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

NCT ID: NCT05014503

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-02
• Study Completion Date: 2024-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Adaptive version of the therapeutic game

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.

Group Type: EXPERIMENTAL

Adaptive Therapeutic gaming

Intervention Type: 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 version of the therapeutic game

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.

Group Type: ACTIVE_COMPARATOR

Non-adaptive Therapeutic gaming

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Els Ortibus, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven / KU Leuven

Locations

UZ Leuven

Leuven, Vlaams-brabant, Belgium

Countries

Belgium

Other Identifiers

s65773

Identifier Type: -

Identifier Source: org_study_id