Clinical trial NCT06152510: Static Balance in Children With Autism vs. Neurotypical Peers
Official title: Comparative Study of Static Balance Abilities in Children With Autism and Neurotypical Peers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autism
Autism Spectrum Disorder
Keywords: Autism
virtual reality
virtual reality rehabilitation system
postural control
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2023-11-30
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty children with Autism Spectrum Disorder (ASD) and 30 typically developing (TD) children will participate in the study. 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 Diagnostic and Statistical Manual, Fifth Edition (DSM-5) criteria from a licensed clinical child neuropsychiatrist but no established intellectual disability diagnosis. The TD children will recruit through advertisements in schools located close to the Institute. Informed consent will obtain from all subjects involved in the study.

Brief summary: The Virtual Reality Rehabilitation System (VRRS) is an innovative and sophisticated technology, aimed to generate immersive and interactive settings intended for therapeutic and evaluative objectives. Through the utilization of virtual reality 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.Understanding the nuanced motor abilities in children, particularly those with neurodevelopmental conditions like autism, is a critical area of research in pediatric rehabilitation. The significance of this research lies in comprehending the specific balance challenges experienced by children with autism spectrum disorder (ASD), a population often noted for motor coordination and balance difficulties. Because VRRS offers a controlled and engaging environment, this study seeks to provide a detailed analysis of static balance abilities in capabilities in children diagnosed with ASD in comparison to typically developing (TD) children. The study also wants to explore the efficacy of VRRS as an assessment tool for pediatric balance evaluations.The primary objective of this study is to highlight the distinctions in postural control between ASD and TD children, utilizing an objective quantification tool to delineate the differences between the two groups. This will be achieved through a group comparison study involving two distinct cohorts. The first group will comprise 30 school-aged children with ASD, while the second group will consist of 30 TD school-aged children. To evaluate postural control, both groups will participate in an activity utilizing the 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 in both groups, allowing for the observation and measurement of potential differences in stability and balance performance between children with ASD and their neurotypical counterparts.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Autism; QI ≥ 75

Exclusion Criteria:

* Motor deficits due to another clinical condition

Primary outcomes:
measure: Centre of Pressure (COP) displacement
timeFrame: The test needs approximately 3 minutes per child
measure: Centre of Pressure (COP) velocity
timeFrame: The test needs approximately 3 minutes per child
measure: Centre of Pressure (COP) sway area
timeFrame: The test needs approximately 3 minutes per child
measure: Movement Assessment Battery for Children - Second Edition (MABC-2)
timeFrame: The test needs approximately 40 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beani E, Filogna S, Martini G, Barzacchi V, Ferrari A, Guidi E, Menici V, Cioni G, Sgandurra G. Application of Virtual Reality Rehabilitation System for the assessment of postural control while standing in typical children and peers with neurodevelopmental disorders. Gait Posture. 2022 Feb;92:364-370. doi: 10.1016/j.gaitpost.2021.12.008. Epub 2021 Dec 10.
citation: Kaur M, M Srinivasan S, N Bhat A. Comparing motor performance, praxis, coordination, and interpersonal synchrony between children with and without Autism Spectrum Disorder (ASD). Res Dev Disabil. 2018 Jan;72:79-95. doi: 10.1016/j.ridd.2017.10.025. Epub 2017 Nov 6.
citation: Martini G, Beani E, Filogna S, Menici V, Cioni G, Battini R, Sgandurra G. New Technological Approach for the Evaluation of Postural Control Abilities in Children with Developmental Coordination Disorder. Children (Basel). 2022 Jun 26;9(7):957. doi: 10.3390/children9070957.