A Randomized Controlled Trial to Evaluate the Effectiveness of a Computerized, Adaptive Therapy Approach for Children With Cerebral Visual Impairment
Trial ID: NCT05014503
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-01-02
Completion date: 2024-12-31
Sponsor: Universitaire Ziekenhuizen KU Leuven
Collaborators: Vrije Universiteit Brussel; Fund for Scientific Research, Flanders, Belgium
Conditions: Cerebral Visual Impairment
Interventions: Adaptive Therapeutic gaming; Non-adaptive Therapeutic gaming
Locations: UZ Leuven
Countries: Belgium
Enrollment: 73
Age range: 3 Years - 12 Years
Sex: ALL

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.

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

Outcomes:
Visual Perceptual Profile; Visual Perceptual Profile; Visual Perceptual Profile