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临床试验/NCT05916677
NCT05916677已完成不适用

Virtual Reality-training in Theory of Mind in the Childhood Form of Myotonic Dystrophy Type 1

Institut de Myologie, France1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年10月30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
发起方
入组人数
35
试验地点
1
主要终点
NEPSY II

研究概览

简要总结

The ability of an individual to conceive some alternative representations and to behave in a flexible manner would emerge from preschool age and drastically improve between the ages of 3 and 5 (Doebel and Zelazo, 2013). They constitute, according to Diamond (2013), a prerequisite for the development of the Theory of Mind (ToM). Deficits in Executive Functions (EF) may therefore interfere with the child's ability to understand and adapt to social situations.

Treatment failures are often observed when traditional cognitive tools are used. This would be linked to the divergence between non-immersive tests and situations encountered in everyday life (Damasio, 1994; Priore Castelnuovo and Liccione, 2002). For this reason, an increasing number of researchers are using virtual reality for the rehabilitation of executive functions and Theory of Mind in patients with neurodevelopmental pathology (Millen, Edlin-White and Cobb, 2010) or brain damage (Le Gall, Besnard, Louisy, Richard and Allain 2008). There is currently no systematic evaluation of ToM in children with the infantile form of DM1 even though these abilities are considered particularly vulnerable and have a decisive impact on the subsequent development of interpersonal relationships.

This research will focus on studying the socio-emotional disorders associated with the infantile form of Myotonic Dystrophy type 1 (DM1). The axis that we propose to develop more specifically will be an interventional study with the aim of remediation with children from 5 to 16 years old suffering from the infantile form of DM1 via a training protocol in low-immersion Virtual Reality (VR) centered on emotional processing and theory of mind.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •6 years and < 16 years of age
  • •Written informed consent
  • •Affiliate or beneficiary of a social security scheme
  • •Able to comply with all protocol requirements
  • •Infantile form of DM1 with molecular confirmation.
  • •Development without incident in the first year
  • •Normal development in the pre and neonatal period
  • •Native language French

排除标准

  • •Unable to participate in the study
  • •Inability to comply with protocol requirements
  • •Congenital form of DM1
  • •IQ<70 (Intellectual Disability)

研究组 & 干预措施

Patient remediate using the virtual training method

Experimental

干预措施: Virtual Reality-training in Theory of Mind (Other)

Patient remediate using the traditional training method

Active Comparator

干预措施: Traditional training in Theory of Mind (Other)

结局指标

主要结局

NEPSY II

时间窗: Through study completion, an average of 5 weeks

Emotion Recognition and Standardized ToM

次要结局

  • WISC-V(Through study completion, on average 5 weeks)

研究者

发起方
Institut de Myologie, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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