Neurologic DisorderSIMADAPT2NCT04894981
Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders
A study testing Immersive condition (CAVE), Immersive condition (HMD) and Non Immersive condition (Screen alone) in people with Neurologic Disorder and Brain Injuries, run by Pôle Saint Hélier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorder, Brain Injuries, Neurodegeneration
- What is being tested?
- Immersive condition (CAVE), Immersive condition (HMD) and Non Immersive condition (Screen alone)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2021to 26 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Neurologic Disorder, Brain Injuries, Neurodegeneration
- Being tested
- Immersive condition (CAVE), Immersive condition (HMD), Non Immersive condition (Screen alone), Non Immersive condition (Screen with physical simulator)
- Medical subject headings
- Nervous System Diseases, Brain Injuries, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive condition (CAVE)Device
Driving course with obstacles in a CAVE system
Immersive condition (HMD)Device
Driving course with obstacles with a virtual reality headset
Non Immersive condition (Screen alone)Device
Driving course with obstacles on a screen with physical simulator
Non Immersive condition (Screen with physical simulator)Device
Driving course with obstacles on a screen only
| Study group | Role | What they receive |
|---|---|---|
| Immersive condition | Experimental | Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD) Receives: 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) Receives: Device: Non Immersive condition (Screen alone); Device: Non Immersive condition (Screen with physical simulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the driving course, from the beginning to the end of the circuit.
Secondary outcomes (8)
the time taken to complete the course
It will be measured, in minutes and seconds, under the various conditions
Measured: 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
Measured: Immediately after intervention
visual information (VICON® system)
The number of head movement will be measured by VICON system.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start10 May 2021
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a pilot, prospective, single-centre, controlled, randomised, crossover, open-label, study. (RIPH2)
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pôle Saint Hélier
- Sponsor type
- University, hospital or other
- Collaborators
- INSA Rennes
- Responsible party
- Sponsor
- Investigators
- Philippe GALLIEN, Principal investigator, Pôle Saint Hélier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894981
- Sponsor's protocol ID
- 2021-A00120-41
- Acronym
- SIMADAPT2
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04894981
- Acronym / sponsor ID
- SIMADAPT2 / 2021-A00120-41
- Conditions
- Neurologic Disorder, Brain Injuries, Neurodegeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Pôle Saint HélierUniversity, hospital or other
- Collaborators
- INSA Rennes
- Study start
- 10 May 2021 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot, prospective, single-centre, controlled, randomised, crossover, open-label, study. (RIPH2)
| Arm | Type | Receives |
|---|---|---|
| Immersive condition | Experimental | Device: Immersive condition (CAVE), Device: Immersive condition (HMD)Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD) |
| Non Immersive condition | Experimental | Device: Non Immersive condition (Screen alone), Device: Non Immersive condition (Screen with physical simulator)Performance driving wheelchair in non immersive condition (with screen and physical simulator or screen only) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive condition (CAVE)Driving course with obstacles in a CAVE system | Device | Immersive condition |
| Immersive condition (HMD)Driving course with obstacles with a virtual reality headset | Device | Immersive condition |
| Non Immersive condition (Screen alone)Driving course with obstacles on a screen with physical simulator | Device | Non Immersive condition |
| Non Immersive condition (Screen with physical simulator)Driving course with obstacles on a screen only | Device | Non Immersive condition |
Primary outcome
number of the collisions with the environment on the standardised circuit
Time frame: During the driving course, from the beginning to the end of the 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
8 secondary outcomes
the time taken to complete the course
Time frame: 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)
Time frame: Immediately after intervention
visual information (VICON® system)
Time frame: 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
Time frame: Immediately after intervention
sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)
Time frame: Immediately after intervention
discomfort of driving in immersive reality,
Time frame: Immediately after intervention
satisfaction of the testers and the acceptability of the various conditions simulated
Time frame: Immediately after intervention
the acceptability of the various conditions simulated
Time frame: Immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Related trials for Neurologic Disorder
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe GALLIEN principal investigator
Pôle Saint Hélier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive condition (CAVE), Immersive condition (HMD) and Non Immersive condition (Screen alone) in people with Neurologic Disorder and Brain Injuries, run by Pôle Saint Hélier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of the collisions with the environment on the standardised circuit (time frame: During the driving course, from the beginning to the end of the circuit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.