An Assistive Powered Wheelchair: Stage 2 Trial

NCT ID: NCT05292690

Last Updated: 2022-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-29

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis Stroke Cystic Fibrosis Motor Neurone Disease Craniocerebral Trauma Guillain-Barre Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Powered Wheelchair Obstacle Alerting System

Evaluation of an Obstacle Alerting System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Kent

OTHER

Sponsor Role collaborator

Sussex Community NHS Foundation Trust

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role collaborator

l'Institut supérieur de l'électronique et du numérique (ISEN) Lille

UNKNOWN

Sponsor Role collaborator

East Kent Hospitals University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed Sakel, MD

Role: PRINCIPAL_INVESTIGATOR

East Kent Hospitals University Foundation Trust

Locations

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East Kent Hospitals NHS Foundation Trust

Canterbury, Kent, United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol: Study Protocol

View Document

Document Type: Study Protocol and Informed Consent Form: Informed Consent for Photographic Images

View Document

Document Type: Informed Consent Form: Informed Consent to Participate in Trial

View Document

Other Identifiers

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2020/MEDPHYS/01

Identifier Type: -

Identifier Source: org_study_id

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