Evaluation of Electric Wheelchair Driving Performance in Simulator Compared to Driving in a Real-life Situation, in a Population of Regular Drivers With Neurological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Number of collision
研究概览
简要总结
The device that is the subject of this investigation is a solution for driving simulation of an electric wheelchair. It is intended to enable patients who are likely to acquire an electric wheelchair to train in a virtual environment, favorable to the safety of training, to its repetition, and to produce more varied, rich training environments and more tailored to specific and individualized needs. These solutions will make it easier to access real-world driving for patients who are currently experiencing learning difficulties.
It is expected that this investigation demonstrates the reproducibility of driving performance in electric wheelchair driving simulator compared to the real world.
详细描述
As part of this investigation, it is expected to develop a driving simulator that could contribute to improving the learning of electric wheelchair driving and access to electric wheelchair for people who can not currently claim for physical risks and weak psychology for the participant in the research.
The present clinical investigation aims at evaluating the performances, the safety and the satisfaction of the users with regard to a simulator of driving of electric wheelchair in virtual reality.
The main objective is to evaluate the feasibility of a virtual electric wheelchair driving training, comparing driving performance in virtual reality versus reality, in identical real and virtual standardized circuits, in regular users of electric wheelchairs with neurological disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
盲法说明
Neither patients nor evaluators can be unaware of which group they are in.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, over 18 years old,
- •Having freely consented to participate in the study,
- •With neurological degenerative disorders including cerebrovascular accident and head trauma or neurodegeneration including Parkinson's disease and related syndromes, multiple sclerosis, myopathy and amyotrophic lateral sclerosis,
- •Having benefited from an electric wheelchair prescription and traveling in electric wheelchair for more than 3 months,
- •Whose electric wheelchair is the main mode of travel,
- •The physical measurements (weight, size) are compatible with the use of the physical simulator chosen for the development of the robotic assistance module, according to manufacturer's data 140 kg max and 51 cm max of seat width .
排除标准
- •Understanding difficulties preventing the realization of the protocol,
- •Motor disorders of the upper limb requiring additional driving technical assistance,
- •Patient having expressed difficulties impacting his safety of sedan and / or external, objectified by a negative answer to more than one item on the self-questionnaire WST QF for the items pertaining to driving (6 to 12 and 17 to 28):
- •inability to perform certain driving tasks (answer "no")
- •or insecure to achieve them (answer "not at all").
- •pregnant, parturient or nursing mother,
- •Person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or admitted to a health or social institution for purposes other than research,
- •Major under legal protection or unable to express his consent,
- •Person in emergency situation who can not express their prior consent.
结局指标
主要结局
Number of collision
时间窗: Day 15
The primary judgment criterion is the number of collisions on different standardized circuits in real condition versus virtual condition
次要结局
- Driving Speed(Day 1, Day 8 and Day 15)
- Unified theory of acceptance of technology questionnaire (UTAUT)(Day 1, Day 8 and Day 15)
- Igroup Presence Questionnaire (IPQ)(Day 1, Day 8 and Day 15)
- Ease of Use Questionnaire(Day 1, Day 8 and Day 15)
- The learning effect(Day 1, Day 8 and Day 15)
- Graybiel score(Day 1, Day 8 and Day 15)
- Wheelchair Skill Test (WST)(Day 1, Day 8 and Day 15)
- NASA-Task Load Index(Day 1, Day 8 and Day 15)