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Neurologic DisorderSIMADAPT1NCT04171973

Evaluation of Electric Wheelchair Driving Performance in Simulator Compared to Driving in Real-life Situations

A study testing Driving an electric wheelchair in real condition and Driving an electric wheelchair in virtual condition in people with Neurologic Disorder, run by Pôle Saint Hélier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The device that is the subject of this investigation is a solution for driving simulation of an electric wheelchair. It is intended to enable patients who are likely to acquire an electric wheelchair to train in a virtual environment, favorable to the safety of training, to its repetition, and to produce more varied… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neurologic Disorder
What is being tested?
Driving an electric wheelchair in real condition and Driving an electric wheelchair in virtual condition
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteFrance
Study dates
14 Jan 2020to 29 Jan 2020
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 old,
  • Having freely consented to participate in the study,
  • With neurological degenerative disorders including cerebrovascular accident and head trauma or neurodegeneration including Parkinson's disease and related syndromes, multiple sclerosis, myopathy and amyotrophic lateral sclerosis,
  • Having benefited from an electric wheelchair prescription and traveling in electric wheelchair for more than 3 months,
  • Whose electric wheelchair is the main mode of travel,
  • The physical measurements (weight, size) are compatible with the use of the physical simulator chosen for the development of the robotic assistance module, according to manufacturer's data 140 kg max and 51 cm max of seat width .

Who cannot join

  • Understanding difficulties preventing the realization of the protocol,
  • Motor disorders of the upper limb requiring additional driving technical assistance,
  • Patient having expressed difficulties impacting his safety of sedan and / or external, objectified by a negative answer to more than one item on the self-questionnaire WST QF for the items pertaining to driving (6 to 12 and 17 to 28):
  • inability to perform certain driving tasks (answer "no")
  • or insecure to achieve them (answer "not at all").
  • pregnant, parturient or nursing mother,
Show all 10Show fewer
  • Person deprived of liberty by a judicial or administrative decision, persons under psychiatric care or admitted to a health or social institution for purposes other than research,
  • Minor,
  • Major under legal protection or unable to express his consent,
  • Person in emergency situation who can not express their prior consent.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Pole Saint-Hélier

    Rennes, Brittany Region, 35000

Other trials in France

About this study

Official title: Evaluation of Electric Wheelchair Driving Performance in Simulator Compared to Driving in a Real-life Situation, in a Population of Regular Drivers With Neurological Disorders

The device that is the subject of this investigation is a solution for driving simulation of an electric wheelchair. It is intended to enable patients who are likely to acquire an electric wheelchair to train in a virtual environment, favorable to the safety of training, to its repetition, and to produce more varied, rich training environments and more tailored to specific and individualized needs. These solutions will make it easier to access real-world driving for patients who are currently experiencing learning difficulties.

It is expected that this investigation demonstrates the reproducibility of driving performance in electric wheelchair driving simulator compared to the real world.

Read the detailed description

As part of this investigation, it is expected to develop a driving simulator that could contribute to improving the learning of electric wheelchair driving and access to electric wheelchair for people who can not currently claim for physical risks and weak psychology for the participant in the research.

The present clinical investigation aims at evaluating the performances, the safety and the satisfaction of the users with regard to a simulator of driving of electric wheelchair in virtual reality.

The main objective is to evaluate the feasibility of a virtual electric wheelchair driving training, comparing driving performance in virtual reality versus reality, in identical real and virtual standardized circuits, in regular users of electric wheelchairs with neurological disorders.

Being tested
Driving an electric wheelchair in real condition, Driving an electric wheelchair in virtual condition
Medical subject headings
Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Driving an electric wheelchair in real conditionDevice

    For the control group, 3 test circuits of pipes in real condition of increasing difficulty are tested. Patients perform 2 passes in this condition.

  • Driving an electric wheelchair in virtual conditionDevice

    For the virtual reality group, the circuits have been digitized. Patients perform 2 passes in this condition.

Study groups in NCT04171973
Study groupRoleWhat they receive
Driving an electric wheelchair in real conditionOtherIn order to be able to evaluate the feasibility of virtual reality driving training, the driving performance will be evaluated on the same 3 standardized circuits: for the control group, 3 circuits of test of pipes in real condition of increasing difficulty are tested. Patients perform 2 passes in this condition.
Receives: Device: Driving an electric wheelchair in real condition
Driving an electric wheelchair in virtual conditionExperimentalIn order to be able to evaluate the feasibility of driving training in virtual reality, the driving performance will be evaluated on the same 3 standardized circuits: for the virtual reality group, the circuits have been digitized. Patients perform 2 passes in this condition.
Receives: Device: Driving an electric wheelchair in virtual condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of collision

    The primary judgment criterion is the number of collisions on different standardized circuits in real condition versus virtual condition

    Measured: Day 1

  2. Number of collision

    The primary judgment criterion is the number of collisions on different standardized circuits in real condition versus virtual condition

    Measured: Day 8

  3. Number of collision

    The primary judgment criterion is the number of collisions on different standardized circuits in real condition versus virtual condition

    Measured: Day 15

Secondary outcomes (8)

  1. Driving Speed

    Speed measured by the completion time of the course on the different circuits in real condition versus virtual condition

    Measured: Day 1, Day 8 and Day 15

  2. Wheelchair Skill Test (WST)

    Driving performance measured by the Wheelchair Skill Test items corresponding to the different courses in real condition versus virtual condition

    Measured: Day 1, Day 8 and Day 15

  3. NASA-Task Load Index

    The cognitive load of tests under both 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: Day 1, Day 8 and Day 15

  4. Ease of Use Questionnaire

    The satisfaction of the use of the electric wheelchair under the conditions will be evaluated by the self-questionnaire Ease of Use Questionnaire. It measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. The questionnaires were constructed as seven-point Likert rating scales. Users were asked to rate agreement with the statements, ranging from strongly disagree (1) to strongly agree (7).

    Measured: Day 1, Day 8 and Day 15

  5. Unified theory of acceptance of technology questionnaire (UTAUT)

    Questionnaire of acceptability / acceptance of the tool and its use by patients based on the Unified Theory of Acceptance and Use Technology (UTAUT).

    Measured: Day 1, Day 8 and Day 15

  6. Igroup Presence Questionnaire (IPQ)

    The IPQ comprises 14 items rated on a seven-point Likert Scale ranging from -3 to 3. The general item assesses the general "sense of being there", and has high loadings on all three factors, with an especially strong loading on Spatial Presence. The Spatial Presence sub-scale is related to the sense of being physically inside the virtual environment. The involvement sub-scale is directed to evaluate the attention devoted to the virtual environment. The realness sub-scale evaluates the sense of reality attributed to the virtual environment.

    Measured: Day 1, Day 8 and Day 15

  7. The learning effect

    The learning effect on the virtual circuit and on the real circuit, will be evaluated by progression / stabilization of the time of realization during the sequence of repetitions.

    Measured: Day 1, Day 8 and Day 15

  8. Graybiel score

    Assessment of discomfort and motion sickness to quantify the intensity of different symptoms during motion sickness.

    Measured: Day 1, Day 8 and Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2019
  2. Study start14 Jan 2020
  3. Primary completion29 Jan 2020
  4. Study completion29 Jan 2020

Resources

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
It is a pilot, prospective, monocentric, controlled, randomized, open-arms, open-ended, minimal risk and minimal constraint study (RIPH category 2).
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04171973
Sponsor's protocol ID
2019-A01903-54
Acronym
SIMADAPT1
Status last verified
Nov 2019
First submitted
19 Nov 2019
Last updated
31 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fraudet B, Leblong E, Piette P, Nicolas B, Gouranton V, Babel M, Devigne L, Pasteau F, Gallien P. Evaluation of power wheelchair driving performance in simulator compared to driving in real-life situations: the SIMADAPT (simulator ADAPT) project-a pilot study. J Neuroeng Rehabil. 2024 Apr 23;21(1):60. doi: 10.1186/s12984-024-01354-5.

    PubMed 38654367

Questions about this trial

What is this clinical trial studying?

A study testing Driving an electric wheelchair in real condition and Driving an electric wheelchair in virtual condition in people with Neurologic Disorder, 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 6 inclusion and 10 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 31 Jan 2020. 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 collision (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04171973, which also lists 1 linked publication.

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 31 Jan 2020.

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