Developing Immersive Gamification Technology System (ImGTS) for Rehabilitation Management of Pediatric Patients With Cerebral Palsy and With Mobility Limitations (Phase 1 Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 1
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 first 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 acceptability, usability, and safety in healthy children.
详细描述
The participants will undergo an intervention using the assigned ImGTS for four sessions (twice a week for two weeks) for at most 1 hour per session. The experience will last for at most 20 minutes, interspersed with 5- to 20-minute breaks. The researchers will document the participants' reaction and interaction with the ImGTS. Participants will be staying at the designated laboratory for not more than one hour.
Demographic characteristics of the participant (age, sex, educational level, primary caregiver, list of medications, hobbies and interests, previous experience with VR applications, existing illnesses and medications) will be collected through an interview with the child and the participant's parent, legal guardian, or caregiver.
Safety will be determined by assessing a participant's experience of cybersickness using a cybersickness questionnaire that will be administered before and after each session. In this self-report questionnaire, nine symptoms will be rated as absent/none, slight, moderate, or severe. These symptoms are general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness when the eyes are closed, and vertigo. The questionnaire will take around 10 minutes to complete. If a participant will experience severe cybersickness, the participant may opt to discontinue the experience. The participant will be instructed to remove the HMD or to step out of the Semi-CAVE room to rest and recover from the symptoms. A medical professional will be present to monitor the participant's symptoms and to attend to the participant for further management. The reason(s) for discontinuing the experience will be documented.
The acceptability of the design will be measured using the Place Probe, a sense of place questionnaire. The questionnaire will be administered after each session, and it will collect information on a participant's experience in the VR application, particularly on (1) general impression of the environment, (2) the key features of the environment, and (3) feelings of presence. A positive general impression, a memorable environment, and a high level of presence will indicate that the VE developed is acceptable. This will take about 10 minutes to complete.
Usability testing will be performed according to the PNS ISO/IEC Metrics. The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction. Additional usability metrics will be identified during the first phase of the study. The metrics will be specifically adjusted to the target participants as well as the contents to be included in the ImGTS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 6 to 12 years old
- •Demonstrates fine and gross motor abilities within the norm for the child's age as measured by the Bruininks-Oseretsky Test of Motor Proficiency Test (BOTMP)
排除标准
- •Previously diagnosed with any developmental disorder including CP
- •Has had episodes of seizures or previously diagnosed as having epilepsy
- •Has a history of motion sickness
- •Unable to follow one-step instructions
结局指标
主要结局
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 1
时间窗: Immediately before Session 1, within an hour of before use of the virtual reality game
Baseline assessment for the presence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
The acceptability of the design for Session 1 will be measured using the Place Probe
时间窗: Immediately after Session 1, within an hour of completion of the virtual reality game
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
The acceptability of the design for Session 3 will be measured using the Place Probe
时间窗: Immediately after Session 3, within an hour of completion of the virtual reality game
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 4
时间窗: Immediately after Session 4, within an hour of completion of the virtual reality game
Assessment for the occurrence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Observation of ease of use of controls and user interaction during Session 4 to measure efficiency of the application during Session 4
时间窗: For one hour during Session 4
Efficiency is a component of usability that will assess a participant's ease of use of the controls and user interface during the experience. If at least 85% of the participants do not encounter or express difficulties in using the application during the experience, the game is said to be efficient.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 1
时间窗: Immediately after Session 1, within an hour of completion of the virtual reality game
Assessment for the occurrence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 2
时间窗: Immediately after Session 2, within an hour of completion of the virtual reality game
Assessment for the occurrence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 3
时间窗: Immediately before Session 3, within an hour of before use of the virtual reality game
Baseline assessment for the presence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
The acceptability of the design for Session 2 will be measured using the Place Probe
时间窗: Immediately after Session 2, within an hour of completion of the virtual reality game
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 3
时间窗: Immediately after Session 3, within an hour of completion of the virtual reality game
Assessment for the occurrence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
The acceptability of the design for Session 4 will be measured using the Place Probe
时间窗: Immediately after Session 4, within an hour of completion of the virtual reality game
The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 2
时间窗: Immediately before Session 2, within an hour of before use of the virtual reality game
Baseline assessment for the presence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 4
时间窗: Immediately before Session 4, within an hour of before use of the virtual reality game
Baseline assessment for the presence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.
Observation of completion of the game in the given time during Session 4 to measure effectiveness of the application
时间窗: For one hour during Session 4
Effectiveness is a component of usability, and will be assessed through observing completion of the game within the allotted time. If at least 85% of the participants complete the game within the allotted time, the game is said to be effective.
Observation of user reactions to measure satisfaction in using the application through during Session 4
时间窗: For one hour during Session 4
Satisfaction is a component of usability that will assess a participant's enjoyment in using the game. It will be assessed through observing the reaction of the participant during Session 4. If 90% of the participants visibly show or verbally express enjoyment during the experience, the game is said to be satisfactory.
次要结局
未报告次要终点