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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Language Development Disorders
• Intervention / Treatment: Device: Virtual Reality Rehabilitation System (VRRS); Behavioral: Taditional Speech Therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Messina, Italy
    • Francesca Cucinotta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR-Supported Speech Therapy; Children receive two 60-minute sessions per week for six months using the Virtual Reality Rehabilitation System (VRRS).	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.
Active Comparator: Traditional Speech Therapy; Children receive the same therapy schedule and goals through conventional speech-language sessions using printed materials, games, and verbal interaction.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Language Development Level Test (TVL)	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.	Baseline and Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Griffiths III Scales	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.	Baseline

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo

Publications and helpful links

General 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: 10.3390/children10081336.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Language Development Disorders
• Other Study ID Numbers: VRRS_LOGO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No