Static Balance Assessment in Children With ASD Using VRRS

February 4, 2026 updated by: Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica

Quantitative Assessment of Static Balance in Children With Autism Spectrum Disorder Using VRRS

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Withdrawn criteria: Participants will be considered withdrawn if any of the following occurs: (1) participant chooses to withdraw from the study at any time, (2) intolerable adverse effects, (3) major violation of the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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Messina, Italy, 98164
        • Recruiting
        • Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
        • Principal Investigator:
          • Flavia Marino
        • Sub-Investigator:
          • Giovanni Pioggia
        • Sub-Investigator:
          • Paola Chilà
        • Sub-Investigator:
          • Roberta Minutoli
        • Sub-Investigator:
          • Chiara Failla
        • Sub-Investigator:
          • Germana Doria
        • Sub-Investigator:
          • Ileana Scarcella
        • Sub-Investigator:
          • Chiara Rando
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Anna Meduri
        • Sub-Investigator:
          • Chiara Marraffa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • Diagnosis of Autism;
  • QI ≥ 60

Exclusion Criteria:

  • Motor deficits due to another clinical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with autism spectrum condition
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Centre of Pressure (COP) displacement
Time Frame: The test needs approximately 3 minutes per child
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.
The test needs approximately 3 minutes per child
Centre of Pressure (COP) velocity
Time Frame: The test needs approximately 3 minutes per child
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.
The test needs approximately 3 minutes per child
Centre of Pressure (COP) sway area
Time Frame: The test needs approximately 3 minutes per child
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.
The test needs approximately 3 minutes per child

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Collaborators

Messina, Italy

Investigators

  • Principal Investigator: Flavia Marino, Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) Messina, Italy, 98164

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2026

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNR-IRIB-PRO-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism Spectrum Disorder

Clinical Trials on Virtual Reality Rehabilitation System (VRRS) in conjunction with a stabilometric balance platform

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe