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临床试验/NCT04894981
NCT04894981已完成不适用

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

Pôle Saint Hélier2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
number of the collisions with the environment on the standardised circuit

研究概览

简要总结

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.

详细描述

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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,
  • Person in emergency situation unable to give prior consent.

结局指标

主要结局

number of the collisions with the environment on the standardised circuit

时间窗: During the driving course, from the beginning to the end of the circuit.

It will be compared in 4 conditions : * immersive 1: physical simulator and CAVE_condition A1 * immersive 2: physical simulator and virtual reality helmet_condition A2 * non-immersive 1: screen and physical simulator_condition B1 * non-immersive 2: screen only without simulator_condition B2 Day 1 : A + B Day 8 : A + B

次要结局

  • the time taken to complete the course(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)(Immediately after intervention)
  • visual information (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(Immediately after intervention)
  • sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)(Immediately after intervention)
  • discomfort of driving in immersive reality,(Immediately after intervention)
  • satisfaction of the testers and the acceptability of the various conditions simulated(Immediately after intervention)
  • the acceptability of the various conditions simulated(Immediately after intervention)

研究者

发起方
Pôle Saint Hélier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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