Language Development DisordersNCT07438639
Virtual Reality-supported Language Intervention for Preschool Children With DLD
A study testing Virtual Reality Rehabilitation System (VRRS) and Taditional Speech Therapy in people with Language Development Disorders, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Language Development Disorders
- What is being tested?
- Virtual Reality Rehabilitation System (VRRS) and Taditional Speech Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Language Development Disorders
- Being tested
- Virtual Reality Rehabilitation System (VRRS), Taditional Speech Therapy
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 TherapyBehavioural
Standard speech-language therapy delivered in-person by certified therapists, targeting the same language domains with paper-based and interactive materials.
| Study group | Role | What they receive |
|---|---|---|
| VR-Supported Speech Therapy | Experimental | Children receive two 60-minute sessions per week for six months using the Virtual Reality Rehabilitation System (VRRS). Receives: Device: Virtual Reality Rehabilitation System (VRRS) |
| Traditional Speech Therapy | Active comparator | Children receive the same therapy schedule and goals through conventional speech-language sessions using printed materials, games, and verbal interaction. Receives: Behavioral: Taditional Speech Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Month 3
Secondary outcomes (1)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Feb 2023
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438639
- Sponsor's protocol ID
- VRRS_LOGO
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 37628335van 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.
PubMed 25938137De 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.
PubMed 42346830
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Efficacy of Virtual Reality-Supported Speech Therapy in Preschool Children With Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT07438639
- Acronym / sponsor ID
- VRRS_LOGO
- Conditions
- Language Development Disorders
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-Supported Speech Therapy | Experimental | Device: Virtual Reality Rehabilitation System (VRRS)Children receive two 60-minute sessions per week for six months using the Virtual Reality Rehabilitation System (VRRS). |
| Traditional Speech Therapy | Active comparator | Behavioral: Taditional Speech TherapyChildren receive the same therapy schedule and goals through conventional speech-language sessions using printed materials, games, and verbal interaction. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | VR-Supported Speech Therapy |
| Taditional Speech TherapyStandard speech-language therapy delivered in-person by certified therapists, targeting the same language domains with paper-based and interactive materials. | Behavioural | Traditional Speech Therapy |
Primary outcome
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.
1 secondary outcome
Griffiths III Scales
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 37628335Cappadona 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.
- Background: PubMed 25938137van 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.
- Derived from this study: PubMed 42346830De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Rehabilitation System (VRRS) and Taditional Speech Therapy in people with Language Development Disorders, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language Development Level Test (TVL) (time frame: Baseline and Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07438639, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.