Menu
Not yet recruiting NCT07426289

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

No phase Interventional Attention Deficit Hyperactivity Disorder (ADHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vrrs, Treatment as usual.
Who it may be relevant to
Registry conditions: Attention Deficit Hyperactivity Disorder (ADHD). Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 pr
  • Behavioral Treatment as usual
    Participants will begin the Traditional CBT intervention without the use of virtual reality technology

Primary outcome measures

  • Nepsy [Time frame: 6 weeks]
  • tower of london [Time frame: 6 weeks]
  • CMF - Italian Assessment Battery for Metaphonological Skills [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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
  • 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

Identifiers

NCT: NCT07426289 · vrrs25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗