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

NCT05014503 | Completed DMC

• 1 other identifier: s65773
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Visual Impairment

Keywords

Cerebral Visual Impairment; Training; Rehabilitation; Therapeutic gaming; Adaptive therapy; Randomized Controlled Trial; Visual Perception

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (15)

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

  pre-intervention (at day 0)

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

  immediately post-intervention (after 3 months)

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

  at 3 months follow-up (after 6 months)

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

  pre-intervention (at day 0)

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

  immediately post-intervention (after 3 months)

Study Arms (2)

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.

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.

Other: Non-adaptive Therapeutic gaming

Interventions

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.

Adaptive version of the therapeutic game

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.

Non-adaptive version of the therapeutic game

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Vrije Universiteit Brussel: collaborator
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Blindness, Cortical

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Els Ortibus, MD PhD

  UZ Leuven / KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participating children, their parents/caretakers as well as their guiding therapist will be blinded for allocation to the treatment condition Assessors will be blind to the treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomized controlled trial

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 20, 2021
• Study Start: January 2, 2022
• Primary Completion: May 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)