Feasibility and Usability of a Virtual Reality System

Autism Spectrum Disorder Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06291532
• Other study ID #: VRRS01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: February 2024
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 40 Years

Eligibility

Inclusion criteria:

• 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 <65 Intellectual Quotient

• signed informed consent

Exclusion criteria:

• 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 >65 Intellectual Quotient

• unsigned informed consent

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Intellectual Disability

Intervention

Device:
• Rehabilitation with VRRS
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.

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi Bonino Pulejo	Messina

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

De 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	T0 (BASELINE) - T1 (SIX MONTHS)
Primary	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.	T0 (BASELINE) -T1 (SIX MONTHS)
Primary	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	T0 (BASELINE) -T1 (SIX MONTHS)
Primary	Virtual Reality Rehabilitation System (VRRS) electromedical device parameters:global scores for exercise.	The total scores obtained were recorded during the execution of the exercise.	T0 (BASELINE) -T1 (SIX MONTHS)