Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Total score on the Suitability Evaluation Questionnaire (SEQ)
研究概览
简要总结
The main goal of this study is to investigate the tolerability to the use of the GRAIL system in subjects affected by Rett syndrome, particularly referred to:
- Grail environment (training in dark conditions, interaction with wide and surrounding screen, positioning over the treadmill);
- time to prepare a set of body marker in order to execute a gait analysis;
- walking activity over treadmill, with immersive virtual reality;
- proprioceptive stimulatione provided by the GRAIL platform;
- cognitive-attentive span time to the activity proposed. The secondary goal is to understand if a training that avail of treadmill and virtual reality would be useful in the future in improving gait characteristics in subjects affected by Rett syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subjects affected by Rett Syndrome that are able to walk with hands support (corresponding to a score ranging from 1 to 3 in item 8 of Rett Syndrome Gross Motor Scale)
排除标准
- •subjects unable to walk and with a complete incapacity to undestand verbal directions
结局指标
主要结局
Total score on the Suitability Evaluation Questionnaire (SEQ)
时间窗: immediately after the treatment
it is a subjective questionnaire assessing the suitability of the intervention. This is not a health outcome. Indeed SEQ is a questionnaire designed for virtual reality, composed by 13 questions, with a response graded on a 5-point Likert Scale, and a last open question. It measures measures enjoyment, sense of being in the system, feeling of success and control, realism, easy-to-understand instructions and general discomfort; furthermore it is aimed to detect issues frequently associated with virtual rehabilitation systems, like dizziness or nausea symptoms, eye discomfort, disorientation or confusion symptoms and sense of progress in rehabilitation. Finally, it evaluates the perceived difficulty of the task and the observed difficulty related with the physical interface used in the system.
次要结局
- Happiness index(immediately after the treatment)
- Gait analysis spatial parameters: temporal parameters in seconds and kinematics in degrees(immediately after the treatment)