Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving of Patients With Neurological Disorders, Regular Drivers of Electric Wheelchairs.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of collision
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
To minimize bias, this study will be randomized and conducted in single blind. The patient will not be aware of the activation or not of the assistance module placed on the electric wheelchair. Indeed, the investigative team will be in charge of the activation of the robotic module.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Electric wheelchair with activated assistance module (Device)
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.
干预措施: Electric wheelchair with assistance module not activated (Device)
结局指标
主要结局
Number of collision
时间窗: Day 15
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.
Number of collision
时间窗: Day 1
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.
Number of collision
时间窗: Day 8
The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.
次要结局
- Wheelchair Skill Test(Day 1, Day 8 and Day 15)
- NASA-Task Load Index(Day 1, Day 8 and Day 15)
- Driving Speed(Day 1, Day 8 and Day 15)
- Ease of Use Questionnaire(Day 1, Day 8 and Day 15)
- UTAUT (Unified theory of acceptance of technology) questionnaire(Day 1, Day 8 and Day 15)