An observational study in Autism and Autism Spectrum Disorder, sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. Recruiting at 1 site in Italy. Open to participants aged 6 Years to 13 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Istituto per la Ricerca e l'Innovazione Biomedica · Observational
Children with autism spectrum disorder (ASD) often exhibit postural and balance difficulties, which can impact daily functioning and motor development. Quantitative assessment using Virtual Reality Rehabilitation System (VRRS) provides precise measurements to better understand these deficits and their potential relationship with cognitive functioning. This observational trial aims to evaluate static balance in children with ASD aged 6-10 years. A total of 50 participants were enrolled, with 10 children in each age group. Static balance was assessed using the VRRS and a specific balance task, measuring 13 quantitative parameters including Mean Distance Centre of Pressure (MD_COP), Root Mean Square of Distance (RMS), Total Excursion (ESC), Velocity (VEL) , and Sway area (SWAY). Cognitive functioning was also recorded using standardized IQ assessments to explore correlations between balance performance and cognitive abilities. All data were stored in a dedicated database for analysis.
Participant recruitment: Children diagnosed with ASD will be recruited from the clinical facilities of the Institute for Biomedical Research and Innovation of the National Research Council of Italy (IRIB-CNR) in Messina as part of an ongoing research program.
Withdrawn criteria: Participants will be considered withdrawn if any of the following occurs: (1) participant chooses to withdraw from the study at any time, (2) intolerable adverse effects, (3) major violation of the study protocol, and (4) other circumstances that would endanger the health of the subject if he/she would to continue his/her participation in the trial.
Virtual Reality Rehabilitation system: The VRRS, a sophisticated technological innovation, aims to generate immersive and interactive settings intended for therapeutic and evaluative objectives. Through the utilization of virtual reality (VR) technology, it constructs diverse scenarios, tasks, and activities in a controlled digital environment, fostering engagement. Primarily crafted for rehabilitation purposes, the VRRS features adaptable programs addressing various therapeutic requirements, encompassing motor skill enhancement, cognitive challenges, and assessments related to balance.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 50 is below the median of 101 across 189 observational studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Istituto per la Ricerca e l'Innovazione Biomedica is the lead sponsor of 47 studies on the registry; 29 are open to participants now.
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Fifty children with ASD. The children with ASD will be recruited and tested at the clinical facilities of the Institute for Biomedical Research and Innovation of the National Research Council of Italy (IRIB-CNR) in Messina. To be included in the study the child needs to have an ASD diagnosis based on the DSM-5 criteria from a licensed clinical child neuropsychiatrist but no established intellectual disability diagnosis.
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Exclusion Criteria:
Fifty ASD children aged 6 to 13 years, IQ \> 60, in the absence of motor deficits due to another clinical condition.
Other: Virtual Reality Rehabilitation System (VRRS) in conjunction with a stabilometric balance platform
In a single session to evaluate postural control children with ASD will participate in an activity utilizing the Virtual Reality Rehabilitation System (VRRS) in conjunction with a stabilometric balance platform. During the assessment task, participants will stand on the balance platform with their eyes open, focusing on a fixed point displayed on the VRRS screen for a duration of one minute. This process will be repeated three times for each participant. The combined use of VRRS and the stabilometric balance platform aims to provide a comprehensive evaluation of postural control abilities.
Centre of Pressure (COP) displacement
The Virtual Reality Rehabilitation system (VRRS; Khymeia, Italy) is an innovative system based on the concept of augmented feedback. It consists of devices for clinical use and a tablet for home-based telerehabilitation, which can be remotely managed. Different peripherals can be connected via USB to the VRRS, including a stabilometric balance platform. It is a force plate (80 ×55 cm) able to detect forces in the z-direction and the Centre of Pressure (COP) displacement in millimeter (mm). The COP displacement is the distance and direction that COP moves from a reference point or position, in the anterior-posterior (AP) and medial-lateral (ML) direction, thanks to the four load cells integrated into the balance platform. Moreover, a dedicated software can be used to calibrate the balance platform which will allow the estimation of static postural data. After each measurement, a report containing a summary of the data can be exported through the dedicated software.
Time frame: The test needs approximately 3 minutes per child
Centre of Pressure (COP) velocity
The Virtual Reality Rehabilitation system (VRRS; Khymeia, Italy) is an innovative system based on the concept of augmented feedback. It consists of devices for clinical use and a tablet for home-based telerehabilitation, which can be remotely managed. Different peripherals can be connected via USB to the VRRS, including a stabilometric balance platform. It is a force plate (80 ×55 cm) able to detect Centre of Pressure (COP) velocity in millimeter per second (mm/s), a sensitive measure to detect changes in postural control.
Time frame: The test needs approximately 3 minutes per child
Centre of Pressure (COP) sway area
The Virtual Reality Rehabilitation system (VRRS; Khymeia, Italy) is an innovative system based on the concept of augmented feedback. It consists of devices for clinical use and a tablet for home-based telerehabilitation, which can be remotely managed. Different peripherals can be connected via USB to the VRRS, including a stabilometric balance platform. It is a force plate (80 ×55 cm) able to detect the Centre of Pressure (COP) sway area in square millimeter per second (mm2 /s). Sway area is the area enclosed by the COP trajectory per unit time.
Time frame: The test needs approximately 3 minutes per child
Plan to share: No
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Started Jan 2026 (actual). Primary completion is estimated for Mar 2026, 2 months after the start.
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Istituto per la Ricerca e l'Innovazione Biomedica