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临床试验/NCT07158424
NCT07158424招募中不适用

Effects of Serious Games on Cognitive Function, Balance, and Quality of Life in Children With Cerebral Palsy: a Randomized Controlled Trial

Nataliya Hrabarchuk2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月11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
30
试验地点
2
主要终点
Score of the Trunk control measurement scale (TCMS)

研究概览

简要总结

Children with cerebral palsy (CP) often face challenges with balance, movement, and skills such as memory, problem-solving, and attention. These difficulties can affect not only daily activities but also their quality of life. Rehabilitation usually focuses on physical therapy, but recent research shows that combining movement training with cognitive tasks may be even more effective.

What we are studying. This study is focused at whether serious games from the Vana Vital platform-that was specifically designed for rehabilitation-can improve balance, cognition, and quality of life in children with CP. These games are not ordinary video games: they were created to encourage children to move, focus, and solve problems at the same time (dual-tasking).

The expected benefits include:

  • Better trunk control and stability.
  • Improved memory, attention, and reasoning.
  • Enhanced participation in daily life and overall well-being.

Takeaway. This study is exploring an innovative approach to rehabilitation: using technology and games not only to strengthen the body but also to train the mind. If successful, this method may provide a fun, effective, and family-friendly addition to traditional therapies for children with CP.

详细描述

Background. Cerebral palsy (CP) is one of the most common causes of movement difficulties in children. It is a lifelong condition that affects posture, coordination, and the ability to control movements. Many children with CP also experience challenges in other areas, such as attention, memory, and problem-solving. These challenges can make everyday tasks, school activities, and social participation more difficult.

Traditional rehabilitation programs focus on improving physical functions, especially motor control and balance. Training only movement may not be enough. Children may benefit from approaches that combine movement and cognitive training-practicing how to move while also thinking, remembering, or making quick decisions.

This idea is called dual-tasking: doing two things at the same time, such as walking while answering a question, or maintaining balance while remembering a sequence. In real life, dual-tasking is what we do constantly-walking while talking to a friend, keeping balance while carrying a schoolbag, or focusing in class while sitting upright. For children with CP, dual-tasking can be particularly difficult, but also particularly beneficial to practice.

Serious games are a new, innovative way to provide this training. Unlike ordinary video games, serious games are designed specifically for therapeutic purposes. They are meant to be engaging and motivating for children, while at the same time targeting key skills in motor and cognitive development.

What Makes This Study Unique. This study is among the first randomized controlled trials to test the Vana Vital platform-a suite of computer-based serious games that combine physical movements with cognitive tasks. Instead of repetitive exercises, children engage in playful adventures that require them to move their bodies while also solving challenges.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of cerebral palsy
  • Ability to attend the educational institutions
  • GMFCS I, II, III

排除标准

  • GMFCS IV, V
  • Uncooperative behaviour
  • Uncontrolled seizures

结局指标

主要结局

Score of the Trunk control measurement scale (TCMS)

时间窗: Baseline and 2 weeks

The TCMS is a standardized test used to evaluate trunk control in children with cerebral palsy. Trunk control is essential for posture, balance, and movement. A physiotherapist administers the test while the child sits without back or arm support and performs tasks that assess static sitting, selective trunk movements, and dynamic reaching. Each task is scored from 0 (unable) to 2 (able), with a maximum total of 58 points: 20 for static sitting, 28 for selective movement, and 10 for dynamic reaching. Higher scores indicate better trunk control and postural stability. Lower scores reflect greater difficulty with maintaining balance and controlling trunk movements. The test usually takes 15-20 minutes to complete and has been validated for children with CP. Changes in TCMS scores are considered clinically meaningful, as they reflect improvements in motor function, daily activities, and participation.

次要结局

  • Characteristics of the Static Balance Test(Baseline and 2 weeks)
  • Score of the cognitive tests from Sway Medical platform(Baseline and 2 weeks)
  • Score of the RAVEN's coloured progressive matrices (RCMP)(Baseline and 2 weeks)
  • Score of the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)(Baseline and 2 weeks)

研究者

发起方
Nataliya Hrabarchuk
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Nataliya Hrabarchuk

Dr.

Elita Rehabilitation Center

研究点 (2)

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