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

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Injuries; Neurologic Disorder; Neurodegeneration
• Intervention / Treatment: Device: Immersive condition (CAVE); Device: Immersive condition (HMD); Device: Non Immersive condition (Screen alone); Device: Non Immersive condition (Screen with physical simulator)

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bretagne
    • Rennes, Bretagne, France, 35000
      • Pôle Saint-Hélier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immersive condition; Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD)	Device: Immersive condition (CAVE); Driving course with obstacles in a CAVE system; Device: Immersive condition (HMD); Driving course with obstacles with a virtual reality headset
Experimental: Non Immersive condition; Performance driving wheelchair in non immersive condition (with screen and physical simulator or screen only)	Device: Non Immersive condition (Screen alone); Driving course with obstacles on a screen with physical simulator; Device: Non Immersive condition (Screen with physical simulator); Driving course with obstacles on a screen only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time taken to complete the course	It will be measured, in minutes and seconds, under the various conditions	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)	The Wheelchair Skill Test (WST-Q-T 5.1) will be completed by two evaluators after each condition. The score will be between 0 to 22, a high score will represent a good driving performance	Immediately after intervention
visual information (VICON® system)	The number of head movement will be measured by 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	The cognitive load of tests under each conditions will be measured by the NASA-Task Load Index. It is in the form of six scales where the participant must assign a score between zero and one hundred to each of them, score indicating a growing level of intensity. Three dimensions relate to the demands imposed on the subject (mental, physical and temporal demands) and three to the interaction of a subject with the task (effort, frustration and performance)	Immediately after intervention
sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)	It will be evaluated and compared by Igroup Presence Questionnaire IPQ.	Immediately after intervention
discomfort of driving in immersive reality,	The occurrence of kinetosis will be evaluated with Graybiel score by the two evaluators after each passage in each condition. The score is between 1 to 50. A high score shows the patient's discomfort.	Immediately after intervention
satisfaction of the testers and the acceptability of the various conditions simulated	Patients will be asked to rate their satisfaction on a scale of 0 to 10, with 10 being very satisfied.	Immediately after intervention
the acceptability of the various conditions simulated	Evaluation of acceptability with Unified Theory of Acceptance and Use of Technology (UTAUT) after each condition	Immediately after intervention

Collaborators and Investigators

• Sponsor: Pôle Saint Hélier
• Collaborators: INSA Rennes
• Investigators: Principal Investigator: Philippe GALLIEN, Pole Saint Helier

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): October 26, 2021
• Study Completion (Actual): October 26, 2021

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Nervous System Diseases; Nerve Degeneration
• Other Study ID Numbers: 2021-A00120-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No