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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
25
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Bretagne
-
Rennes、Bretagne、フランス、35000
- Pôle Saint-Hélier
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
number of the collisions with the environment on the standardised circuit
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
the time taken to complete the course
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：Immediately after intervention
|
It will be evaluated and compared by Igroup Presence Questionnaire IPQ.
|
Immediately after intervention
|
|
discomfort of driving in immersive reality,
時間枠：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
時間枠：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
時間枠：Immediately after intervention
|
Evaluation of acceptability with Unified Theory of Acceptance and Use of Technology (UTAUT) after each condition
|
Immediately after intervention
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年5月10日
一次修了 (実際)
2021年10月26日
研究の完了 (実際)
2021年10月26日
試験登録日
最初に提出
2021年5月3日
QC基準を満たした最初の提出物
2021年5月17日
最初の投稿 (実際)
2021年5月20日
学習記録の更新
投稿された最後の更新 (実際)
2021年11月1日
QC基準を満たした最後の更新が送信されました
2021年10月29日
最終確認日
2021年5月1日
詳しくは
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