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

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

Patrocinadores

Patrocinador principal: Pôle Saint Hélier

Colaborador: Institut National des Sciences Appliquées de Rennes (INSA)

Fuente Pôle Saint Hélier
Resumen breve

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.

Descripción detallada

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.

Estado general Completed
Fecha de inicio January 14, 2020
Fecha de Terminación January 29, 2020
Fecha de finalización primaria January 29, 2020
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Number of collision Day 1
Number of collision Day 8
Number of collision Day 15
Resultado secundario
Medida Periodo de tiempo
Driving Speed Day 1, Day 8 and Day 15
Wheelchair Skill Test (WST) Day 1, Day 8 and Day 15
NASA-Task Load Index Day 1, Day 8 and Day 15
Ease of Use Questionnaire Day 1, Day 8 and Day 15
Unified theory of acceptance of technology questionnaire (UTAUT) Day 1, Day 8 and Day 15
Igroup Presence Questionnaire (IPQ) Day 1, Day 8 and Day 15
The learning effect Day 1, Day 8 and Day 15
Graybiel score Day 1, Day 8 and Day 15
Inscripción 31
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Driving an electric wheelchair in real condition

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

Etiqueta de grupo de brazo: Driving an electric wheelchair in real condition

Tipo de intervención: Device

Nombre de intervención: Driving an electric wheelchair in virtual condition

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

Etiqueta de grupo de brazo: Driving an electric wheelchair in virtual condition

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Philippe Gallien, Doctor Principal Investigator Pôle Saint Hélier
Ubicación
Instalaciones: Pole Saint-Hélier
Ubicacion Paises

France

Fecha de verificación

November 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Driving an electric wheelchair in real condition

Tipo: Other

Descripción: 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.

Etiqueta: Driving an electric wheelchair in virtual condition

Tipo: Experimental

Descripción: 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.

Acrónimo SIMADAPT1
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Crossover Assignment

Descripción del modelo de intervención: It is a pilot, prospective, monocentric, controlled, randomized, open-arms, open-ended, minimal risk and minimal constraint study (RIPH category 2).

Propósito primario: Other

Enmascaramiento: None (Open Label)

Descripción de enmascaramiento: Neither patients nor evaluators can be unaware of which group they are in.

Fuente: ClinicalTrials.gov