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Comparison of Power Wheelchair Driving Performance Under Immersive and Non-immersive Conditions With Drivers With Neurological Disorders (SIMADAPT2)

29 oktober 2021 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

25

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Bretagne
      • Rennes, Bretagne, Frankrike, 35000
        • Pôle Saint-Hélier

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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
Experimentell: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
number of the collisions with the environment on the standardised circuit
Tidsram: During the driving course, from the beginning to the end of the circuit.

It will be compared in 4 conditions :

  • immersive 1: physical simulator and CAVE_condition A1
  • immersive 2: physical simulator and virtual reality helmet_condition A2
  • non-immersive 1: screen and physical simulator_condition B1
  • non-immersive 2: screen only without simulator_condition B2 Day 1 : A + B Day 8 : A + B
During the driving course, from the beginning to the end of the circuit.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
the time taken to complete the course
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: Immediately after intervention
It will be evaluated and compared by Igroup Presence Questionnaire IPQ.
Immediately after intervention
discomfort of driving in immersive reality,
Tidsram: 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
Tidsram: 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
Tidsram: Immediately after intervention
Evaluation of acceptability with Unified Theory of Acceptance and Use of Technology (UTAUT) after each condition
Immediately after intervention

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Samarbetspartners

Utredare

  • Huvudutredare: Philippe GALLIEN, Pole Saint Helier

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

10 maj 2021

Primärt slutförande (Faktisk)

26 oktober 2021

Avslutad studie (Faktisk)

26 oktober 2021

Studieregistreringsdatum

Först inskickad

3 maj 2021

Först inskickad som uppfyllde QC-kriterierna

17 maj 2021

Första postat (Faktisk)

20 maj 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 november 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 oktober 2021

Senast verifierad

1 maj 2021

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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