Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders (SIMADAPT2)
29 de octubre de 2021 actualizado por: Pôle Saint Hélier
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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
25
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Bretagne
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Rennes, Bretagne, Francia, 35000
- Pôle Saint-Hélier
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Immersive condition
Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD)
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Driving course with obstacles in a CAVE system
Driving course with obstacles with a virtual reality headset
|
|
Experimental: Non Immersive condition
Performance driving wheelchair in non immersive condition (with screen and physical simulator or screen only)
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Driving course with obstacles on a screen with physical simulator
Driving course with obstacles on a screen only
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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number of the collisions with the environment on the standardised circuit
Periodo de tiempo: During the driving course, from the beginning to the end of the circuit.
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It will be compared in 4 conditions :
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During the driving course, from the beginning to the end of the circuit.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
the time taken to complete the course
Periodo de tiempo: During the driving course, from the beginning to the end of the circuit.
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It will be measured, in minutes and seconds, under the various conditions
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During the driving course, from the beginning to the end of the circuit.
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evaluation of driving performance with Wheelchair Skill Test (WST-Q-T 5.1)
Periodo de tiempo: Immediately after intervention
|
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 |
Immediately after intervention
|
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visual information (VICON® system)
Periodo de tiempo: During the driving course, from the beginning to the end of the circuit.
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The number of head movement will be measured by VICON system.
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During the driving course, from the beginning to the end of the circuit.
|
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the cognitive load of carrying out the circuit with National Aeronautics and Space Administration Task Load Index
Periodo de tiempo: Immediately after intervention
|
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)
|
Immediately after intervention
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sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)
Periodo de tiempo: Immediately after intervention
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It will be evaluated and compared by Igroup Presence Questionnaire IPQ.
|
Immediately after intervention
|
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discomfort of driving in immersive reality,
Periodo de tiempo: Immediately after intervention
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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. |
Immediately after intervention
|
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satisfaction of the testers and the acceptability of the various conditions simulated
Periodo de tiempo: Immediately after intervention
|
Patients will be asked to rate their satisfaction on a scale of 0 to 10, with 10 being very satisfied.
|
Immediately after intervention
|
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the acceptability of the various conditions simulated
Periodo de tiempo: Immediately after intervention
|
Evaluation of acceptability with Unified Theory of Acceptance and Use of Technology (UTAUT) after each condition
|
Immediately after intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Philippe GALLIEN, Pole Saint Helier
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de mayo de 2021
Finalización primaria (Actual)
26 de octubre de 2021
Finalización del estudio (Actual)
26 de octubre de 2021
Fechas de registro del estudio
Enviado por primera vez
3 de mayo de 2021
Primero enviado que cumplió con los criterios de control de calidad
17 de mayo de 2021
Publicado por primera vez (Actual)
20 de mayo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de noviembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
29 de octubre de 2021
Última verificación
1 de mayo de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2021-A00120-41
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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