Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving 1 (SWADAPT1)
電動車椅子の定期的な運転者である神経障害患者の運転を支援するロボットモジュールの関心のある標準化された回路の評価。
The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.
調査の概要
状態
条件
詳細な説明
The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type.
Each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Brittany Region
-
Rennes、Brittany Region、フランス、35000
- Pôle Saint-Hélier
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged over 18,
- Having freely consented to participate in the study,
- suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
- Having benefited from a prescription of electric wheelchair and circulating in an electric wheelchair for more than 3 months,
- of which the electric wheelchair is the main mode of transport,
- The physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module.
Exclusion Criteria:
- 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 exterior.
研究計画
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Electric wheelchair with activated assistance module
This condition will be achieved in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream. |
This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance |
|
他の：Electric wheelchair with assistance module not activated
This condition will be achieved in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 without activated assistance, in a random order established upstream. |
This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with no activated assistance |
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 collision
時間枠：Day 1
|
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module. |
Day 1
|
|
Number of collision
時間枠：Day 8
|
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module. |
Day 8
|
|
Number of collision
時間枠：Day 15
|
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module. |
Day 15
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Driving Speed
時間枠：Day 1, Day 8 and Day 15
|
Speed measured by the completion time of the course with and without activation of the assistance system on the different circuits |
Day 1, Day 8 and Day 15
|
|
Wheelchair Skill Test
時間枠：Day 1, Day 8 and Day 15
|
Driving performance measured by the Wheelchair Skill Test items corresponding to the different courses, with and without activation of the assistance system |
Day 1, Day 8 and Day 15
|
|
NASA-Task Load Index
時間枠：Day 1, Day 8 and Day 15
|
The cognitive load of tests under both 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) |
Day 1, Day 8 and Day 15
|
|
Ease of Use Questionnaire
時間枠：Day 1, Day 8 and Day 15
|
The satisfaction of the use of the electric wheelchair under the conditions will be evaluated by the self-questionnaire Ease of Use Questionnaire. It measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. The questionnaires were constructed as seven-point Likert rating scales. Users were asked to rate agreement with the statements, ranging from strongly disagree (1) to strongly agree (7). |
Day 1, Day 8 and Day 15
|
|
UTAUT (Unified theory of acceptance of technology) questionnaire
時間枠：Day 1, Day 8 and Day 15
|
Questionnaire of acceptability / acceptance of the tool and its use by patients based on the Unified Theory of Acceptance and Use Technology (UTAUT). |
Day 1, Day 8 and Day 15
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Philippe Gallien, Doctor、Pôle Saint Hélier
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2019-A00476-51
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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