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

February 16, 2026 updated by: IRCCS Centro Neurolesi Bonino Pulejo

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Adriana Piccolo, PSY
  • Phone Number: +3909060128256
  • Email: info@irccsme.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Behavioral: Treatment as usual
Participants will begin the Traditional CBT intervention without the use of virtual reality technology
Experimental: VRRS Intervention
Behavioral: vrrs

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nepsy
Time Frame: 6 weeks
NEPSY-II
6 weeks
tower of london
Time Frame: 6 weeks
6 weeks
CMF - Italian Assessment Battery for Metaphonological Skills
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Investigators

  • Principal Investigator: PICCOLO, IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy 98100

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 31, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vrrs25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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