Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders (SIMADAPT2)
2021年10月29日 更新者：Pôle Saint Hélier
Comparison of Power Wheelchair Driving Performance in a Physical Simulator With CAVE, Immersive Helmet and Non-immersive Screen in a Population of Drivers With Neurological Disorders: Pilot Study
This study aims to assess the impact of the choice of visual feedback solution (immersive via CAVE and VR headset; non-immersive via screen only) on driving performance and quality of experience on a physical driving simulator and its acceptability to wheelchair drivers with neurological disorders.
研究概览
地位
完全的
详细说明
The device under investigation is an electric wheelchair driving simulation solution driving simulation solution for electric wheelchairs, based on a physical physical simulation device that integrates software allowing virtual virtual immersion. This device will be coupled with three visual simulation solutions: a virtual reality helmet, a CAVE (virtual reality room where video virtual reality room where video projectors display content on four sides) and a non-immersive projection (screen only, non-immersive virtual reality solution).
This device is intended to allow patients who may acquire a power wheelchair to train in a virtual environment, which is conducive to the safety of the training, its repetition, and to produce more varied training environments, richer and more adapted to specific and individualised needs. These solutions could facilitate access to real driving for patients who are currently experiencing learning difficulties.
研究类型
介入性
注册 (实际的)
25
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Bretagne
-
Rennes、Bretagne、法国、35000
- Pôle Saint-Hélier
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male or female, over 18 years of age,
- Patient with neurological disorders such as brain injury or neurodegeneration,
- Having been prescribed an electric wheelchair and circulating in electric wheelchair for more than 3 months
- Of which electric wheelchair is the main mode of travel
- Whose physical measurements (weight, height) are compatible with the use of the physical simulator chosen for the development of the robotic assistance module, i.e. according to the manufacturer's data 140 kg max and 51 cm max seat width.
- Having freely consented to participate in the study,
- In the case of curatorship, having read the patient information document and given his/her free and informed consent to participate in the study, in the presence of his/her curator,
- In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and given his or her free and informed consent for the person for whom he or she is responsible to participate in the study (in agreement with the patient)
Exclusion Criteria:
- Comprehension problems that prevent the protocol from being carried out,
- Motor disorders of the upper limb requiring additional technical driving assistance,
- A patient who has expressed difficulties with internal and/or external driving safety on the basis of the WST,
- Patients who were included in the SIMADAPT1 study to avoid bias due to their experience in the simulator and virtual reality,
- Pregnant, parturient or breastfeeding women,
- Person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or for purposes other than research,
- Minor,
- Person in emergency situation unable to give prior consent.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Immersive condition
Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD)
|
Driving course with obstacles in a CAVE system
Driving course with obstacles with a virtual reality headset
|
|
实验性的：Non Immersive condition
Performance driving wheelchair in non immersive condition (with screen and physical simulator or screen only)
|
Driving course with obstacles on a screen with physical simulator
Driving course with obstacles on a screen only
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
number of the collisions with the environment on the standardised circuit
大体时间：During the driving course, from the beginning to the end of the circuit.
|
It will be compared in 4 conditions :
|
During the driving course, from the beginning to the end of the circuit.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the time taken to complete the course
大体时间：During the driving course, from the beginning to the end of the circuit.
|
It will be measured, in minutes and seconds, under the various conditions
|
During the driving course, from the beginning to the end of the circuit.
|
|
evaluation of driving performance with Wheelchair Skill Test (WST-Q-T 5.1)
大体时间：Immediately after intervention
|
The Wheelchair Skill Test (WST-Q-T 5.1) will be completed by two evaluators after each condition. The score will be between 0 to 22, a high score will represent a good driving performance |
Immediately after intervention
|
|
visual information (VICON® system)
大体时间：During the driving course, from the beginning to the end of the circuit.
|
The number of head movement will be measured by VICON system.
|
During the driving course, from the beginning to the end of the circuit.
|
|
the cognitive load of carrying out the circuit with National Aeronautics and Space Administration Task Load Index
大体时间：Immediately after intervention
|
The cognitive load of tests under each conditions will be measured by the NASA-Task Load Index.
It is in the form of six scales where the participant must assign a score between zero and one hundred to each of them, score indicating a growing level of intensity.
Three dimensions relate to the demands imposed on the subject (mental, physical and temporal demands) and three to the interaction of a subject with the task (effort, frustration and performance)
|
Immediately after intervention
|
|
sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)
大体时间：Immediately after intervention
|
It will be evaluated and compared by Igroup Presence Questionnaire IPQ.
|
Immediately after intervention
|
|
discomfort of driving in immersive reality,
大体时间：Immediately after intervention
|
The occurrence of kinetosis will be evaluated with Graybiel score by the two evaluators after each passage in each condition. The score is between 1 to 50. A high score shows the patient's discomfort. |
Immediately after intervention
|
|
satisfaction of the testers and the acceptability of the various conditions simulated
大体时间：Immediately after intervention
|
Patients will be asked to rate their satisfaction on a scale of 0 to 10, with 10 being very satisfied.
|
Immediately after intervention
|
|
the acceptability of the various conditions simulated
大体时间：Immediately after intervention
|
Evaluation of acceptability with Unified Theory of Acceptance and Use of Technology (UTAUT) after each condition
|
Immediately after intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年5月10日
初级完成 (实际的)
2021年10月26日
研究完成 (实际的)
2021年10月26日
研究注册日期
首次提交
2021年5月3日
首先提交符合 QC 标准的
2021年5月17日
首次发布 (实际的)
2021年5月20日
研究记录更新
最后更新发布 (实际的)
2021年11月1日
上次提交的符合 QC 标准的更新
2021年10月29日
最后验证
2021年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.