Clinical trial NCT04259151: Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving
Official title: Evaluation on Standardized Circuits of the Interest of a Robotic Module of Assistance to the Driving of Patients With Neurological Disorders, in Difficulty Driving of Electric Wheelchairs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Disorder
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
Collaborators: name: INSA Rennes
First posted: 2020-02-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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.

This study "SWADAPT2" follows "SWADAPT1" with patients with Neurological Disorders, Regular Drivers of Electric Wheelchairs, in the same conditions :

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.

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 or learning to drive.
* Having difficulties driving an electric wheelchair impacting their indoor and/or outdoor driving safety, as shown by the WST score.
* 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.

Primary outcomes:
measure: Number of collision
timeFrame: Day 1
measure: Number of collision
timeFrame: Day 8
measure: Number of collision
timeFrame: Day 15
Secondary outcomes:
measure: Driving Speed
timeFrame: Day 1, Day 8 and Day 15
measure: Wheelchair Skill Test
timeFrame: Day 1, Day 8 and Day 15
measure: NASA-Task Load Index
timeFrame: Day 1, Day 8 and Day 15
measure: Ease of Use Questionnaire
timeFrame: Day 1, Day 8 and Day 15
measure: UTAUT (Unified theory of acceptance of technology) questionnaire
timeFrame: Day 1, Day 8 and Day 15
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pôle Saint-Hélier
state: Bretagne
Study officials:
affiliation: Pôle Saint Hélier
name: Philippe Gallien, Doctor
role: PRINCIPAL_INVESTIGATOR
References: