Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving 1 (SWADAPT1)
신경장애 환자, 일반 전동휠체어 운전자의 운전보조 로봇모듈 관심 표준화 회로에 대한 평가.
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Brittany Region
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Rennes, Brittany Region, 프랑스, 35000
- Pôle Saint-Hélier
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
다른: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of collision
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Driving Speed
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Philippe Gallien, Doctor, Pôle Saint Hélier
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2019-A00476-51
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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