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

Cerebral Visual Impairment Clinical Trial

— iVision2_WP3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014503
• Other study ID #: s65773
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Nofar Ben Itzhak, Drs
• Phone: 0032 16 340645
• Email: nofar.benitzhak[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Voluntary written informed consent of the participant or their legally authorized representative

2. A confirmed diagnosis of CVI

3. Dutch-speaking

4. A developmental age between 3 and 12 years.

5. Sufficient motor abilities (cerebral palsy with a Gross Motor Function Classification level <V)

6. Sufficient fine motor function to handle a tablet or laptop (Manual Ability Classification System level <4)

7. Able to express their experiences with the game.

8. A visual acuity of more than 0.2 (Snellen notation)

Exclusion Criteria:

1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol

2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial

3. Children not speaking or understanding Dutch language

4. Children with limited gross motor function abilities (GMFCS V)

5. Children with limited hand function (MACS 4-5)

6. Children unable to express their experiences with the game due to serious speech disorders, deafness or autism.

7. A visual acuity of less than 0.2 (Snellen notation)

8. Serious behavioural problems limiting participation to the games

Related Conditions & MeSH terms

• Cerebral Visual Impairment
• Vision Disorders
• Vision, Low

Intervention

Other:
• Adaptive Therapeutic gaming
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
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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-brabant

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Fund for Scientific Research, Flanders, Belgium, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	pre-intervention (Day 0)
Primary	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)	immediately post-intervention (after 3 months of training)
Primary	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)	at 3 months follow-up (after 6 months)
Secondary	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).	pre-intervention (at day 0)
Secondary	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).	immediately post-intervention (after 3 months)
Secondary	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).	at 3 months follow-up (after 6 months)
Secondary	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.	pre-intervention (at day 0)
Secondary	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.	immediately post-intervention (after 3 months)
Secondary	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.	at 3 months follow-up (after 6 months)
Secondary	Eye-tracking	eye-movements using eye-tracking	pre-intervention (at day 0)
Secondary	Eye-tracking	eye-movements using eye-tracking	immediately post-intervention (after 3 months)
Secondary	Eye-tracking	eye-movements using eye-tracking	at 3 months follow-up (after 6 months)
Secondary	Daily functioning questionnaires	Questionnaires evaluating daily functioning: Insight Question Inventory, (IQI), Pediatric Quality of Life Inventory (PedsQL), the Flemish cerebral visual impairment questionnaire (FCVIQ).	pre-intervention (at day 0)
Secondary	Daily functioning questionnaires	Questionnaires evaluating daily functioning: Insight Question Inventory, (IQI), Pediatric Quality of Life Inventory (PedsQL), the Flemish cerebral visual impairment questionnaire (FCVIQ).	immediately post-intervention (after 3 months)
Secondary	Daily functioning questionnaires	Questionnaires evaluating daily functioning: Insight Question Inventory, (IQI), Pediatric Quality of Life Inventory (PedsQL), the Flemish cerebral visual impairment questionnaire (FCVIQ).	at 3 months follow-up (after 6 months)
Secondary	Functional evaluation of visual perception	Change in an adapted Virtual Toybox (Bauer et al., 2008)	pre-intervention (at day 0)
Secondary	Functional evaluation of visual perception	Adapted Virtual Toybox (Bauer et al., 2008)	immediately post-intervention (after 3 months)
Secondary	Functional evaluation of visual perception	Adapted Virtual Toybox (Bauer et al., 2008)	at 3 months follow-up (after 6 months)