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临床试验/NCT02874911
NCT02874911已完成不适用

Coordination Training With Complete Body Video Games in Children and Adults With Degenerative Ataxias

University Hospital Tuebingen0 个研究点目标入组 10 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
主要终点
Gait

研究概览

简要总结

Exergame training might offer a novel treatment approach even in largely nonambulatory subjects with multisystemic degenerative spinocerebellar ataxia.

详细描述

Effective treatments for patients with degenerative spinocerebellar ataxia are scarce. It has recently been shown that intensive coordinative training based on either physiotherapy or exergames (= whole-body controlled videogames; might improve degenerative ataxia, but its effectiveness is still disputed. This situation is even more complicated for degenerative ataxia subjects in advanced disease stages and with high multisystemic disease load. Here, underlying neurodegeneration has progressed to many irreversible states and includes many additional extra-cerebellar systems, making functional plasticity and therapeutic success much less likely. Moreover, intervention outcome assessment in subjects unable to walk freely is more delicate. Correspondingly, nonambulatory ataxia subjects in advanced disease stages are currently often excluded from treatment trials, thus leaving them without prospects of access to novel treatments.

The investigators here hypothesized that exergame training might offer a novel treatment approach even in largely nonambulatory subjects with multisystemic degenerative spinocerebellar ataxia. Using a rater-blinded, intraindividual control study design, the investigators show that an individualized exergame training strategy, tailored to individuals' disease stage, improves postural control and ataxia-specific control functions even in advanced disease.

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
5 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Advanced spinocerebellar disease
  • •Advanced impairments in gait and stance, defined as Scale for Assessment and Rating of Ataxia (SARA) subscore gait ≥3 and stance ≥3, but still able to sit without support >10 seconds, as defined by SARA subscore sitting <3
  • •Age between 5 and 30 years

排除标准

  • •Any signs of inflammatory, vascular, malformation, or tumor cerebrospinal (CNS) disease
  • •Visual loss, hearing disturbances, mental retardation and predominant non-ataxia movement disorders (e.g. predominant spasticity, chorea, parkinsonism)

研究组 & 干预措施

General training

Experimental

Advanced spinocerebellar disease receive 12 weeks of coordinative training based on commercially available videogames (Product names: Nintendo Wii ®, Microsoft XBOX Kinect®).

干预措施: General training (Other)

结局指标

主要结局

Gait

时间窗: Week 13

Item 1 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

Stance

时间窗: Week 13

Item 2 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

Sitting

时间窗: Week 13

Item 3 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

Speech disturbance

时间窗: Week 13

Item 4 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

Finger chase

时间窗: Week 13

Item 5 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

Nose-finger Test

时间窗: Week 13

Item 6 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

Fast alternating hand movements

时间窗: Week 13

Item 7 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

Heel-shin slide

时间窗: Week 13

Item 8 of the Scale for the Assessment and Rating of Ataxia (SARA) score; total score made up of item 1 - 8

次要结局

  • Goal attainment Score(Week 13)
  • Quantitative movement analysis(Week 13)

研究者

申办方类型
Other
责任方
Sponsor

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