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Completed

NCT Number: NCT05292690

An Assistive Powered Wheelchair: Stage 2 Trial

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.

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Key information

Conditions

Multiple Sclerosis Amyotrophic Lateral Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniocerebral Trauma Cystic Fibrosis Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Digestive System Diseases Disease Attributes Genetic Diseases, Inborn Guillain-Barre Syndrome Immune System Diseases Infant, Newborn, Diseases Lung Diseases Metabolic Diseases Motor Neuron Disease Motor Neurone Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders Proteostasis Deficiencies Respiratory Tract Diseases Spinal Cord Diseases Stroke TDP-43 Proteinopathies Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

East Kent Hospitals NHS Foundation Trust

Canterbury, Kent, CT1 3NG, United Kingdom

About this study

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.

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Lacks capacity to consent

Treatment and study plan

Powered Wheelchair Obstacle Alerting System

Device

Evaluation of an Obstacle Alerting System

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: immediately after the intervention/procedure

    Range of movement scatter plots/ heat maps

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

    Time frame: 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

  5. Joystick path length with and without the Obstacle alerting System Active

    Time frame: 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

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

    Time frame: immediately after the intervention/procedure

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

Sponsors and collaborators

Lead sponsor

East Kent Hospitals University NHS Foundation Trust

Other Gov

Collaborators

  • KU Leuven
  • Sussex Community NHS Foundation Trust
  • University of Kent
  • l'Institut supérieur de l'électronique et du numérique (ISEN) Lille

Registry information

Official study title

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

Acronym: EDUCAT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2022
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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