene during the actual game time. The game is designed to ensure that children can play independently. Therefore, children will be able to play at home, at school or during their free time. The program will not replace their regular therapy program, but will be provided additionally. The number of regular therapy hours will however be registered. | Other | Non-adaptive version of the therapeutic game |
Primary outcome
Visual Perceptual Profile
Time frame: pre-intervention (Day 0)
Quantified visual profile as described by Ben Itzhak et al. (2021): at individual (most deviant z-score) and general level (overall visual perceptual capacity in a composite score)
Visual Perceptual Profile
Time frame: immediately post-intervention (after 3 months of training)
Quantified visual profile as described by Ben Itzhak et al. (2021): at individual (most deviant z-score) and general level (overall visual perceptual capacity in a composite score)
Visual Perceptual Profile
Time frame: at 3 months follow-up (after 6 months)
Quantified visual profile as described by Ben Itzhak et al. (2021): at individual (most deviant z-score) and general level (overall visual perceptual capacity in a composite score)
15 secondary outcomes
Visual Perceptual Tests (individual test scores) (younger children, age 3-6y)
Time frame: pre-intervention (at day 0)
Visual Perceptual Tests (individual test scores) (younger children, dev age 3-6y)
Time frame: immediately post-intervention (after 3 months)
Visual Perceptual Tests (individual test scores) (younger children, age 3-6y)
Time frame: at 3 months follow-up (after 6 months)
Visual Perceptual Tests (individual test scores) (older children, age 6-12y)
Time frame: pre-intervention (at day 0)
Visual Perceptual Tests (individual test scores) (older children, aged 6-12y)
Time frame: immediately post-intervention (after 3 months)
Visual Perceptual Tests (individual test scores) (older children, aged 6-12y)
Time frame: at 3 months follow-up (after 6 months)
Eye-tracking
Time frame: pre-intervention (at day 0)
Eye-tracking
Time frame: immediately post-intervention (after 3 months)
Eye-tracking
Time frame: at 3 months follow-up (after 6 months)
Daily functioning questionnaires
Time frame: pre-intervention (at day 0)
Daily functioning questionnaires
Time frame: immediately post-intervention (after 3 months)
Daily functioning questionnaires
Time frame: at 3 months follow-up (after 6 months)
Functional evaluation of visual perception
Time frame: pre-intervention (at day 0)
Functional evaluation of visual perception
Time frame: immediately post-intervention (after 3 months)
Functional evaluation of visual perception
Time frame: at 3 months follow-up (after 6 months)
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 18 Mar 2025.
- Individual participant dataSharing planned: No. No data will be shared with other researchers. Only upon request, in specific conditions, when ethical approval and after additional patient consent, data will be shared.
Related trials for Cerebral Visual Impairment
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Not yet recruiting
NEURO-COGS: Neurometabolic Mechanisms of Cognitive Training in Schizophrenia
Schizophrenia, Schizoaffective Disorder
Recruiting
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Hemianopia, Homonymous, Cortical Blindness, Unspecified Side of Brain
Not yet recruiting
Multisensory Rehabilitation of Vision Loss After Cortical Damage
Cortical Blindness
Not yet recruiting
Remapping Text in Sentence and Word Tasks to Aid Reading With Central Vision Loss
Macular Degeneration, Central Visual Impairment
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, MD PhD principal investigator
UZ Leuven / KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Therapeutic gaming and Non-adaptive Therapeutic gaming in people with 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 8 inclusion and 8 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 18 Mar 2025. 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?
Visual Perceptual Profile (time frame: pre-intervention (Day 0)). The study lists 3 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 18 Mar 2025.