Quantitative Assessment of Static Balance in Children With Autism Spectrum Disorder Using VRRS
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Istituto per la Ricerca e l'Innovazione Biomedica
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Centre of Pressure (COP) displacement
概览
简要总结
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Withdrawn criteria: Participants will be considered withdrawn if any of the following occurs: (1) participant chooses to withdraw from the study at any time, (2) intolerable adverse effects, (3) major violation of the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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Autism;
排除标准
- •Motor deficits due to another clinical condition
研究组 & 干预措施
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.
干预措施: Virtual Reality Rehabilitation System (VRRS) in conjunction with a stabilometric balance platform (Other)
结局指标
主要结局
Centre of Pressure (COP) displacement
时间窗: 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.
Centre of Pressure (COP) velocity
时间窗: 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.
Centre of Pressure (COP) sway area
时间窗: 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.
次要结局
未报告次要终点
研究者
Flavia Marino
Head of Unit
Istituto per la Ricerca e l'Innovazione Biomedica