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NCT Number: NCT07426289

Virtual Reality Supported Rehabilitation for Children's Executive and Metaphonological Skills

Executive functions and metaphonological skills are closely interconnected in supporting language development and learning processes.Investigating this relationship could offer new insights into how executive and metaphonological skills interact, supporting the development of integrated intervention strategies targeting both cognitive and linguistic domains.

This study aims to evaluate the effectiveness of a rehabilitation intervention using a virtual reality system (VRRS) in enhancing executive functions and monitoring metaphonological skills in children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD).The aim is to explore whether a semi-immersive digital cognitive training protocol can lead to measurable improvements in executive functions, and whether such improvements are associated with gains in metaphonological skills.

Participants will present deficits in executive functions and metaphonological skills and will undergo pre- and post-intervention assessments. These assessments include standardized neuropsychological and speech-language pathology tools designed to detect impairments in attention, inhibition, working memory, phonological awareness, and behavior in home and school settings.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion Criteria:

  • Children aged 8 to 12 years
  • Diagnosis of Attention Deficit Hyperactivity Disorder (ADHD)
  • Attending 3rd, 4th, or 5th grade of primary school
  • IQ greater than 70 (based on recent cognitive assessment)
  • Presence of executive function impairment and/or metaphonological difficulties
  • Availability of a baseline neuropsychological assessment (T0) completed within the last 3 months
  • Parental consent obtained

Exclusion criteria

  • Comorbid diagnosis of specific learning disorders (SLD)
  • Neurological, genetic, or psychiatric comorbidities other than ADHD
  • Uncorrected sensory impairments (vision or hearing)
  • Lack of informed consent

Treatment and study plan

vrrs

Behavioral

The intervention consists of 12 individual sessions using the Virtual Reality Rehabilitation System (VRRS).Each session lasts 45 minutes and is conducted twice a week over a 6-week period. The protocol is designed to stimulate and enhance executive functions such as working memory, inhibition, planning, and attention shifting in ADHD children.

The VRRS platform integrates semi-immersive, interactive cognitive exercises in a virtual environment, increasing engagement and motivation. Tasks are progressively adapted to the participant's level and performance.

Treatment as Usual

Behavioral

Participants will begin the Traditional CBT intervention without the use of virtual reality technology

Primary outcomes

  1. Nepsy

    Time frame: 6 weeks

    NEPSY-II

  2. tower of london

    Time frame: 6 weeks

  3. CMF - Italian Assessment Battery for Metaphonological Skills

    Time frame: 6 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Adriana Piccolo, PSY

CONTACT

[email protected]

+3909060128256

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

Evaluating the Effectiveness of a Virtual Reality Rehabilitation System (VRRS) Intervention on Executive Function Enhancement and Monitoring of Metaphonological Skills in ADHD Children

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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