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

NCT04894981 | Completed

• 1 other identifier: 2021-A00120-41
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Disorder; Brain Injuries; Neurodegeneration

Outcome Measures

Primary Outcomes (1)

• number of the collisions with the environment on the standardised circuit

  It will be compared in 4 conditions : * immersive 1: physical simulator and CAVE\_condition A1 * immersive 2: physical simulator and virtual reality helmet\_condition A2 * non-immersive 1: screen and physical simulator\_condition B1 * non-immersive 2: screen only without simulator\_condition B2 Day 1 : A + B Day 8 : A + B

  During the driving course, from the beginning to the end of the circuit.

Secondary Outcomes (8)

• the time taken to complete the course

  During the driving course, from the beginning to the end of the circuit.

• evaluation of driving performance with Wheelchair Skill Test (WST-Q-T 5.1)

  Immediately after intervention

• visual information (VICON® system)

  During the driving course, from the beginning to the end of the circuit.

• the cognitive load of carrying out the circuit with National Aeronautics and Space Administration Task Load Index

  Immediately after intervention

• sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)

  Immediately after intervention

Study Arms (2)

Immersive condition

EXPERIMENTAL

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

Device: Immersive condition (CAVE); Device: Immersive condition (HMD)

Non Immersive condition

EXPERIMENTAL

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

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

Interventions

Immersive condition (CAVE) DEVICE

Driving course with obstacles in a CAVE system

Immersive condition

Immersive condition (HMD) DEVICE

Driving course with obstacles with a virtual reality headset

Immersive condition

Non Immersive condition (Screen alone) DEVICE

Driving course with obstacles on a screen with physical simulator

Non Immersive condition

Non Immersive condition (Screen with physical simulator) DEVICE

Driving course with obstacles on a screen only

Non Immersive condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pôle Saint Hélier: lead
• INSA Rennes: collaborator

Study Sites (1)

Pole Saint-Hélier

Rennes, Brittany Region, 35000, France

Location

MeSH Terms

Conditions

Nervous System Diseases; Brain Injuries; Nerve Degeneration

Interventions

Early Detection of Cancer

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Early Diagnosis; Diagnosis

Study Officials

• Philippe GALLIEN

  Pôle Saint Hélier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot, prospective, single-centre, controlled, randomised, crossover, open-label, study. (RIPH2)

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 20, 2021
• Study Start: May 10, 2021
• Primary Completion: October 26, 2021
• Study Completion: October 26, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-05

Locations

FR (1)