- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426289
Virtual Reality Supported Rehabilitation for Children's Executive and Metaphonological Skills
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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adriana Piccolo, PSY
- Phone Number: +3909060128256
- Email: info@irccsme.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
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
|
Participants will begin the Traditional CBT intervention without the use of virtual reality technology
|
|
Experimental: VRRS Intervention
|
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
Investigators
- Principal Investigator: PICCOLO, IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy 98100
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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