跳至主要内容
临床试验/NCT05292690
NCT05292690已完成不适用

An Assistive Powered Wheelchair: Stage 2 Trial - Powered Wheelchair User Evaluation of an Obstacle Alerting System. A Non-interventional Study

East Kent Hospitals University NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Post-trial Participant Evaluation of the possible Value of the Obstacle Alerting System

研究概览

简要总结

Preliminary evaluation of an obstacle alerting system to enhance the user's independent mobility by improving their confidence to drive and their safety in driving a powered wheelchair.

详细描述

Many powered wheelchair users find that collision free driving presents a significant challenge to confident and safe driving. In some cases so much so that the user will not drive their chair in some environments.

Interviews with users in the EDUCAT project confirmed that users had problems driving safely and confidently in a confined space, passing through doorways or down narrow corridors and when reversing.

Therefore the goal of this stage of the project is to improve the quality of life of the powered chair user by developing an obstacle alerting system which will help improve their confidence and safety in driving.

This was to be achieved by asking expert users to provide feedback on the impact and usefulness of providing information about the presence and location of obstacles in the vicinity of their powered wheelchair.

There are two aspects to this.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults who are not wheelchair users.
  • Willing and able to provide a valid consent.
  • Able to participate in interviews aided or unaided using preferred method of communication.
  • Willing to drive a powered chair.

排除标准

  • Lacks capacity to consent

结局指标

主要结局

Post-trial Participant Evaluation of the possible Value of the Obstacle Alerting System

时间窗: immediately after the intervention/procedure

Post-trial questionnaire based on pre-trial questionnaire. Participants reassessed the Obstacle Alerting System \[OAS\] in the light of experience. In a face to face interview the participants were asked to score each question. 0=don't know, 1=not at all, to 5=very helpful. Participants were also asked to discuss the reasons for their choices. Asked when they found the OAS helpful and when unhelpful. Assessment of the feedback options and when they were and were not helpful. How could the OAS be improved to make it more user friendly and environment specific. Perceived benefit for Powered Chair Users.

Joystick path length with and without the Obstacle alerting System Active

时间窗: immediately after the intervention/procedure

Joystick path length - distance the participant moves the joystick to drive the course. Calculated from the joystick displacement X and Y coordinates. For a set course it would be expected that the path length will decrease as the participant learns to drive and familiarises with the course. Fatigue not having an impact. A lower score may occur with the Obstacle Alerting system active - if it helps. A higher score if it distracts. At present this is a novel measure of these factors

Time to complete the course with and without the Obstacle alerting System Active

时间窗: immediately after the intervention/procedure

Manually timed. Start when participant enters the course, stop when exiting the course

Pre-trial Participant Evaluation of the possible Value of an Obstacle Alerting System

时间窗: immediately before the intervention/procedure

The participant had been given an information sheet describing the Obstacle Alerting System. The participants were given the pre-trial questionnaire to obtain their opinion of the value of the Obstacle Alerting System. In a face to face interview the participants were asked to score each question. 0=don't know, 1=not at all, to 5=very helpful. Participants were also asked to discuss the reasons for their choices. Questions included. Value of warning of obstacles in the vicinity of the powered chair. Use of visual, auditory and haptic feedback in a range of environments e.g. small room, lifts, corridor, doorways, crowded spaces. The value of a reversing camera. Perceived benefit for Powered Chair Users.

Joystick range of movement patterns with and without the Obstacle alerting System Active

时间窗: immediately after the intervention/procedure

Range of movement scatter plots/ heat maps

Smoothness of joystick movement with and without the Obstacle alerting System Active

时间窗: immediately after the intervention/procedure

Smoothness of movement e.g. Normalised Jerk Score. A lower score indicates smoother and more controlled movements. Typical values for this trial are in the range of 3000-5000. A lower score is an indication of the participant learning to drive and becoming more familiar with the course. A lower score may occur with the Obstacle Alerting system active - if it helps. A higher score if it distracts. At present this is a novel measure of these factors

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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