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Clinical Trials/NCT04072536
NCT04072536
Completed
Not Applicable

Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving of Patients With Neurological Disorders, Regular Drivers of Electric Wheelchairs.

Pôle Saint Hélier1 site in 1 country25 target enrollmentJune 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurological Disorders
Sponsor
Pôle Saint Hélier
Enrollment
25
Locations
1
Primary Endpoint
Number of collision
Status
Completed
Last Updated
6 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, 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.

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. Each patient included will test a wheelchair equipped with a collision avoidance assistance module in 2 conditions, assistance activated or not. This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance, in a random order established upstream.

Registry
clinicaltrials.gov
Start Date
June 3, 2019
End Date
June 18, 2019
Last Updated
6 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 freely consented to participate in the study,
  • suffering from neurological disorders such as cerebro-lesion or neuro-degeneration,
  • Having benefited from a prescription of electric wheelchair and circulating in an electric wheelchair for more than 3 months,
  • of which the electric wheelchair is the main mode of transport,
  • 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 having expressed difficulties impacting his safety of sedan and / or exterior.

Outcomes

Primary Outcomes

Number of collision

Time Frame: Day 15

The primary judgment criterion is the number of collisions on different standardized circuits with and without activation of the robotic assistance module.

Secondary Outcomes

  • Driving Speed(Day 1, Day 8 and Day 15)
  • Wheelchair Skill Test(Day 1, Day 8 and Day 15)
  • NASA-Task Load Index(Day 1, Day 8 and Day 15)
  • Ease of Use Questionnaire(Day 1, Day 8 and Day 15)
  • UTAUT (Unified theory of acceptance of technology) questionnaire(Day 1, Day 8 and Day 15)

Study Sites (1)

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