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临床试验/CTRI/2024/03/063762
CTRI/2024/03/063762已完成不适用

Development of a Customized Non-Immersive Virtual Reality System as a Therapeutic Tool for Children with Cerebral Palsy

Dr Rama Krishna Challa2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年3月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Pediatric Balance Scale, Dyanamic balance, Intrinsic Motivation Inventory (IMI), Inertial Measurement Unit (IMU) Sensor data

研究概览

简要总结

This research study is a single-blinded, randomized, controlled trial conducted to compare the effects of conventional therapy and VR training on functional mobility and balance in children with cerebral palsy who are reported with walking and balancing difficulties. The study will involve 32 participants utilizing wearable sensors to interact with VR games during 45-minute sessions three times a week for up to 8 weeks. The primary outcome measures will be the Pediatric Balance Scale (PBS), Intrinsic Motivation Inventory (IMI), and sensor data. The secondary outcome will be the functional independence of children. The assessment scales will be performed on the first day and at the end of total therapy sessions. This research will help understand the children’s current balance and coordination abilities. Further, training the child using this device will enhance the children’s balance, coordination, and motivation. The results of this study will benefit children with cerebral palsy by improving ambulation, motivation to sustain activities, and functional balance.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

年龄范围
7.00 Year(s) 至 15.00 Year(s)(—)
性别
All

入选标准

  • 7 to 15 years of cerebral palsy (CP) kids, male or female, with spastic diplegia.
  • GMFC level 2 classification.
  • Able to understand verbal instructions and cooperate while playing the game.
  • Ability to stand and walk.
  • Kids whose parents and guardians sign the consent form.

排除标准

  • Participants who do not wish to play the virtual reality game.
  • Any orthopedic surgery in the last 3 – 6 months.
  • Treated with Botox in the last 3/6 months.
  • Any associated behavioral problems.

结局指标

主要结局

Pediatric Balance Scale, Dyanamic balance, Intrinsic Motivation Inventory (IMI), Inertial Measurement Unit (IMU) Sensor data

时间窗: 0 Week, End of 8th week

次要结局

  • Functional independence(0 Week, End of 8th week)

研究者

发起方
Dr Rama Krishna Challa
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Agrawal Luckykumar Dwarkadas

National Institute of Teachers Training and Research, Chandigarh

研究点 (2)

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