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Feasibility and Usability of a Virtual Reality System

Feasibility and Usability of a Virtual Reality System to Improve Standardized Rehabilitation in Patients With Moderate Intellectual Disability and Severe Autism Spectrum Disorder

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06291532
Enrollment
100
Registered
2024-03-04
Start date
2023-04-01
Completion date
2025-09-30
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Intellectual Disability

Brief 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.

Interventions

DEVICERehabilitation 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.

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Usability questionnaireT0 (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 timeT0 (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.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.T0 (BASELINE) -T1 (SIX MONTHS)The total scores obtained were recorded during the execution of the exercise.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026