NCT07403396 Static Balance Assessment in Children With ASD Using VRRS
| NCT ID | NCT07403396 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto per la Ricerca e l'Innovazione Biomedica |
| Condition | Autism |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-01-02 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-01-02 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Withdrawn criteria: Participants will be considered withdrawn if any of the following occurs: (1) participant chooses to withdraw from the study at any time, (2) intolerable adverse effects, (3) major violation of the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.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Autism; * QI ≥ 60 Exclusion Criteria: * Motor deficits due to another clinical condition
Contact & Investigator
Flavia Marino
PRINCIPAL INVESTIGATOR
Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) Messina, Italy, 98164
Frequently Asked Questions
Who can join the NCT07403396 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 13 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07403396 currently recruiting?
Yes, NCT07403396 is actively recruiting participants. Contact the research team at chiara.failla@irib.cnr.it for enrollment information.
Where is the NCT07403396 trial being conducted?
This trial is being conducted at Messina, Italy.
Who is sponsoring the NCT07403396 clinical trial?
NCT07403396 is sponsored by Istituto per la Ricerca e l'Innovazione Biomedica. The principal investigator is Flavia Marino at Italy Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) Messina, Italy, 98164. The trial plans to enroll 50 participants.