Clinical trial NCT05014503: A Computerized, Adaptive Therapeutic Gaming Approach Training Visual Perceptual Skills in Children With CVI
Official title: A Randomized Controlled Trial to Evaluate the Effectiveness of a Computerized, Adaptive Therapy Approach for Children With Cerebral Visual Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Visual Impairment
Keywords: Cerebral Visual Impairment
Training
Rehabilitation
Therapeutic gaming
Adaptive therapy
Randomized Controlled Trial
Visual Perception
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: Fund for Scientific Research, Flanders, Belgium
First posted: 2021-08-20
Enrollment: 73
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind, randomized controlled trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Perceptual Profile
timeFrame: pre-intervention (Day 0)
measure: Visual Perceptual Profile
timeFrame: immediately post-intervention (after 3 months of training)
measure: Visual Perceptual Profile
timeFrame: at 3 months follow-up (after 6 months)
Secondary outcomes:
measure: Visual Perceptual Tests (individual test scores) (younger children, age 3-6y)
timeFrame: pre-intervention (at day 0)
measure: Visual Perceptual Tests (individual test scores) (younger children, dev age 3-6y)
timeFrame: immediately post-intervention (after 3 months)
measure: Visual Perceptual Tests (individual test scores) (younger children, age 3-6y)
timeFrame: at 3 months follow-up (after 6 months)
measure: Visual Perceptual Tests (individual test scores) (older children, age 6-12y)
timeFrame: pre-intervention (at day 0)
measure: Visual Perceptual Tests (individual test scores) (older children, aged 6-12y)
timeFrame: immediately post-intervention (after 3 months)
measure: Visual Perceptual Tests (individual test scores) (older children, aged 6-12y)
timeFrame: at 3 months follow-up (after 6 months)
measure: Eye-tracking
timeFrame: pre-intervention (at day 0)
measure: Eye-tracking
timeFrame: immediately post-intervention (after 3 months)
measure: Eye-tracking
timeFrame: at 3 months follow-up (after 6 months)
measure: Daily functioning questionnaires
timeFrame: pre-intervention (at day 0)
measure: Daily functioning questionnaires
timeFrame: immediately post-intervention (after 3 months)
measure: Daily functioning questionnaires
timeFrame: at 3 months follow-up (after 6 months)
measure: Functional evaluation of visual perception
timeFrame: pre-intervention (at day 0)
measure: Functional evaluation of visual perception
timeFrame: immediately post-intervention (after 3 months)
measure: Functional evaluation of visual perception
timeFrame: at 3 months follow-up (after 6 months)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-brabant
Study officials:
affiliation: UZ Leuven / KU Leuven
name: Els Ortibus, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: