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Virtual Reality-supported Language Intervention for Preschool Children With DLD

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07438639
Enrollment
100
Registered
2026-02-27
Start date
2023-02-01
Completion date
2026-12-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Language Development Disorders

Brief summary

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

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.

BEHAVIORALTaditional Speech Therapy

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

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Language Development Level Test (TVL)Baseline and Month 3The 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

MeasureTime frameDescription
Griffiths III ScalesBaselineGeneral 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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 7, 2026