An interventional study of Virtual Reality Rehabilitation System (VRRS) and Taditional Speech Therapy in Language Development Disorders, sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Enrolling by invitation at 1 site in Italy. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Not applicable, Interventional, and Treatment
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.
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's planned enrollment of 100 is above the median of 74 across 106 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →IRCCS Centro Neurolesi Bonino Pulejo is the lead sponsor of 67 studies on the registry; 31 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children receive two 60-minute sessions per week for six months using the Virtual Reality Rehabilitation System (VRRS).
Device: Virtual Reality Rehabilitation System (VRRS)
Children receive the same therapy schedule and goals through conventional speech-language sessions using printed materials, games, and verbal interaction.
Behavioral: Taditional Speech Therapy
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.
Standard speech-language therapy delivered in-person by certified therapists, targeting the same language domains with paper-based and interactive materials.
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.
Time frame: Baseline and Month 3
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.
Time frame: Baseline
Started Feb 2023 (actual). Primary completion is estimated for Nov 2026, 45 months after the start.
Of 72 non-industry interventional studies with no phase under Language Development Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 45 months is above that.
Counting every sponsor, half of 72 studies reached it within 30 months; a quarter within 19 and three quarters within 57.
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Language Development Disorders →
IRCCS Centro Neurolesi Bonino Pulejo