跳至主要内容
临床试验/NCT06449495
NCT06449495招募中不适用

Treatment of Balance and Coordination Disorders in the Pediatric Population With the Virtual Reality System Nirvana.

IRCCS Eugenio Medea5 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
5
主要终点
Stabilometry with force platforms

研究概览

简要总结

Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living in pediatric population. There are several systems that can be used to treat balance and coordination disorders and those that use virtual reality, such as NIRVANA, are becoming increasingly popular. The primary objective of this post-market clinical investigation is to evaluate the efficacy of the semi-immersive virtual reality platform NIRVANA (BTS Bioengineering), in accordance with the protocol defined at IRCCS Medea in Bosisio Parini, in children with balance and coordination disorders on both motor function and cognitive processes that are indirectly stimulated.

详细描述

Balance and coordination disorders limit the achievement of autonomy in movement and activities of daily living.

Among the various conditions commonly associated with balance and gait deficits in the pediatric population, neurological diseases represent an important subgroup, as do neurodevelopmental disorders. Children with balance and coordination problems typically have difficulty walking independently and manifest a gait characterized by an enlarged base of support and are generally prone to frequent falls.

Coordination deficits also result in a reduction in the fluidity of functional gestures with a consequent negative impact on quality of life.

Not only that, in the presence of the above-mentioned problems, psycho-motor retardation is also often evident in children, consequently presenting cognitive, relational and learning problems as well.

There are several systems that can be used to treat balance and coordination disorders; in particular, those that use virtual reality systems such as NIRVANA are becoming increasingly popular. This device has been used in subjects with neurological disorders (Stroke, Parkinson's, and Multiple Sclerosis) with good results in both motor and visuocognitive areas. To date there are still few studies of this device in the pediatric setting, although its effectiveness in both autism spectrum disorders and global developmental delays is beginning to be explored.

研究设计

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

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • balance or coordination disorders of different etiology: tumor, post-traumatic, neurodegenerative, syndromic, congenital, or associated with neurodevelopmental delay. - - - age between 4 and 17 years
  • independent ambulation
  • ability to understand simple verbal instructions.

排除标准

  • wheelchair-bound
  • major cognitive and behavioural problems.

结局指标

主要结局

Stabilometry with force platforms

时间窗: T0(pre-training),T1 (after 4 weeks of training)

Evaluation of static balance

Gross Motor Function Measure-88 (GMFM-88)

时间窗: T0(pre-training),T1 (after 4 weeks of training)

Evaluation of the motricity

Pediatric Berg Balance Scale (PBBS)

时间窗: T0(pre-training),T1 (after 4 weeks of training)

Functional balance

次要结局

  • Continuous Performance Test (CPT or KCPT)(T0(pre-training),T1 (after 4 weeks of training))

研究者

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

研究点 (5)

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