Cognitive Training in Virtual Reality for Autism

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Study ID
NCT07643649
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental Group — DEVICE
    During every single session, each participant will engage in the selected tasks for approximately five minutes per exercise through the use of VRRS, in order to specifically stimulate the different target cognitive functions (visual attention, executive functions, and visuo-spatial memory)
  • Control Group — OTHER
    During every single session, each participant will engage in the selected tasks with objectives equivalent to those of the experimental group, but without the use of virtual reality, instead employing traditional methods and paper-and-pencil activities.

Study Details

The Virtual Reality Rehabilitation System (VRRS) is an innovative tool for motor and cognitive rehabilitation that has shown promising results in developmental populations, with evidence of feasibility, safety, acceptability, and positive effects on attention, executive functions, and learning-related processes. Its playful and motivating features, together with the possibility of tailoring task difficulty and delivering intensive training in a controlled environment, make VRRS a promising intervention for children with autism spectrum disorder (ASD), who frequently present weaknesses in visual attention, executive functioning, and visuospatial memory. This randomized controlled trial aims to evaluate the efficacy of a VRRS-based cognitive training program in improving visual attention, executive functions, and visuospatial memory in children with ASD, compared with an active control intervention based on conventional cognitive training. Children aged 4 to 6 years 11 months with ASD, non-verbal IQ \>70, and no severe neurological or sensory comorbidities will be enrolled and randomly assigned to the experimental or control group. The intervention will consist of two 45-minute sessions per week for 12 weeks. VRRS training will include individualized tasks targeting the selected cognitive domains, with adjustable difficulty, execution time, and repetitions. Assessments will be conducted at baseline (T0) and post-intervention (T1). At baseline, non-verbal cognitive functioning will be assessed using Leiter International Performance Scale, Third Edition (LEITER-3), while attention, executive functions, and visuospatial memory will be measured using Preschool Executive Functions Assessment Battery (FE-PS), LEITER-3 attention and memory tasks, Developmental Neuropsychological Assessment - Second Edition (NEPSY-II) (Memory for Designs), and Behavior rating inventory of executive function-preschool version (BRIEF-P). The same battery will be repeated after training to compare pre- and post-intervention scores and estimate the relative efficacy of the two approaches. It is hypothesized that children receiving VRRS-based training will show greater improvements in the targeted cognitive functions than those receiving conventional training, supporting the clinical utility of virtual reality as an effective and engaging rehabilitation approach for children with ASD.

Key Dates

First listed
Jun 11, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group with VRRS
    Fifteen children with a diagnosis of autism spectrum disorder will undergo training to enhance Executive Functions, Visual Attention, Visuo-Spatial Memory through the use of the Virtual Reality Rehabilitation System (VRRS).
  • Other: Control Group without VRRS
    Fifteen children with a diagnosis of autism spectrum disorder will undergo traditional training to enhance Executive Functions, Visual Attention, Visuo-Spatial Memory through the use of paper-pencil tools and cognitive tasks.

Primary Outcome Measure

Leiter International Performance Scale, Third Edition (LEITER 3) [ Time Frame: The evaluation session will be scheduled at the beginning (T0) and at the end (T1) of the intervention. The test needs approximately 20-45 minutes to complete. ]

Central Contacts

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