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

NCT ID: NCT04171973

Last Updated: 2020-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2020-01-29

Brief 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, 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.

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.

Conditions

Neurologic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Driving an electric wheelchair in real condition

In 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.

Group Type: OTHER

Driving an electric wheelchair in real condition

Intervention Type: DEVICE

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 condition

In 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.

Group Type: EXPERIMENTAL

Driving an electric wheelchair in virtual condition

Intervention Type: DEVICE

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

Interventions

Driving an electric wheelchair in real condition

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

Intervention Type: DEVICE

Driving an electric wheelchair in virtual condition

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 .

Exclusion Criteria

• 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):

1. inability to perform certain driving tasks (answer "no")

2. or insecure to achieve them (answer "not at all").

• pregnant, parturient or nursing mother,
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

INSA Rennes

OTHER

Sponsor Role: collaborator

Pôle Saint Hélier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe Gallien, Doctor

Role: PRINCIPAL_INVESTIGATOR

Pôle Saint Hélier

Locations

Pole Saint-Hélier

Rennes, Brittany Region, France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 38654367 (View on PubMed)

Other Identifiers

2019-A01903-54

Identifier Type: -

Identifier Source: org_study_id