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Clinical Trials/NCT05459779
NCT05459779
Completed
Not Applicable

Evaluation of a Robotic Assistance Module for Driving Electric Wheelchairs Allowing the Avoidance of Positive and Negative Obstacles on the Driving Safety of Patients With Neurological Disorders.

Pôle Saint Hélier1 site in 1 country18 target enrollmentJuly 8, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurological Disorder
Sponsor
Pôle Saint Hélier
Enrollment
18
Locations
1
Primary Endpoint
Success rate
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, which on the one hand reduces the accident rate of wheelchair and on the other hand and facilitates the access to the wheelchair to people who cannot claim it without the use of a safety device of this type. The robotic assistance module is programmed to detect positive and negative obstacles.

Detailed Description

The device that is the subject of this investigation is a robotic assistance module for driving a semi-autonomous electric wheelchair. This module is designed to accessorize the electric wheelchair to improve the safety conditions when driving an electric wheelchair, thus reducing the wheelchair accident rate on the one hand and facilitating access to the wheelchair to persons who can not claim it without the use of a safety device of this type. The robotic assistance module is program to detect positive and negative obstacles. This study "SWADAPT3" follows "SWADAPT1" and "SWADAPT2" with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions: Each patient included tested a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation was carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient performed the circuit 6 times, including 3 with activated assistance, in a random order established upstream.

Registry
clinicaltrials.gov
Start Date
July 8, 2022
End Date
July 12, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Pôle Saint Hélier
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged over 18,
  • Having read the information note and freely consented to participate in the study,
  • Suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
  • Having benefited from an electric wheelchair prescription and/or learning to drive,
  • The physical measurements (weight, height) are compatible with the use of the electric wheelchair chosen for the development of the robotics assistance module.

Exclusion Criteria

  • Understanding difficulties preventing the realization of the protocol,
  • Motor disorders of the upper limb requiring additional driving technical assistance,
  • Patient who has expressed difficulties impacting their internal and/or external driving safety,
  • Pregnant, parturient or breastfeeding women,
  • A person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or admitted to a health or social institution for purposes other than research,
  • a person in an emergency situation, unable to express his prior consent.

Outcomes

Primary Outcomes

Success rate

Time Frame: Day 1

Pass rate across standard platforms. The platform has been divided into sectors. The crossing of the platform stops as soon as a failure occurs (swing or collision). The circuit is composed of 9 platforms divided into 91 sectors. At the end, the success rate corresponds to the numbers of sector past with success with and without activation of the assistance system. Score rate : 0-91

Secondary Outcomes

  • Ease of Use Questionnaire(Day 1)
  • Spontaneous stress assessment(Day 1)
  • Calculated task load Index(Day 1)
  • NASA-Task Load Index(Day 1)
  • UTAUT (Unified theory of acceptance of technology) questionnaire(Day 1)
  • Calculated Stress Index(Day 1)

Study Sites (1)

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