Feasibility and Usability of a Virtual Reality System

NCT06291532 | Enrolling By Invitation

• 1 other identifier: VRRS01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Intellectual Disability

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Experimental Group (EG)

EXPERIMENTAL

The group consists of patients diagnosed with autism spectrum disorder and intellectual disability who underwent treatment with VRRS

Device: Rehabilitation with VRRS

Interventions

Rehabilitation with VRRS DEVICE

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.

Experimental Group (EG)

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, 98124, Italy

Location

Related 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.

  PMID: 31396112 BACKGROUND

• 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.

  PMID: 36138947 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 4, 2024
• Study Start: April 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

IT (1)