Autism Spectrum DisorderNCT06291532
Feasibility and Usability of a Virtual Reality System
A study testing Rehabilitation with VRRS and Conventional cognitive training in people with Autism Spectrum Disorder and Intellectual Disability, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
Intellectual disability (ID) and autism spectrum disorder (ASD) are often co-occurring neurodevelopmental disorders that require composite intervention. However, standardized rehabilitation programs presented several limitations due to behavioral problems and poor engagement in proposed activity. Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Autism Spectrum Disorder, Intellectual Disability
- What is being tested?
- Rehabilitation with VRRS and Conventional cognitive training
- 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 Apr 2023to 30 Sep 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 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- subjects diagnosed with ASD and ID, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- age between 6 and 40 years;
- cognitive level ≤75 Intellectual Quotient
- signed informed consent
Who cannot join
- subjects without diagnosis of ASD and ID, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- age not between 6 and 40 years;
- cognitive level >75 Intellectual Quotient
- unsigned informed consent
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: Feasibility and Usability of a Virtual Reality System to Improve Standardized Rehabilitation in Patients With Moderate Intellectual Disability and Severe Autism Spectrum Disorder
Intellectual disability (ID) and autism spectrum disorder (ASD) are often co-occurring neurodevelopmental disorders that require composite intervention. However, standardized rehabilitation programs presented several limitations due to behavioral problems and poor engagement in proposed activity. The Virtual Reality Rehabilitation System (VRRS) is a medical device is recognized as one of the most advanced systems to rehabilitate patients with motor, cognitive, linguistic and behavioral disorders. The use of VRRS offers the opportunity to adapting task parameters according to the patient's performance and the virtual system increases engagement and avoids boredom and frustration. the patients underwent a two months experimental intervention integrated into the regular activity of a semi-residential center for autistic adolescents and young adults.
- Conditions
- Autism Spectrum Disorder, Intellectual Disability
- Being tested
- Rehabilitation with VRRS, Conventional cognitive training
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation with VRRSDevice
The patients underwent an experimental intervention lasting two months (9 sessions lasting about 40 minutes) integrated into the regular activity of a semi-residential center for autistic adolescents and young adults.
The proposed exercises were 2D and the patient interacted with the scenarios through the touch screen. For all participants, the tasks were the same, but difficulty and duration varied according to the needs and goals to be achieved.
Conventional cognitive trainingBehavioural
Conventional cognitive training consisted of structured paper-and-pencil tasks and therapist-guided activities targeting multiple cognitive domains, including attention, visual-spatial processing, sustained attention, working memory, and problem-solving. These exercises were administered individually by a trained therapist and tailored to each participant's functional level. The intervention lasting two months (9 sessions, lasting about 40 minutes) integrated into regular activity of semi-residential center for autistic adolescents and young adults.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (EG) | Experimental | The group consists of patients diagnosed with autism spectrum disorder and intellectual disability who underwent treatment with VRRS Receives: Device: Rehabilitation with VRRS |
| Conventional Cognitive Training | Active comparator | Patients diagnosed with autism spectrum disorder and intellectual disability underwent to conventional cognitive training Receives: Behavioral: Conventional cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability questionnaire
The questionnaire used a 5-point ordinal scale, where 5 is the most favorable score and 1 is the least favorable score; the score 3 corresponds to "no opinion". The questionnaire will be completed by all therapists at the end of the treatment.
Measured: T0 (BASELINE) - T1 (SIX MONTHS)
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: screen attention time
During the execution of the exercise, the attention time maintained on the screen was recorded.
Measured: T0 (BASELINE) -T1 (SIX MONTHS)
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: the number of repetitions of the exercises.
During the execution of the exercise, the number of repetitions of the exercises was recorded
Measured: T0 (BASELINE) -T1 (SIX MONTHS)
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters:global scores for exercise.
The total scores obtained were recorded during the execution of the exercise.
Measured: T0 (BASELINE) -T1 (SIX MONTHS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Apr 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- Crossover
- 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
- Principal investigator, Francesca Cucinotta, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291532
- Sponsor's protocol ID
- VRRS01
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernard Paulais MA, Mazetto C, Thiebaut E, Nassif MC, Costa Coelho De Souza MT, Stefani AP, Blanc R, Gattegno MP, Aiad F, Sam N, Belal L, Fekih L, Kaye K, Contejean Y, Wendland J, Barthelemy C, Bonnet-Brilhault F, Adrien JL. Heterogeneities in Cognitive and Socio-Emotional Development in Children With Autism Spectrum Disorder and Severe Intellectual Disability as a Comorbidity. Front Psychiatry. 2019 Jul 19;10:508. doi: 10.3389/fpsyt.2019.00508. eCollection 2019.
PubMed 31396112De Luca R, Bonanno M, Rifici C, Pollicino P, Caminiti A, Morone G, Calabro RS. Does Non-Immersive Virtual Reality Improve Attention Processes in Severe Traumatic Brain Injury? Encouraging Data from a Pilot Study. Brain Sci. 2022 Sep 8;12(9):1211. doi: 10.3390/brainsci12091211.
PubMed 36138947
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Usability of a Virtual Reality System to Improve Standardized Rehabilitation in Patients With Moderate Intellectual Disability and Severe Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06291532
- Acronym / sponsor ID
- VRRS01
- Conditions
- Autism Spectrum Disorder, Intellectual Disability
- 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 Apr 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Mar 2024 (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.
Intellectual disability (ID) and autism spectrum disorder (ASD) are often co-occurring neurodevelopmental disorders that require composite intervention. However, standardized rehabilitation programs presented several limitations due to behavioral problems and poor engagement in proposed activity. The Virtual Reality Rehabilitation System (VRRS) is a medical device is recognized as one of the most advanced systems to rehabilitate patients with motor, cognitive, linguistic and behavioral disorders. The use of VRRS offers the opportunity to adapting task parameters according to the patient's performance and the virtual system increases engagement and avoids boredom and frustration. the patients underwent a two months experimental intervention integrated into the regular activity of a semi-residential center for autistic adolescents and young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group (EG) | Experimental | Device: Rehabilitation with VRRSThe group consists of patients diagnosed with autism spectrum disorder and intellectual disability who underwent treatment with VRRS |
| Conventional Cognitive Training | Active comparator | Behavioral: Conventional cognitive trainingPatients diagnosed with autism spectrum disorder and intellectual disability underwent to conventional cognitive training |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- subjects diagnosed with ASD and ID, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- age between 6 and 40 years;
- cognitive level ≤75 Intellectual Quotient
- signed informed consent
Key exclusion criteria (4 listed)
- subjects without diagnosis of ASD and ID, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- age not between 6 and 40 years;
- cognitive level >75 Intellectual Quotient
- unsigned informed consent
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 |
|---|---|---|
| Rehabilitation with VRRSThe patients underwent an experimental intervention lasting two months (9 sessions lasting about 40 minutes) integrated into the regular activity of a semi-residential center for autistic adolescents and young adults. The proposed exercises were 2D and the patient interacted with the scenarios through the touch screen. For all participants, the tasks were the same, but difficulty and duration varied according to the needs and goals to be achieved. | Device | Experimental Group (EG) |
| Conventional cognitive trainingConventional cognitive training consisted of structured paper-and-pencil tasks and therapist-guided activities targeting multiple cognitive domains, including attention, visual-spatial processing, sustained attention, working memory, and problem-solving. These exercises were administered individually by a trained therapist and tailored to each participant's functional level. The intervention lasting two months (9 sessions, lasting about 40 minutes) integrated into regular activity of semi-residential center for autistic adolescents and young adults. | Behavioural | Conventional Cognitive Training |
Primary outcome
Usability questionnaire
Time frame: T0 (BASELINE) - T1 (SIX MONTHS)
The questionnaire used a 5-point ordinal scale, where 5 is the most favorable score and 1 is the least favorable score; the score 3 corresponds to "no opinion". The questionnaire will be completed by all therapists at the end of the treatment.
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: screen attention time
Time frame: T0 (BASELINE) -T1 (SIX MONTHS)
During the execution of the exercise, the attention time maintained on the screen was recorded.
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: the number of repetitions of the exercises.
Time frame: T0 (BASELINE) -T1 (SIX MONTHS)
During the execution of the exercise, the number of repetitions of the exercises was recorded
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters:global scores for exercise.
Time frame: T0 (BASELINE) -T1 (SIX MONTHS)
The total scores obtained were recorded during the execution of the exercise.
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 8 Oct 2026.
- Background: PubMed 31396112Bernard Paulais MA, Mazetto C, Thiebaut E, Nassif MC, Costa Coelho De Souza MT, Stefani AP, Blanc R, Gattegno MP, Aiad F, Sam N, Belal L, Fekih L, Kaye K, Contejean Y, Wendland J, Barthelemy C, Bonnet-Brilhault F, Adrien JL. Heterogeneities in Cognitive and Socio-Emotional Development in Children With Autism Spectrum Disorder and Severe Intellectual Disability as a Comorbidity. Front Psychiatry. 2019 Jul 19;10:508. doi: 10.3389/fpsyt.2019.00508. eCollection 2019.
- Background: PubMed 36138947De Luca R, Bonanno M, Rifici C, Pollicino P, Caminiti A, Morone G, Calabro RS. Does Non-Immersive Virtual Reality Improve Attention Processes in Severe Traumatic Brain Injury? Encouraging Data from a Pilot Study. Brain Sci. 2022 Sep 8;12(9):1211. doi: 10.3390/brainsci12091211.
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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 Rehabilitation with VRRS and Conventional cognitive training in people with Autism Spectrum Disorder and Intellectual Disability, 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 4 inclusion and 4 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 8 Oct 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?
Usability questionnaire (time frame: T0 (BASELINE) - T1 (SIX MONTHS)). The study lists 4 primary outcomes in all. 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 NCT06291532, which also lists 2 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 8 Oct 2026.