Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders (SIMADAPT2)

Pôle Saint Hélier

Status: Completed

Conditions: Brain Injuries; Neurodegeneration; Neurologic Disorder

Treatments: Device: Non Immersive condition (Screen with physical simulator); Device: Immersive condition (CAVE); Device: Non Immersive condition (Screen alone); Device: Immersive condition (HMD)

Study type: Interventional

Funder types: Other

Identifiers

NCT04894981

2021-A00120-41

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Immersive condition

Experimental group

Description:

Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD)

Treatment:

Device: Immersive condition (HMD)

Device: Immersive condition (CAVE)

Non Immersive condition

Experimental group

Description:

Performance driving wheelchair in non immersive condition (with screen and physical simulator or screen only)

Treatment:

Device: Non Immersive condition (Screen with physical simulator)

Device: Non Immersive condition (Screen alone)