Clinical trial NCT04894981: Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders
Official title: Comparison of Power Wheelchair Driving Performance in a Physical Simulator With CAVE, Immersive Helmet and Non-immersive Screen in a Population of Drivers With Neurological Disorders: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurologic Disorder
Brain Injuries
Neurodegeneration
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
Collaborators: name: INSA Rennes
First posted: 2021-05-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a pilot, prospective, single-centre, controlled, randomised, crossover, open-label, study. (RIPH2)
Primary purpose: OTHER

Brief summary: This study aims to assess the impact of the choice of visual feedback solution (immersive via CAVE and VR headset; non-immersive via screen only) on driving performance and quality of experience on a physical driving simulator and its acceptability to wheelchair drivers with neurological disorders.

Detailed description: The device under investigation is an electric wheelchair driving simulation solution driving simulation solution for electric wheelchairs, based on a physical physical simulation device that integrates software allowing virtual virtual immersion. This device will be coupled with three visual simulation solutions: a virtual reality helmet, a CAVE (virtual reality room where video virtual reality room where video projectors display content on four sides) and a non-immersive projection (screen only, non-immersive virtual reality solution).

This device is intended to allow patients who may acquire a power wheelchair to train in a virtual environment, which is conducive to the safety of the training, its repetition, and to produce more varied training environments, richer and more adapted to specific and individualised needs. These solutions could facilitate access to real driving for patients who are currently experiencing learning difficulties.

Eligibility criteria: Inclusion Criteria:

* Male or female, over 18 years of age,
* Patient with neurological disorders such as brain injury or neurodegeneration,
* Having been prescribed an electric wheelchair and circulating in electric wheelchair for more than 3 months
* Of which electric wheelchair is the main mode of travel
* Whose physical measurements (weight, height) are compatible with the use of the physical simulator chosen for the development of the robotic assistance module, i.e. according to the manufacturer's data 140 kg max and 51 cm max seat width.
* Having freely consented to participate in the study,
* In the case of curatorship, having read the patient information document and given his/her free and informed consent to participate in the study, in the presence of his/her curator,
* In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and given his or her free and informed consent for the person for whom he or she is responsible to participate in the study (in agreement with the patient)

Exclusion Criteria:

* Comprehension problems that prevent the protocol from being carried out,
* Motor disorders of the upper limb requiring additional technical driving assistance,
* A patient who has expressed difficulties with internal and/or external driving safety on the basis of the WST,
* Patients who were included in the SIMADAPT1 study to avoid bias due to their experience in the simulator and virtual reality,
* Pregnant, parturient or breastfeeding women,
* Person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or for purposes other than research,
* Minor,
* Person in emergency situation unable to give prior consent.

Primary outcomes:
measure: number of the collisions with the environment on the standardised circuit
timeFrame: During the driving course, from the beginning to the end of the circuit.
Secondary outcomes:
measure: the time taken to complete the course
timeFrame: During the driving course, from the beginning to the end of the circuit.
measure: evaluation of driving performance with Wheelchair Skill Test (WST-Q-T 5.1)
timeFrame: Immediately after intervention
measure: visual information (VICON® system)
timeFrame: During the driving course, from the beginning to the end of the circuit.
measure: the cognitive load of carrying out the circuit with National Aeronautics and Space Administration Task Load Index
timeFrame: Immediately after intervention
measure: sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)
timeFrame: Immediately after intervention
measure: discomfort of driving in immersive reality,
timeFrame: Immediately after intervention
measure: satisfaction of the testers and the acceptability of the various conditions simulated
timeFrame: Immediately after intervention
measure: the acceptability of the various conditions simulated
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pole Saint-Hélier
state: Bretagne
Study officials:
affiliation: Pôle Saint Hélier
name: Philippe GALLIEN
role: PRINCIPAL_INVESTIGATOR
References: