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临床试验/NCT04276571
NCT04276571已完成不适用

EMPATIA@Lecco- Balance Rehabilitation of Autistic Children With Virtual rEality

IRCCS Eugenio Medea2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
experimental balance assessment

研究概览

简要总结

The general objective of this project is to investigate the possible efficacy of a training based on proprioceptive and visual feedback carried out with the GRAIL (Motekforce Link) virtual reality environment on postural control and balance skills of school-aged children with clinical diagnosis of ASD.

研究设计

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

入排标准

年龄范围
7 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • a clinical diagnosis of ASD
  • All participants were required to have estimated FSIQ of 80 or above

排除标准

  • using any stimulant or non-stimulant medication that affects the central nervous system
  • having an identified genetic disorder
  • having vision or hearing problems
  • suffering from chronic or acute medical illness
  • presence of epilepsy

结局指标

主要结局

experimental balance assessment

时间窗: approximately 6 weeks after starting the intervention

Balance assessment through the evaluation (with both open and closed eyes) of the center of pression using the GRAIL platform

Movement Assessment Battery for Children 2 (MABC2) (Henderson et al., 2007).

时间窗: approximately 6 weeks after starting the intervention

The MABC2 consists of eight subtests that evaluate three components of motor proficiency: manual dexterity, ball skills, and static and dynamic balance. For the MABC2, higher scores are indicative of better motor performance.

次要结局

  • assessment of overground balance using GSENSOR (BTS Bioengineering), a medical device for motion analysis(approximately 6 weeks after starting the intervention)
  • Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007).(approximately 6 weeks after starting the intervention)
  • assessment of balance in response to perturbation applied by accelerating the dual-belt treadmill the dominant side at toe-off(approximately 6 weeks after starting the intervention)
  • evaluation of gait features using the GRAIL (Motekforce Link)(approximately 6 weeks after starting the intervention)

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (2)

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