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临床试验/NCT02357355
NCT02357355已完成不适用

Driving Ability in Patients With CMT 1A

Jerath U Nivedita2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
Driving Error Rate

研究概览

简要总结

Charcot Marie Tooth 1A (CMT 1A) is a common inherited disorder of the nerves in the body. The disease can result in difficulties with strength and balance as well as in foot deformities such as high arches, hammer toes, and tight ankles. Because of these difficulties, the disease may affect driving, especially because driving requires quick responses at times such as slamming on the brakes or turning the steering wheel quickly. The following study determines driving performance in individuals who have CMT 1A.

详细描述

Individuals with CMT 1A will drive in a driving simulator, which involves a car located in a room in the University of Iowa Hospitals and Clinics (UIHC). Individuals will drive in the car as if they are driving in real life and the whole experience is like playing a car video game with a big animated screen. The driving results will be compared to similar aged patients who don't have CMT 1A and have also taken the driving test. If patients with CMT 1A do have driving difficulties compared to those who do not have CMT 1A, the results of the study will try to help patients with CMT1A drive better by ultimately creating devices that might help them use the steering wheel or brake pedal in a safer way.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have CMT 1A
  • Have a valid driver's license
  • Exclusion criteria:
  • History of other types of neuropathy (other than CMT 1A)
  • History of blindness, seizures, or stroke, dementia/cognitive dysfunction

排除标准

  • 未提供

结局指标

主要结局

Driving Error Rate

时间窗: 1 year

次要结局

  • Deceleration speed(1 year)
  • Time to braking(1 year)
  • Time to apply steering maneuvers(1 year)

研究者

发起方
Jerath U Nivedita
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jerath U Nivedita

PI

University of Iowa

研究点 (2)

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