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NCT Number: NCT07438639

Virtual Reality-supported Language Intervention for Preschool Children With DLD

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.

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Key information

Conditions

Language Development Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Francesca Cucinotta

Messina, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Rehabilitation System (VRRS)

Device

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.

Taditional Speech Therapy

Behavioral

Standard speech-language therapy delivered in-person by certified therapists, targeting the same language domains with paper-based and interactive materials.

Primary outcomes

  1. Language Development Level Test (TVL)

    Time frame: Baseline and Month 3

    The Test of Verbalization and Language Development is a standardized tool designed to assess various aspects of language development, including verbal production, comprehension, sentence construction, phonological accuracy, and morphosyntactic abilities. The weighted score ranges from 0 to 10, with higher scores indicating better language development.

Secondary outcomes

  1. Griffiths III Scales

    Time frame: Baseline

    General cognitive development will be assessed using the Griffiths III Scales of Child Development. The Global Developmental Quotient, DQ, has a possible range from 50 to 150, with higher scores indicating better developmental and cognitive functioning. The DQ will be used as an index of overall cognitive functioning and as a potential moderator in the analysis of language outcomes.

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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