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NCT Number: NCT07403396

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Withdrawn criteria: Participants will be considered withdrawn if any of the following occurs: (1) participant chooses to withdraw from the study at any time, (2) intolerable adverse effects, (3) major violation of the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

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Key information

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, 98164, Italy

Location status: Recruiting

Location contact

Anna Meduri

SUB_INVESTIGATOR

Chiara Failla

SUB_INVESTIGATOR

Chiara Marraffa

SUB_INVESTIGATOR

Chiara Rando

SUB_INVESTIGATOR

Flavia Marino

PRINCIPAL_INVESTIGATOR

Germana Doria

SUB_INVESTIGATOR

Giovanni Pioggia

SUB_INVESTIGATOR

Ileana Scarcella

SUB_INVESTIGATOR

Paola Chilà

SUB_INVESTIGATOR

Roberta Minutoli

SUB_INVESTIGATOR

chiara failla

CONTACT

[email protected]

+393921985644

maria valeria Maiorana

CONTACT

[email protected]

+393285856656

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Autism;
  • QI ≥ 60

Exclusion criteria

  • Motor deficits due to another clinical condition

Treatment and study plan

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

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Failla

CONTACT

[email protected]

+393921985644

Giovanni Pioggia

CONTACT

[email protected]

+393203390892

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Collaborators

  • Messina, Italy

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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