Skip to main content
OpenTrials
Completed

NCT Number: NCT05014503

A Computerized, Adaptive Therapeutic Gaming Approach Training Visual Perceptual Skills in Children With CVI

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Visual Impairment Blindness Blindness, Cortical Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Adaptive Therapeutic gaming

Other

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 gaming

Other

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Secondary outcomes

  1. Visual Perceptual Tests (individual test scores) (younger children, age 3-6y)

    Time frame: pre-intervention (at day 0)

    • 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).

  2. Visual Perceptual Tests (individual test scores) (younger children, dev age 3-6y)

    Time frame: immediately post-intervention (after 3 months)

    • 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).

  3. Visual Perceptual Tests (individual test scores) (younger children, age 3-6y)

    Time frame: at 3 months follow-up (after 6 months)

    • 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).

  4. Visual Perceptual Tests (individual test scores) (older children, age 6-12y)

    Time frame: pre-intervention (at day 0)

    • 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.

  5. Visual Perceptual Tests (individual test scores) (older children, aged 6-12y)

    Time frame: immediately post-intervention (after 3 months)

    • 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.

  6. Visual Perceptual Tests (individual test scores) (older children, aged 6-12y)

    Time frame: at 3 months follow-up (after 6 months)

    • 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.

  7. Eye-tracking

    Time frame: pre-intervention (at day 0)

    eye-movements using eye-tracking

  8. Eye-tracking

    Time frame: immediately post-intervention (after 3 months)

    eye-movements using eye-tracking

  9. Eye-tracking

    Time frame: at 3 months follow-up (after 6 months)

    eye-movements using eye-tracking

  10. Daily functioning questionnaires

    Time frame: pre-intervention (at day 0)

    Questionnaires evaluating daily functioning: Insight Question Inventory, (IQI), Pediatric Quality of Life Inventory (PedsQL), the Flemish cerebral visual impairment questionnaire (FCVIQ).

  11. Daily functioning questionnaires

    Time frame: immediately post-intervention (after 3 months)

    Questionnaires evaluating daily functioning: Insight Question Inventory, (IQI), Pediatric Quality of Life Inventory (PedsQL), the Flemish cerebral visual impairment questionnaire (FCVIQ).

  12. Daily functioning questionnaires

    Time frame: at 3 months follow-up (after 6 months)

    Questionnaires evaluating daily functioning: Insight Question Inventory, (IQI), Pediatric Quality of Life Inventory (PedsQL), the Flemish cerebral visual impairment questionnaire (FCVIQ).

  13. Functional evaluation of visual perception

    Time frame: pre-intervention (at day 0)

    Change in an adapted Virtual Toybox (Bauer et al., 2008)

  14. Functional evaluation of visual perception

    Time frame: immediately post-intervention (after 3 months)

    Adapted Virtual Toybox (Bauer et al., 2008)

  15. Functional evaluation of visual perception

    Time frame: at 3 months follow-up (after 6 months)

    Adapted Virtual Toybox (Bauer et al., 2008)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium
  • Vrije Universiteit Brussel

Registry information

Official study title

A Randomized Controlled Trial to Evaluate the Effectiveness of a Computerized, Adaptive Therapy Approach for Children With Cerebral Visual Impairment

Acronym: iVision2_WP3

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2021
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.