An Assistive Powered Wheelchair: Stage 2 Trial (EDUCAT)

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Multiple Sclerosis; Craniocerebral Trauma; Cystic Fibrosis; Guillain-Barre Syndrome; Motor Neurone Disease
• Intervention / Treatment: Device: Powered Wheelchair Obstacle Alerting System

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.

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Canterbury, Kent, United Kingdom, CT1 3NG
      • East Kent Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult non-powered wheelchair users

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-trial Participant Evaluation of the possible Value of an Obstacle Alerting System	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.	immediately before the intervention/procedure
Post-trial Participant Evaluation of the possible Value of the Obstacle Alerting System	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.	immediately after the intervention/procedure
Joystick range of movement patterns with and without the Obstacle alerting System Active	Range of movement scatter plots/ heat maps	immediately after the intervention/procedure
Smoothness of joystick movement with and without the Obstacle alerting System Active	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	immediately after the intervention/procedure
Joystick path length with and without the Obstacle alerting System Active	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	immediately after the intervention/procedure
Time to complete the course with and without the Obstacle alerting System Active	Manually timed. Start when participant enters the course, stop when exiting the course	immediately after the intervention/procedure

Collaborators and Investigators

• Sponsor: East Kent Hospitals University NHS Foundation Trust
• Collaborators: KU Leuven; University of Kent; Sussex Community NHS Foundation Trust; l'Institut supérieur de l'électronique et du numérique (ISEN) Lille
• Investigators: Principal Investigator: Mohamed Sakel, MD, East Kent Hospitals University Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Pancreatic Diseases; Polyradiculoneuropathy; Polyneuropathies; Multiple Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Cystic Fibrosis; Craniocerebral Trauma; Guillain-Barre Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 2020/MEDPHYS/01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No