Feasibility and Usability of a Virtual Reality System

Not Applicable

• Conditions: Intellectual Disability; Autism Spectrum Disorder
• Interventions: Device: Rehabilitation with VRRS

• Registration Number: NCT06291532
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group (EG)	Rehabilitation with VRRS	The group consists of patients diagnosed with autism spectrum disorder and intellectual disability who underwent treatment with VRRS

Primary Outcome Measures

Name	Time	Method
Virtual Reality Rehabilitation System (VRRS) electromedical device parameters: screen attention time	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.	T0 (BASELINE) -T1 (SIX MONTHS)	During the execution of the exercise, the number of repetitions of the exercises was recorded
Usability questionnaire	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.	T0 (BASELINE) -T1 (SIX MONTHS)	The total scores obtained were recorded during the execution of the exercise.

Trial Locations

Locations (1)

IRCCS Centro Neurolesi Bonino Pulejo; 🇮🇹 Messina, Italy