An Assistive Powered Wheelchair: Stage 2 Trial

NCT05292690 | Completed

• 1 other identifier: 2020/MEDPHYS/01
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Powered Wheelchair Obstacle Alerting System DEVICE

Evaluation of an Obstacle Alerting System

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult non-powered wheelchair users

You may qualify if:

• 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.

You may not qualify if:

• \. Lacks capacity to consent

Sponsors & Collaborators

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

Study Sites (1)

East Kent Hospitals NHS Foundation Trust

Canterbury, Kent, CT1 3NG, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis; Stroke; Cystic Fibrosis; Amyotrophic Lateral Sclerosis; Craniocerebral Trauma; Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohamed Sakel, MD

  East Kent Hospitals University Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 23, 2022
• Study Start: March 29, 2021
• Primary Completion: April 1, 2021
• Study Completion: August 31, 2021
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

GB (1)