Back to resultsComparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders (SIMADAPT2)
Primary Purpose
Neurologic Disorder, Brain Injuries, Neurodegeneration
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Immersive condition (CAVE)
Immersive condition (HMD)
Non Immersive condition (Screen alone)
Non Immersive condition (Screen with physical simulator)
Sponsored by
About this trial
This is an interventional other trial for Neurologic Disorder
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.
Sites / Locations
- Pole Saint-Hélier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immersive condition
Non Immersive condition
Arm Description
Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD)
Performance driving wheelchair in non immersive condition (with screen and physical simulator or screen only)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
the time taken to complete the course
It will be measured, in minutes and seconds, under the various conditions
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
visual information (VICON® system)
The number of head movement will be measured by VICON system.
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)
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.
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.
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.
the acceptability of the various conditions simulated
Evaluation of acceptability with Unified Theory of Acceptance and Use of Technology (UTAUT) after each condition
Full Information
NCT ID
NCT04894981
First Posted
May 3, 2021
Last Updated
October 29, 2021
Sponsor
Pôle Saint Hélier
Collaborators
INSA Rennes
1. Study Identification
Unique Protocol Identification Number
NCT04894981
Brief Title
Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders
Acronym
SIMADAPT2
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
October 26, 2021 (Actual)
Study Completion Date
October 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pôle Saint Hélier
Collaborators
INSA Rennes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Disorder, Brain Injuries, Neurodegeneration
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a pilot, prospective, single-centre, controlled, randomised, crossover, open-label, study. (RIPH2)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immersive condition
Arm Type
Experimental
Arm Description
Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD)
Arm Title
Non Immersive condition
Arm Type
Experimental
Arm Description
Performance driving wheelchair in non immersive condition (with screen and physical simulator or screen only)
Intervention Type
Device
Intervention Name(s)
Immersive condition (CAVE)
Intervention Description
Driving course with obstacles in a CAVE system
Intervention Type
Device
Intervention Name(s)
Immersive condition (HMD)
Intervention Description
Driving course with obstacles with a virtual reality headset
Intervention Type
Device
Intervention Name(s)
Non Immersive condition (Screen alone)
Intervention Description
Driving course with obstacles on a screen with physical simulator
Intervention Type
Device
Intervention Name(s)
Non Immersive condition (Screen with physical simulator)
Intervention Description
Driving course with obstacles on a screen only
Primary Outcome Measure Information:
Title
number of the collisions with the environment on the standardised circuit
Description
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
Time Frame
During the driving course, from the beginning to the end of the circuit.
Secondary Outcome Measure Information:
Title
the time taken to complete the course
Description
It will be measured, in minutes and seconds, under the various conditions
Time Frame
During the driving course, from the beginning to the end of the circuit.
Title
evaluation of driving performance with Wheelchair Skill Test (WST-Q-T 5.1)
Description
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
Time Frame
Immediately after intervention
Title
visual information (VICON® system)
Description
The number of head movement will be measured by VICON system.
Time Frame
During the driving course, from the beginning to the end of the circuit.
Title
the cognitive load of carrying out the circuit with National Aeronautics and Space Administration Task Load Index
Description
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)
Time Frame
Immediately after intervention
Title
sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)
Description
It will be evaluated and compared by Igroup Presence Questionnaire IPQ.
Time Frame
Immediately after intervention
Title
discomfort of driving in immersive reality,
Description
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.
Time Frame
Immediately after intervention
Title
satisfaction of the testers and the acceptability of the various conditions simulated
Description
Patients will be asked to rate their satisfaction on a scale of 0 to 10, with 10 being very satisfied.
Time Frame
Immediately after intervention
Title
the acceptability of the various conditions simulated
Description
Evaluation of acceptability with Unified Theory of Acceptance and Use of Technology (UTAUT) after each condition
Time Frame
Immediately after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe GALLIEN
Organizational Affiliation
Pôle Saint Hélier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pole Saint-Hélier
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders
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