Static Balance in Children With Autism vs. Neurotypical Peers

Autism Spectrum Disorder Clinical Trial

Official title:

Comparative Study of Static Balance Abilities in Children With Autism and Neurotypical Peers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06152510
• Other study ID #: CNR-IRIB-PRO-2023-006
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: Chiara Failla
• Phone: +393921985644
• Email: chiara.failla[@]irib.cnr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Autism; QI = 75

Exclusion Criteria:

• Motor deficits due to another clinical condition

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• Virtual Reality Rehabilitation System
In a single session to evaluate postural control, both children with ASD and typically developing peers 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 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.

Locations

Country	Name	City	State
Italy	Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)	Messina

Sponsors (2)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica	Comune di Messina

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The test needs approximately 3 minutes per child
Primary	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.	The test needs approximately 3 minutes per child
Primary	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.	The test needs approximately 3 minutes per child
Primary	Movement Assessment Battery for Children - Second Edition (MABC-2)	The Movement Assessment Battery for Children - Second Edition (MABC-2) is an assessment test specifically developed for children from 3 to 16 years with motor function impairment. The tasks are divided by age range and organized into three sections: manual dexterity, aiming and catching and balance. Scores are provided in standard scores and percentiles and are interpreted by using a traffic light system: green light (scores above 15 percentile), meaning typical motor performances; yellow light (scores between 5 and 15 percentile), indicating a risk for motor impairment; red light (scores below 5 percentile), identifying a significant motor function impairment.	The test needs approximately 40 minutes.