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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- User-Friendliness
研究概览
简要总结
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.
详细描述
Aims: The aims of the proposed study are to determine (1) the ease of use and development of simulator sickness while operating the low fidelity Portable Driving Simulator (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, persons with Parkinson's Disease (PD) or multiple sclerosis (MS) in a high-fidelity fixed-base simulator.
Hypotheses: For the first study aim 1, the investigators hypothesize that the simple set up of the PDS will make it easier to use and better mitigate incidence of simulator sickness that typically leads to attrition than in a high-fidelity simulator.
For study aim 2, 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.
Background: Currently, simulator-based training is the method with the best evidence of retraining impaired driving-related skills after stroke and with promise in individuals with Parkinson's disease (PD) or multiple sclerosis (MS). Driving simulators enable patients to retrain impaired driving skills in a context that evokes and ''mimics'' the perceptual, cognitive, and motor processes used in real-world driving. The fact that real-world traffic and driving situations can be presented many times over, without any safety risk, under full experimenter or clinician control, and with ''instant replay'' possibility to augment feedback enhances the utility of the driving simulator as an ideal tool for driving rehabilitation.
However, the use of simulators to retrain driving skills of patients with stroke, PD, or MS has been very limited because of three major reasons. The cost of currently available driving simulators (between $50,000 to $500,000), the space needed to house the simulators (15 to 50 square feet), and the incidence of simulator sickness (rate = 5 - 25%) in high-fidelity simulators. The principal investigator recently developed a low cost ($10,000) low fidelity portable driving simulator (PDS) in the University of Kansas Laboratory for Advanced Rehabilitation Research in Simulation (LARRS) that measures 25.5" Wide, 32.5" High, and 25" Deep and requires only approximately 4 square feet of space.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The participant and the research assistant providing the training are not masked. The rest of the study conductors are masked regarding participant arm allocation.
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- Diagnosis of traumatic brain injury or any other neurological condition apart from stroke, PD, and MS.
研究组 & 干预措施
High Fidelity Fixed-Base Simulator Training
Individuals with stroke, PD, or MS
干预措施: High Fidelity Fixed-Base Simulator (Device)
Low-Fidelity PDS Training
Individuals with stroke, PD, or MS
干预措施: Low-Fidelity PDS (Device)
结局指标
主要结局
User-Friendliness
时间窗: Assessed at the End of visit 2, visit 3, and visit 4. These visits will take place over an average of one week.
User-Friendliness will be assessed using a User-Friendliness Survey which is a Likert scale. \[1-5 scale with 1 representing the lowest degree of user-friendliness and 5 representing the highest degree of user-friendliness\]
Simulator Sickness
时间窗: Assessed during visit 1, visit 2, visit 3, visit 4, and visit 5. These visits will take place over an average of one week.
Simulator Sickness and symptoms of Simulator Sickness will be assessed using questionnaire adapted from the 1993 Kennedy et al Simulator Sickness Questionnaire. \[This will be reported from a 0-228.14 scale with 0 representing the lowest possible degree of Simulator Sickness and 228.14 indicating the greatest possible degree of Simulator Sickness\]
Driving Performance
时间窗: Assessed during visit 1, and visit 5. These visits will take place over an average of one week.
Driving Performance will be assessment by a Driving rehabilitation specialist before and after each participant undergoes training. The participants will be tested on the high-fidelity driving simulator and the driving simulator provide objective measurements of lane position maintenance, adherence to speed limits, reaction to traffic lights, and overall reaction time.
次要结局
未报告次要终点