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临床试验/NCT07341204
NCT07341204尚未招募不适用

Improvement of Sustained Attention Through Immersive Virtual Reality in Neurodivergent Children

New York Institute of Technology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
RightEye Assessment:

研究概览

简要总结

The goal of this study is to determine whether playing a virtual reality (VR) game can help neurodivergent children pay attention for extended periods. The study includes children ages 9 to 18 who have autism, ADHD, learning differences, or movement coordination challenges. The program lasts for 6 weeks. During this period, children will play a VR game twice per week, with each session lasting 25 minutes.

详细描述

The purpose of this quasi-experimental study is to investigate the impact of an immersive virtual reality (VR) game intervention on sustained attention in neurodivergent children aged 9 to 18 years. This project aligns with previous study dosages designed as a 6-week program targeting children diagnosed with autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), specific learning disorder (SLD), or developmental coordination disorder (DCD) (neurodivergent disorders). Participants will be recruited through convenience sampling in the local community and will participate in two 25-minute VR sessions per week for 6 weeks.

This study examines the effectiveness of a VR-based attention-training program by comparing pre- and post-intervention data using the Test of Variables of Attention (TOVA) and the Right Eye assessment. Repeated-measures ANOVA will be used to evaluate changes in sustained attention, including omission rates and response times. The findings will provide insight into how immersive VR games can enhance attention and engagement in daily activities among neurodivergent children, thereby facilitating the integration of technology-based interventions into therapeutic practice.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of ASD, ADHD, SLD, or DCD confirmed by a licensed clinician or documented in medical/educational records (DSM-5 or equivalent).
  • Parent/guardian consent and participant assent (age-appropriate).
  • Ability to follow simple verbal instructions and to participate in 25-minute VR sessions twice weekly for 6 weeks.
  • Stable medication regimen for attention- or behavior-related medications for ≥4 weeks prior to baseline (or not taking such medications).
  • Visual and auditory ability adequate for VR tasks (with or without usual corrective lenses/hearing aids).
  • Availability to attend all scheduled sessions at the clinical site across the 6-week period.

排除标准

  • History of photosensitive epilepsy or any uncontrolled seizure disorder.
  • Severe intellectual disability or severe communication impairment that prevents understanding/participation (e.g., non-responsive to simple commands required by the VR tasks).
  • Severe visual, auditory, or motor impairment that prevents safe or functional use of the VR system (e.g., inability to hold controllers or view the headset even with correction).
  • Recent (within 6 months) significant brain injury or neurosurgery. Significant history of motion sickness, severe vestibular disorder, or prior intolerance to immersive VR.
  • Any medical or implanted device contraindicated for VR/headset use (if applicable).

研究组 & 干预措施

Does participation in a 6-week VR-based program improve attentional skills in neurodiverse children?

Experimental

The research design comprises a nonequivalent quasi-experimental, multi-group pre- and post-test design (neurodivergent and neurotypical). The pre-test and post-test will consist of the Test of Variables of Attention (TOVA) and the RightEye assessment. These measures will be administered at the clinical site (ISF). The intervention consists of two 25-minute VR sessions per week for 6 weeks.

干预措施: Virtual Reality (Behavioral)

结局指标

主要结局

RightEye Assessment:

时间窗: Individual tests: 60 seconds (e.g., saccades) to 4-5 minutes (e.g., reaction time or pursuit tasks). Total session: 15-20 minutes, including 1-2 minutes for 9-point calibration and setup.

The RightEye system uses an infrared camera-based sensor bar attached to a monitor to objectively measure and analyze eye movements in real-time. It quantifies changes in attention-related oculomotor functions, including saccadic accuracy, smooth pursuit, reaction time, distractibility, and sustained attention. These metrics provide objective biomarkers for inattention and impulsivity, supporting occupational therapy goals of enhancing visual-motor integration, executive function, and participation in daily activities like reading or classroom engagement.

Test of Variables of Attention (TOVA)

时间窗: Standard visual test: 21.6 minutes (4 quarters of 5.4 minutes). Full session: 30-45 minutes (setup/review); short form for younger children (10.8 minutes; used for ages 9+).

The TOVA objectively measures sustained attention and inhibitory control via responses to visual stimuli (targets vs. non-targets). In this study, the visual TOVA will assess pre- and post-VR changes in attention in children with neurodevelopmental conditions, targeting omission errors, commission errors, response time, and response time variability.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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