User-friendliness of a Portable Driving Simulator to Retrain Impaired Driving Skills in Stroke Survivors and in Individuals With Parkinson's Disease and Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT03969927

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 17 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Low-Fidelity PDS

Compared with

  • High Fidelity Fixed-Base Simulator

What it measured

Main measures

  • User-Friendliness

    Assessed at the End of visit 2, visit 3, and visit 4. These visits will take place over an average of one week.

  • Simulator Sickness

    Assessed during visit 1, visit 2, visit 3, visit 4, and visit 5. These visits will take place over an average of one week.

  • Driving Performance

    Assessed during visit 1, and visit 5. These visits will take place over an average of one week.

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 25 to 75

Show the full criteria

Inclusion criteria

* Diagnosis of a first ever stroke, PD, or MS * Valid driver's licenses, ≥ 3 years driving experience, * Mini-mental State Examination score ≥24, and * Binocular acuity of at least 20/60 in compliance with state of Kansas driving laws

Exclusion criteria

- Diagnosis of traumatic brain injury or any other neurological condition apart from stroke, PD, and MS.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The use of simulators to retrain driving skills of patients with stroke, Parkinson's disease (PD), or multiple sclerosis (MS) is very limited because of cost, space required, and incidence of simulator sickness in high fidelity simulators. The Principal investigator recently developed a low cost low fidelity portable driving simulator (PDS). In this pilot study, the study team will (1) determine the ease of use and occurrence of simulator sickness while operating the low fidelity PDS in a clinic setting and (2) the efficacy of the low fidelity PDS to reproduce the benefits from retraining impaired driving skills of stroke survivors in a high-fidelity simulator. Participants: 30 participants, separated according to neurological condition including stroke, PD, or MS, will be randomly allocated to either the PDS or fixed-base high-fidelity simulator training. Each participant will undergo a pre-training evaluation, five hours of designated training and a post-training assessment, similar to the pre-training evaluation. Data will be analyzed according to study aims. The investigators hypothesize that the simple set up of the PDS will make it easier to use and better decrease the incidence of simulator sickness that typically leads to stopping therapy than the high-fidelity simulator. The investigators hypothesize that improvements in lane maintenance, adherence to speed limits, reaction to traffic lights, and overall reaction time after training using the PDS will not be significantly different from improvements observed after training using the high-fidelity driving simulator.

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History

    1. Started

      Aug 2019

    2. Main results due

      Jun 2025

    3. Finished

      Jun 2025

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