跳至主要内容
临床试验/NCT05378828
NCT05378828终止不适用

Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors to Improve the Driving Confidence of Elderly People in EHPAD

Pôle Saint Hélier6 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
6
主要终点
Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD

研究概览

简要总结

The device which is the subject of this investigation is a robotic assistance module for the driving of a semi-autonomous electric wheelchair (FRE). It's intended to accessorize the FRE to improve the safety conditions during the driving of a FRE, making it possible to decrease the rate of accident in wheelchair on the one hand, increase the confidence of driving on the other hand, and facilitate the access to the FRE of people not being able to aspire to it without the use of a device of safety of this type.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Over 60 years of age,
  • Resident in an institution for the elderly or nursing home,
  • with a electric wheelchair but expressing driving difficulties
  • Having freely consented to participate in the study,
  • 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 having 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

  • Impaired comprehension preventing the protocol from being carried out,
  • Person in an emergency situation unable to give prior consent

结局指标

主要结局

Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD

时间窗: Day 42

Evaluation by using the under score of confidence of Wheelchair Skill Test questionnaire (WST-Q-T 5.1) during the period of use of the module and at the end. The score goes from 0 to 56 (56 is the higher level of confidence).

次要结局

  • Distance traveled measured by sensors on the FRE(Day 21, Day 42 and Day 63)
  • Driving habilities(Day 42 and Day 63)
  • Acceptability of anti-collision sensors by users(Day 42)
  • Mesure of mental load related to wheelchair mobility(Day 21, Day 42 and Day 63)
  • Ease of Use Questionnaire(Day 42)

研究者

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

研究点 (6)

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