Clinical trial NCT04171973: Evaluation of Electric Wheelchair Driving Performance in Simulator Compared to Driving in Real-life Situations
Official title: Evaluation of Electric Wheelchair Driving Performance in Simulator Compared to Driving in a Real-life Situation, in a Population of Regular Drivers With Neurological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurologic Disorder
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
Collaborators: name: INSA Rennes
First posted: 2019-11-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It is a pilot, prospective, monocentric, controlled, randomized, open-arms, open-ended, minimal risk and minimal constraint study (RIPH category 2).
Primary purpose: OTHER

Brief summary: The device that is the subject of this investigation is a solution for driving simulation of an electric wheelchair. It is intended to enable patients who are likely to acquire an electric wheelchair to train in a virtual environment, favorable to the safety of training, to its repetition, and to produce more varied, rich training environments and more tailored to specific and individualized needs. These solutions will make it easier to access real-world driving for patients who are currently experiencing learning difficulties.

It is expected that this investigation demonstrates the reproducibility of driving performance in electric wheelchair driving simulator compared to the real world.

Detailed description: As part of this investigation, it is expected to develop a driving simulator that could contribute to improving the learning of electric wheelchair driving and access to electric wheelchair for people who can not currently claim for physical risks and weak psychology for the participant in the research.

The present clinical investigation aims at evaluating the performances, the safety and the satisfaction of the users with regard to a simulator of driving of electric wheelchair in virtual reality.

The main objective is to evaluate the feasibility of a virtual electric wheelchair driving training, comparing driving performance in virtual reality versus reality, in identical real and virtual standardized circuits, in regular users of electric wheelchairs with neurological disorders.

Eligibility criteria: Inclusion Criteria:

* Male or female, over 18 years old,
* Having freely consented to participate in the study,
* With neurological degenerative disorders including cerebrovascular accident and head trauma or neurodegeneration including Parkinson's disease and related syndromes, multiple sclerosis, myopathy and amyotrophic lateral sclerosis,
* Having benefited from an electric wheelchair prescription and traveling in electric wheelchair for more than 3 months,
* Whose electric wheelchair is the main mode of travel,
* The physical measurements (weight, size) are compatible with the use of the physical simulator chosen for the development of the robotic assistance module, according to manufacturer's data 140 kg max and 51 cm max of seat width .

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 external, objectified by a negative answer to more than one item on the self-questionnaire WST QF for the items pertaining to driving (6 to 12 and 17 to 28):

  1. inability to perform certain driving tasks (answer "no")
  2. or insecure to achieve them (answer "not at all").
* pregnant, parturient or nursing mother,
* 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,
* Minor,
* Major under legal protection or unable to express his consent,
* Person in emergency situation who can not express their prior consent.

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 (WST)
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: Unified theory of acceptance of technology questionnaire (UTAUT)
timeFrame: Day 1, Day 8 and Day 15
measure: Igroup Presence Questionnaire (IPQ)
timeFrame: Day 1, Day 8 and Day 15
measure: The learning effect
timeFrame: Day 1, Day 8 and Day 15
measure: Graybiel score
timeFrame: Day 1, Day 8 and Day 15
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: