NCT05014503

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-01-02
• Primary completion: 2024-05-30
• Completion: 2024-12-31
• First posted: 2021-08-20
• Last updated: 2025-03-18

Locations

1 site across 1 country: Belgium