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Enrolling by invitation NCT07438639

Virtual Reality-supported Language Intervention for Preschool Children With DLD

No phase Interventional Language Development Disorders

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: Virtual Reality Rehabilitation System (VRRS), Taditional Speech Therapy.
Who it may be relevant to
Registry conditions: Language Development Disorders. Basic parameters: 3 years — 8 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
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized Controlled Trial on the Efficacy of Virtual Reality-Supported Speech Therapy in Preschool Children With Developmental Language Disorder

Overview

This study aims to test the effectiveness of virtual reality-supported speech therapy in improving basic language skills in children aged 3 to 6 years diagnosed with Developmental Language Disorder (DLD). Participants are randomly assigned to either traditional speech therapy or virtual reality-supported therapy, with the same frequency and duration of intervention. Language outcomes are assessed before and after treatment using the Language development level test (TVL), a standardized assessment of Italian for preschoolers. The study adopts a randomized controlled design with individualized, goal-oriented therapy delivered by certified speech-language pathologists.

Interventions

  • Device Virtual Reality Rehabilitation System (VRRS)
    The VRRS delivers personalized language therapy exercises via touchscreen interface. Activities target receptive language, repetition, naming, and spontaneous language production. All sessions are conducted by trained speech-language pathologists in accordance with standardized therapeutic protocols.
  • Behavioral Taditional Speech Therapy
    Standard speech-language therapy delivered in-person by certified therapists, targeting the same language domains with paper-based and interactive materials.

Primary outcome measures

  • Language Development Level Test (TVL) [Time frame: Baseline and Month 3]
Secondary outcome measures (1)
  • Griffiths III Scales [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Age between 3 and 6 years at enrollment
  • Clinical diagnosis of Developmental Language Disorder (DLD) based on DSM-5 and standardized language assessments
  • Developmental Quotient (DQ) > 70 on the Griffiths III Scales
  • Good general health without neurological or psychiatric comorbidities
  • Informed consent signed by a parent or legal guardian

Exclusion criteria

  • Age not between 3 and 6 years
  • Lack of clinical diagnosis of Developmental Language Disorder (DLD)
  • Developmental Quotient (DQ) < 70 on the Griffiths Scale III
  • Presence of neurological or psychiatric comorbidities
  • Lack of signed informed consent from a parent or legal guardian

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
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Francesca Cucinotta — Messina

Publications

  • Cappadona I, Ielo A, La Fauci M, Tresoldi M, Settimo C, De Cola MC, Muratore R, De Domenico C, Di Cara M, Corallo F, Tripodi E, Impallomeni C, Quartarone A, Cucinotta F. Feasibility and Effectiveness of Speech Intervention Implemented with a Virtual Reality System in Children with Developmental Language Disorders: A Pilot Randomized Control Trial. Children (Basel). 2023 Aug 1;10(8):1336. doi: 10.3 PMID 37628335
  • van Vuuren S, Cherney LR. A Virtual Therapist for Speech and Language Therapy. Intell Virtual Agents. 2014 Jan 1;8637:438-448. doi: 10.1007/978-3-319-09767-1_55. PMID 25938137
  • De Domenico C, La Fauci M, Mancuso N, Caputo M, Di Cara M, Piccolo A, Fulgenzi A, Borzelli D, Impallomeni C, Tripodi E, Calabro RS, Quartarone A, Cucinotta F. Virtual Reality-Supported Speech Therapy in Children with Developmental Language Disorder: A Randomized Controlled Trial. Med Sci (Basel). 2026 Jun 5;14(2):291. doi: 10.3390/medsci14020291. PMID 42346830

Identifiers

NCT: NCT07438639 · VRRS_LOGO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗