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临床试验/NCT04353115
NCT04353115已完成不适用

Usability of a Serious Game to Rehabilitate Gaze Stability in Children with Vestibular Deficit: "Kids Gaze Rehabilitation"

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2021年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Numbers of patients able to use the serious game without side effects

研究概览

简要总结

Since the early 2000s, vestibular rehabilitation has been proposed as a therapeutic tool to improve the balancing function and the various motor skills in children, in particular in children with hearing loss suffering from concomitant vestibular deficit. It has been demonstrated in adults with vestibular deficit that the fact of adding to the classic exercises on the control of balance per se and habituation, specific exercises of adaptation and substitution of the vestibulo-ocular reflex brought therapeutic benefit. These exercises, which are started in the presence of the physiotherapist and then continued by the patient himself at his home, aim to improve the stabilization of the gaze during head movements. In pediatrics, however, performing them is more difficult than conventional exercises, since their immediate interest is not well understood by the child, who may be reluctant to perform them. The present project aims to enrich the therapeutic offer by a pediatric rehabilitation method of eye stabilization sufficiently playful to win adherence to treatment, including in the absence of the physiotherapist when the child is at home.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
4 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with a vestibular disorder by the batteries of tests used in clinical routine.
  • Supported by the multidisciplinary team of the Audiology and Otoneurological Exploration Department at the HFME
  • Patient or parents able to understand the ins and outs of the study
  • No opposition from children and parents

排除标准

  • Associated visual sensorineural deficit
  • Orthopedic or muscular disorder in the cervical spine

结局指标

主要结局

Numbers of patients able to use the serious game without side effects

时间窗: Week 5

the purpose is to defined the proportion of patients able to use the serious game without side effects for 20 minutes a day, 2 days a week for 5 weeks in the presence of a doctor or physiotherapist at the hospital in addition to the usual rehabilitation.

次要结局

  • Patient satisfaction(week 5)
  • Satisfaction of the patient's parents(Week 5)
  • Alouette test(Week 5)
  • side effects after the 5 weeks of intervention(Week 5)
  • Posturo-motor control(Week 5)
  • Visual acuity(Week 5)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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