STTR Phase 2 Project funded by NIH
Phase 2 project start date: Jan. 2003 (Phase 1 project dates: 1999-2001)
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STIsim
Drive. More details on the simulator we use can be found on the
STISIM
web site
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Project description
Brain injury (BI) due to accident or stroke frequently results in cognitive impairment, reducing an individual's ability to judge driving situations accurately, and affecting the metacognitive skills necessary to self-assess their capacity for safe driving. Individuals with severe cognitive impairment are easily identified as unsafe drivers. Those with mild to moderate deficits are more difficult to categorize reliably. It is, therefore, more difficult for the rehabilitation team to balance the possible increased risk to the community and to the impaired individual against the anticipated benefits that a return to driving may hold for that individual.
Interactive driving simulators can present a diversity of driving challenges in a safe environment. Interactive simulators produce reliable, objective measurement of driving behaviors, allowing rehabilitation professionals to ascertain the least restrictive safe driving option for a given individual. An interactive simulator enables a person with cognitive impairment to experience realistic outcomes of his or her performance, providing an opportunity for individuals to confront errors and more accurately self-assess their driving abilities. Accurate self-appraisal may help resolve differences between the patient's self-assessment of driving ability and that offered by the rehabilitation professional.
The long-term goal of this project is to develop and commercialize STISIM Drive, a relatively low-cost driving simulator that uses standard PC technology. Although ultimately this simulator may be useful for individuals with a wide range of motor, sensory and information processing disabilities, the current project focuses on applications to persons with adult onset brain injury and resulting cognitive deficits.
In Phase I of this project, we implemented several engineering changes to STISIM Drive, developed protocols for using the simulator with subjects with mild to moderate cognitive disabilities resulting from brain injury, and pilot tested the protocols on five brain-injured and five matched, non-disabled subjects. In the current Phase II project, we will further enhance the simulator and will conduct a multi-center clinical trial to demonstrate STISIM Drive's viability as a rehabilitation tool for this patient population. The purpose of the Phase II project is to validate the simulator as a tool. We will let others determine how this tool is best applied to specific tasks such as training and licensing. Commercialization and market introduction will be conducted after Phase II is complete.
The specific aims of Phase II are to:
1. Update the hardware and software of STISIM Drive to improve the face validity of the driving experience and to ease the task of data analysis. The improvements are based upon what we learned during the Phase I study and include:
1.1 Increasing the realism of STISIM Drive.
1.2 Using feedback from clinicians participating in the multi-center trial to make improvements in the usability of STISIM Drive. Creating improved data output formats that are clinically meaningful and easy to interpret.
1.4 Creating a driving scenario for the Phase II clinical trials that incorporates a variety of normal and extraordinary driving challenges. Data generated from driving this scenario will provide a normed performance data base that others can use in their evaluation programs.
2. Through a multi-center clinical trial, answer four key questions that will help determine simulator efficacy as an assessment tool in a clinical setting. These questions are:
2.1 Concurrent validity: Is performance on the driving simulator similar to on-road performance? This experiment requires both simulator and on-road tests.
2.2 Test-retest reliability: Do you get similar simulator session results when the test is repeated a second time on the same subject with a 2 week delay between test sessions? Favorable results will enable clinicians to determine how patient performance changes over time.
2.3 Discriminant validity: Can the simulator discriminate between the driving ability of subjects with different cognitive impairments? That is, are scores from simulator runs consistent with other test methods used to categorize the severity of cognitive impairment?
2.4 Face validity: Do clients who drive the simulator accept that simulator driving is similar to real, on-road driving?
3. Conduct a pilot study to determine if the simulator can be used therapeutically
to change a driver's self-awareness of driving ability. This study will show
whether feedback given by the simulator and by the driving evaluator can improve
the accuracy of self-appraisal of driving skills. We suspect that the simulator
will ultimately have the most value as a therapeutic tool in a rehabilitation
clinic setting and we are eager to see if use of the simulator with feedback
can indeed impact self-awareness for brain-injured persons. This study is designed
to not be linked to any of the validity tests listed in Aim 2.
For more information about this project, please feel free to contact the project P.I., William Durfee, Department of Mechanical Engineering, University of Minnesota, wkdurfee@umn.edu