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

NCT04171973 | Completed

• 1 other identifier: 2019-A01903-54
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Disorder

Outcome Measures

Primary Outcomes (3)

• Number of collision

  The primary judgment criterion is the number of collisions on different standardized circuits in real condition versus virtual condition

  Day 1

• Number of collision

  The primary judgment criterion is the number of collisions on different standardized circuits in real condition versus virtual condition

  Day 8

• Number of collision

  The primary judgment criterion is the number of collisions on different standardized circuits in real condition versus virtual condition

  Day 15

Secondary Outcomes (8)

• 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

Study Arms (2)

Driving an electric wheelchair in real condition

OTHER

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.

Device: Driving an electric wheelchair in real condition

Driving an electric wheelchair in virtual condition

EXPERIMENTAL

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.

Device: Driving an electric wheelchair in virtual condition

Interventions

Driving an electric wheelchair in real condition 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 real condition

Driving an electric wheelchair in virtual condition DEVICE

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

Driving an electric wheelchair in virtual condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Pôle Saint Hélier: lead
• INSA Rennes: collaborator

Study Sites (1)

Pole Saint-Hélier

Rennes, Brittany Region, 35000, France

Location

Related Publications (1)

• 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.

  PMID: 38654367 DERIVED

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Philippe Gallien, Doctor

  Pôle Saint Hélier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Neither patients nor evaluators can be unaware of which group they are in.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a pilot, prospective, monocentric, controlled, randomized, open-arms, open-ended, minimal risk and minimal constraint study (RIPH category 2).

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 21, 2019
• Study Start: January 14, 2020
• Primary Completion: January 29, 2020
• Study Completion: January 29, 2020
• Last Updated: January 31, 2020

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)