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Clinical Trials/NCT06291532
NCT06291532
Enrolling by Invitation
N/A

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

IRCCS Centro Neurolesi "Bonino-Pulejo"1 site in 1 country100 target enrollmentApril 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Enrollment
100
Locations
1
Primary Endpoint
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: screen attention time
Status
Enrolling by Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
September 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Francesca Cucinotta

Principal Investigator

IRCCS Centro Neurolesi "Bonino-Pulejo"

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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:global scores for exercise.

Time Frame: T0 (BASELINE) -T1 (SIX MONTHS)

The total scores obtained were recorded during the execution of the exercise.

Study Sites (1)

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