Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders (SIMADAPT2)
29 ottobre 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
25
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Bretagne
-
Rennes, Bretagne, Francia, 35000
- Pôle Saint-Hélier
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Immersive condition
Performance driving wheelchair in immersive condition (in Cave automatic environment or with HMD)
|
Driving course with obstacles in a CAVE system
Driving course with obstacles with a virtual reality headset
|
|
Sperimentale: Non Immersive condition
Performance driving wheelchair in non immersive condition (with screen and physical simulator or screen only)
|
Driving course with obstacles on a screen with physical simulator
Driving course with obstacles on a screen only
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
number of the collisions with the environment on the standardised circuit
Lasso di tempo: During the driving course, from the beginning to the end of the circuit.
|
It will be compared in 4 conditions :
|
During the driving course, from the beginning to the end of the circuit.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
the time taken to complete the course
Lasso di tempo: During the driving course, from the beginning to the end of the circuit.
|
It will be measured, in minutes and seconds, under the various conditions
|
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)
Lasso di tempo: 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
|
|
visual information (VICON® system)
Lasso di tempo: During the driving course, from the beginning to the end of the circuit.
|
The number of head movement will be measured by VICON system.
|
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
Lasso di tempo: 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
|
|
sensation of immersion and the feeling of presence in a virtual situation (Igroup Presence Questionnaire IPQ)
Lasso di tempo: Immediately after intervention
|
It will be evaluated and compared by Igroup Presence Questionnaire IPQ.
|
Immediately after intervention
|
|
discomfort of driving in immersive reality,
Lasso di tempo: Immediately after intervention
|
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
|
|
satisfaction of the testers and the acceptability of the various conditions simulated
Lasso di tempo: 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
|
|
the acceptability of the various conditions simulated
Lasso di tempo: Immediately after intervention
|
Evaluation of acceptability with Unified Theory of Acceptance and Use of Technology (UTAUT) after each condition
|
Immediately after intervention
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Philippe GALLIEN, Pole Saint Helier
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
10 maggio 2021
Completamento primario (Effettivo)
26 ottobre 2021
Completamento dello studio (Effettivo)
26 ottobre 2021
Date di iscrizione allo studio
Primo inviato
3 maggio 2021
Primo inviato che soddisfa i criteri di controllo qualità
17 maggio 2021
Primo Inserito (Effettivo)
20 maggio 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 novembre 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 ottobre 2021
Ultimo verificato
1 maggio 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2021-A00120-41
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .