Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders (SIMADAPT2)
2021년 10월 29일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
25
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bretagne
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Rennes, Bretagne, 프랑스, 35000
- Pôle Saint-Hélier
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Immersive condition
Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD)
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Driving course with obstacles in a CAVE system
Driving course with obstacles with a virtual reality headset
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실험적: Non Immersive condition
Performance driving wheelchair in non immersive condition (with screen and physical simulator or screen only)
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Driving course with obstacles on a screen with physical simulator
Driving course with obstacles on a screen only
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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number of the collisions with the environment on the standardised circuit
기간: During the driving course, from the beginning to the end of the circuit.
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It will be compared in 4 conditions :
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During the driving course, from the beginning to the end of the circuit.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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the time taken to complete the course
기간: During the driving course, from the beginning to the end of the circuit.
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It will be measured, in minutes and seconds, under the various conditions
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During the driving course, from the beginning to the end of the circuit.
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evaluation of driving performance with Wheelchair Skill Test (WST-Q-T 5.1)
기간: Immediately after intervention
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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
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visual information (VICON® system)
기간: During the driving course, from the beginning to the end of the circuit.
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The number of head movement will be measured by VICON system.
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During the driving course, from the beginning to the end of the circuit.
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the cognitive load of carrying out the circuit with National Aeronautics and Space Administration Task Load Index
기간: Immediately after intervention
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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)
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Immediately after intervention
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sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)
기간: Immediately after intervention
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It will be evaluated and compared by Igroup Presence Questionnaire IPQ.
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Immediately after intervention
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discomfort of driving in immersive reality,
기간: Immediately after intervention
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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
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satisfaction of the testers and the acceptability of the various conditions simulated
기간: Immediately after intervention
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Patients will be asked to rate their satisfaction on a scale of 0 to 10, with 10 being very satisfied.
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Immediately after intervention
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the acceptability of the various conditions simulated
기간: Immediately after intervention
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Evaluation of acceptability with Unified Theory of Acceptance and Use of Technology (UTAUT) after each condition
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Immediately after intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 5월 10일
기본 완료 (실제)
2021년 10월 26일
연구 완료 (실제)
2021년 10월 26일
연구 등록 날짜
최초 제출
2021년 5월 3일
QC 기준을 충족하는 최초 제출
2021년 5월 17일
처음 게시됨 (실제)
2021년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 11월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 10월 29일
마지막으로 확인됨
2021년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .