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临床试验/CTRI/2025/07/091727
CTRI/2025/07/091727尚未招募2 期

Effectiveness of Virtual and Augmented reality-based training versus conventional physiotherapy on sensorimotor skills in children with Autism spectrum disorder

Srilakshmi J1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2025年8月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
118
试验地点
1
主要终点
fine motor skill, in-hand-eye coordination, dexterity, and precision in tasks such as object manipulation and manual tasks

研究概览

简要总结

This study was conducted in  the Faculty of Physiotherapy pediatric outpatient department equipped with VR/AR systems. The aim was to compare the impact of immersive digital training methods with conventional physiotherapy on improving sensorimotor skills in children with Autism Spectrum Disorder (ASD). Children aged 6 to 12 years, diagnosed with ASD, who could walk independently and follow simple instructions, were included in the study. Exclusion criteria involved children with severe visual or hearing impairments, coexisting neurological conditions like epilepsy, recent orthopedic surgeries, or significant behavioral issues preventing VR participation. Participants were divided into two groups: one receiving virtual and augmented reality-based sensorimotor training, and the other undergoing conventional physiotherapy. Outcome measures focused on evaluating gross and fine motor skills (using tools like the AMAS), sensory integration abilities (assessed with scales such as the Sensory Profile), and  Biomarkers for functional performance,VABS to assess adaptive behavior; and the 6-minute walk test to assess endurance and walking ability before and after the intervention period.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children aged 6 to 12 years
  • Diagnosed with Autism Spectrum Disorder according to medical report and classified by ISAA 107 (Moderate)
  • Both genders.
  • Cognitive Functioning Level: Participants must possess a minimum level of cognitive functioning to engage with the VR training exercises.
  • FSIQ score of 70 or above.
  • Participants should have the ability to tolerate and use virtual reality technology.
  • Children who could walk independently and follow simple instructions.

排除标准

  • Participants with severe cognitive, behavioral, or clinical limitations that prevent them from following instructions and safely participating in group physical activity.
  • Who have undergone surgery or fractures in the last 6 months.
  • Parents self-reported mental illness or substance abuse.
  • Children with severe visual or hearing impairments
  • Coexisting neurological conditions like epilepsy 6.Recent orthopedic surgeries.

结局指标

主要结局

fine motor skill, in-hand-eye coordination, dexterity, and precision in tasks such as object manipulation and manual tasks

时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks

次要结局

  • To evaluate the effectiveness of virtual & augmented reality-based training versus conventional physiotherapy on salivary biomarkers, gross motor skill improvement, & fine motor skill development in children with ASD.(Baseline, 4 weeks, 8 weeks & 12 weeks)

研究者

发起方
Srilakshmi J
申办方类型
Other [other (self)]
责任方
Principal Investigator
主要研究者

Srilakshmi J

Faculty of Physiotherapy, Dr. M.G.R.Educational and Research Institute

研究点 (1)

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