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

NCT07426289 | Not Yet Recruiting DMC

• 1 other identifier: vrrs25
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (3)

• Nepsy

  NEPSY-II

  6 weeks

• tower of london

  6 weeks

• CMF - Italian Assessment Battery for Metaphonological Skills

  6 weeks

Study Arms (2)

VRRS Intervention

EXPERIMENTAL

Behavioral: vrrs

control group

ACTIVE COMPARATOR

Behavioral: Treatment as usual

Interventions

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.

VRRS Intervention

Treatment as usual BEHAVIORAL

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

control group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Related Publications (3)

• Shokrkon A, Nicoladis E. The Directionality of the Relationship Between Executive Functions and Language Skills: A Literature Review. Front Psychol. 2022 Jul 19;13:848696. doi: 10.3389/fpsyg.2022.848696. eCollection 2022.

  PMID: 35928417 RESULT

• Menezes A, Dias NM, Trevisan BT, Carreiro LR, Seabra AG. Intervention for executive functions in attention deficit and hyperactivity disorder. Arq Neuropsiquiatr. 2015 Mar;73(3):227-36. doi: 10.1590/0004-282X20140225.

  PMID: 25807129 RESULT

• Corrigan N, Pasarelu CR, Voinescu A. Immersive virtual reality for improving cognitive deficits in children with ADHD: a systematic review and meta-analysis. Virtual Real. 2023 Feb 18:1-20. doi: 10.1007/s10055-023-00768-1. Online ahead of print.

  PMID: 36845650 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• PICCOLO

  IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy 98100

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Piccolo, PSY

CONTACT

+3909060128256; info@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02