跳至主要内容
临床试验/NCT06866730
NCT06866730招募中不适用

Effect of Intensive Repetitive Motor Training in Toy Manipulation Supported by Gamified Physical Training Software in Children and Adolescents with Neurological Disorders Impacting Motor Skills

Fondation Ellen Poidatz4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年11月12日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
4
主要终点
Box and Blocks test

研究概览

简要总结

Cerebral palsy, and more broadly neurological disorders, can lead to significant motor impairments that impact individuals' daily lives. To address these limitations, the French National Authority for Health has issued recommendations for rehabilitative care, highlighting intensive training programs, physical activity, and interactive computer games. Scientific literature has also demonstrated the benefits of therapies that incorporate repetition.

In this study, the investigators aimed to train patients in producing grasp-and-release movements, and more broadly *reach-to-grasp* actions, in a manner intensified by movement repetition. To mitigate the boredom inherent to such repetitive tasks, the invesigators developed a device resembling a serious game, equipped with software, a modular physical platform, and two instrumented figurines designed to interact with the software.

Intensive therapy through repetitive movements, supported by the engaging nature of serious games, is expected to improve the manual skills of children with neurological disorders causing motor impairments.

To test this hypothesis, a cohort of 5 to 10 children aged 4 to 17 years with neurological disorders causing motor impairments will be invited to participate in the protocol. Participants will first undergo a baseline assessment, which will include repeated measurements of their score on the *Box and Blocks Test* and the active range of motion (AROM) of the wrist in extension and supination. An *Assisting Hand Assessment (AHA)* test will also be conducted.

Following this, a 4-week intervention will be implemented, consisting of three 40-minute sessions per week. During these sessions, the child will play the game and complete the *Box and Blocks Test* as well as active range of motion assessments.

In total, approximately 4 hours of gameplay is estimated over the course of the intervention, which will conclude with a repeat of the AHA test.

A follow-up assessment will take place two months after the intervention's end, with a single measurement of the three parameters (*Box and Blocks Test*, AROM, and AHA).

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

  • Neurological disorder causing motor impairment
  • Age 4 to 17 years old
  • MACS level I to III
  • Ability to cooperate, understand, and follow simple instructions to play the game.
  • Patient affiliated with the French social security system.
  • Voluntary patient whose parents have given consent for their child to participate in the study.

排除标准

  • A diagnosis of photosensitive epilepsy mentioned in the medical record AND/OR a note in the child's medical record or reported by the parents of a history of seizures triggered by video game use.
  • Botulinum toxin treatment within the 3 months prior to the study or intensive rehabilitation of manual skills (e.g., mCIMT, HABIT, etc.).
  • Sensory and/or cognitive impairments that would interfere with playing the game.

结局指标

主要结局

Box and Blocks test

时间窗: 3 months

Participant must transfer, one by one, with one hand, a maximum number of cubes from one side to the other of the box in 1 minute. A higher score represents better performance.

次要结局

  • Active Range of Motion(3 months)
  • Assisting Hand Assessment(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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