Multiple SclerosisEDUCATNCT05292690
An Assistive Powered Wheelchair: Stage 2 Trial
An observational study of Multiple Sclerosis and Stroke, run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Stroke, Cystic Fibrosis
- What is being tested?
- Powered Wheelchair Obstacle Alerting System
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Mar 2021to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult non-powered wheelchair users
Who may be able to join
- 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.
Who cannot join
- 1. Lacks capacity to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Kent Hospitals NHS Foundation Trust
Canterbury, Kent, CT1 3NG
About this study
Official title: 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.
Read the 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.
- 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.
- Conditions
- Multiple Sclerosis, Stroke, Cystic Fibrosis, Motor Neurone Disease, Craniocerebral Trauma, Guillain-Barre Syndrome
- Being tested
- Powered Wheelchair Obstacle Alerting System
- Medical subject headings
- Multiple Sclerosis, Stroke, Cystic Fibrosis, Amyotrophic Lateral Sclerosis, Craniocerebral Trauma, Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered Wheelchair Obstacle Alerting SystemDevice
Evaluation of an Obstacle Alerting System
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: immediately after the intervention/procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start29 Mar 2021
- Primary completion1 Apr 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Kent Hospitals University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Kent, Sussex Community NHS Foundation Trust, KU Leuven, l'Institut supérieur de l'électronique et du numérique (ISEN) Lille
- Responsible party
- Sponsor
- Investigators
- Mohamed Sakel, MD, Principal investigator, East Kent Hospitals University Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292690
- Sponsor's protocol ID
- 2020/MEDPHYS/01
- Acronym
- EDUCAT
- Status last verified
- Jul 2022
- First submitted
- 2 Feb 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assistive Powered Wheelchair: Stage 2 Trial - Powered Wheelchair User Evaluation of an Obstacle Alerting System. A Non-interventional Study
- ClinicalTrials.gov ID
- NCT05292690
- Acronym / sponsor ID
- EDUCAT / 2020/MEDPHYS/01
- Conditions
- Multiple Sclerosis, Stroke, Cystic Fibrosis, Motor Neurone Disease, Craniocerebral Trauma, Guillain-Barre Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- East Kent Hospitals University NHS Foundation TrustOther government
- Collaborators
- University of Kent, Sussex Community NHS Foundation Trust, KU Leuven, l'Institut supérieur de l'électronique et du numérique (ISEN) Lille
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult non-powered wheelchair users
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Lacks capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powered Wheelchair Obstacle Alerting SystemEvaluation of an Obstacle Alerting System | Device | – |
Primary outcome
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.
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.
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Sakel, MD principal investigator
East Kent Hospitals University Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Stroke, run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-trial Participant Evaluation of the possible Value of an Obstacle Alerting System (time frame: immediately before the intervention/procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.