Clinical trial NCT05292690: An Assistive Powered Wheelchair: Stage 2 Trial
Official title: An Assistive Powered Wheelchair: Stage 2 Trial - Powered Wheelchair User Evaluation of an Obstacle Alerting System. A Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Stroke
Cystic Fibrosis
Motor Neurone Disease
Craniocerebral Trauma
Guillain-Barre Syndrome
Lead sponsor: East Kent Hospitals University NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Kent
name: Sussex Community NHS Foundation Trust
name: KU Leuven
name: l'Institut supérieur de l'électronique et du numérique (ISEN) Lille
First posted: 2022-03-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult non-powered wheelchair users

Brief summary: 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.

Detailed description: 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.

1. User assessment of the usefulness of the obstacle alerting feedback. This will include user evaluation of the value of the different modes of feedback - audio, visual and haptic - and how best to adapt these to the range of driving environments and driving speeds. And what level of control the user requires to select and deselect these options.
2. Monitoring the user's driving patterns with and without obstacle alerting -using the Stage 1 recording device.

The analysis of this data, and feedback from the Users and carers will inform the development and design of the obstacle alerting system.

Because of the COVID-19 pandemic the trial could not be carried out with powered wheel-chair users participating as they represented a clinically vulnerable part of the population. The trial was, therefore, adapted and carried out with adult non-wheelchair users.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Lacks capacity to consent

Primary outcomes:
measure: Pre-trial Participant Evaluation of the possible Value of an Obstacle Alerting System
timeFrame: immediately before the intervention/procedure
measure: Post-trial Participant Evaluation of the possible Value of the Obstacle Alerting System
timeFrame: immediately after the intervention/procedure
measure: Joystick range of movement patterns with and without the Obstacle alerting System Active
timeFrame: immediately after the intervention/procedure
measure: Smoothness of joystick movement with and without the Obstacle alerting System Active
timeFrame: immediately after the intervention/procedure
measure: Joystick path length with and without the Obstacle alerting System Active
timeFrame: immediately after the intervention/procedure
measure: Time to complete the course with and without the Obstacle alerting System Active
timeFrame: immediately after the intervention/procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Canterbury
country: United Kingdom
facility: East Kent Hospitals NHS Foundation Trust
state: Kent
Study officials:
affiliation: East Kent Hospitals University Foundation Trust
name: Mohamed Sakel, MD
role: PRINCIPAL_INVESTIGATOR
References: