Developing Immersive Gamification Technology System for Rehabilitation Management of Pediatric Patients With Cerebral Palsy and Mobility Limitations (Phase 2 Trial)
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
- Walking speed will be assessed using 10MWT
研究概览
简要总结
The proposed research project aims to answer the question "Are immersive technology systems effective in the rehabilitation management of pediatric patients with cerebral palsy and with mobility limitations?". The current study is the second of three phases, and it aims to create an immersive gamification technology system for the management of patients with cerebral palsy and with mobility disorders and to determine its clinical effectiveness, safety, and usability among children with mild to moderate cerebral palsy.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 6-12 years old
- •Able to walk without a mobility device with limited speed, balance, and/or coordination (equivalent to Gross Motor Function Classification System - Expanded and Revised (GMFCS) Level I or II)
- •Can handle objects easily and successfully (equivalent to Manual Ability Classification System, MACS, Level I)
- •Able to follow one-step instructions during BOTMP
排除标准
- •Children with CP functioning at GMFCS Level III or higher
- •Children who are totally dependent (i.e., those who require 100% assistance or support from another adult to complete tasks or for transfers or ambulation)
- •Have had episodes of seizures or previously diagnosed as having epilepsy or are taking antiepileptic or seizure medications
- •Have significant visual impairment
- •Have hearing impairment requiring hearing aid
- •Have a history of motion sickness
- •Experience claustrophobia
结局指标
主要结局
Walking speed will be assessed using 10MWT
时间窗: Within one hour after completion of the sixth session
The 10-meter walk test (10MWT) assesses the walking speed of a child over a short distance
Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire
时间窗: Immediately after each intervention, within an hour of completion of the virtual reality game
The VRSQ will measure a participant's experience with the following symptoms: general discomfort, fatigue, eye strain, difficulty focusing, headache, fullness of head, blurring of vision, dizziness (when eyes are closed), and vertigo. Symptoms will be rated on a 4-point scale: 0 or None, 1 or Slight, 2 or Moderate, and 3 or Severe.
Balance will be assessed using Pediatric Balance Scale
时间窗: Within one hour after completion of the sixth session
The Pediatric Balance Scale is used to assess skills in functional balance among school-aged children. It rates a child's ability and records the time it takes for a child to maintain balance in different scenarios. Items are rated from 0 to 4, with a minimum score of 0 and a maximum score of 56. Changes are noted to be significant if the Pediatric Balance Scale score improvements are at least 0.79 points for the Pediatric Balance Scale-static scale, 0.96 points for the Pediatric Balance Scale-dynamic scale, and 1.59 points on the Pediatric Balance Scale-total scale.
Gross motor performance will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency (Second Edition; Short Form)
时间窗: Within one hour after completion of the sixth session
The Bruininks-Oseretsky Test of Motor Proficiency (Second Edition) is a comprehensive test of a child's fine and gross motor skills
Functional ability will be assessed using Bruininks-Oseretsky Test of Motor Proficiency (Second Edition, Short Form)
时间窗: Within one hour after completion of the sixth session
The Bruininks-Oseretsky Test of Motor Proficiency (Second Edition, Short Form) is a comprehensive test of a child's fine and gross motor skills
Balance will be assessed using the Timed Up and Go in Children
时间窗: Within one hour after completion of the sixth session
Timed-Up and Go in Children is a timed test of functional dynamic balance where a child is tasked to stand up from a sitting position, walk 3 meters, turn and walk back, and sit down.
Functional ability will be assessed using Timed-Up and Go in Children
时间窗: Within one hour after completion of the sixth session
Timed-Up and Go in Children is a timed test of functional dynamic balance where a child is tasked to stand up from a sitting position, walk 3 meters, turn and walk back, and sit down.
Usability of the virtual reality intervention will be assessed using a researcher usability checklist
时间窗: Immediately after each intervention, within an hour of completion of the virtual reality game
Usability will also be measured by the application's performance. Effectiveness will be measured in terms of task completion within a given time period, while efficiency will be measured in terms of ease of use of the controllers and the interface. Satisfaction will be determined through observation of participant reactions.
Usability of the virtual reality intervention will be assessed using the System Usability Scale
时间窗: Immediately after each intervention, within an hour of completion of the virtual reality game
The SUS is a 10-item questionnaire that is widely used in the evaluation of various kinds and aspects of technology. Each question has five response options ranging from 'Strongly agree' to 'Strongly disagree', which has a corresponding number value. Each response is added and multiplied by 2.5 to obtain the final score that ranges from 0 to 100. A SUS score above 68 is considered above average.
次要结局
未报告次要终点