Clinical trial NCT05459779: Evaluation of a Robotic Assistance Module Against Positive and Negative Obstacles for Driving Electric Wheelchair
Official title: 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.
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: 2022-07-15
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.
Primary purpose: PREVENTION

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.

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,
* Minors,
* a person in an emergency situation, unable to express his prior consent.

Primary outcomes:
measure: Success rate
timeFrame: Day 1
Secondary outcomes:
measure: NASA-Task Load Index
timeFrame: Day 1
measure: Calculated task load Index
timeFrame: Day 1
measure: Spontaneous stress assessment
timeFrame: Day 1
measure: Calculated Stress Index
timeFrame: Day 1
measure: Ease of Use Questionnaire
timeFrame: Day 1
measure: UTAUT (Unified theory of acceptance of technology) questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pole Saint-Hélier
state: Bretagne
Study officials:
affiliation: Pôle Saint Hélier
name: Philippe Gallien, Doctor
role: PRINCIPAL_INVESTIGATOR
References: