Driving Ability in Patients With CMT 1A

Not Applicable

Completed

• Conditions: CMT 1A
• Interventions: Device: UIHC Driving Simulator

• Registration Number: NCT02357355
• Lead Sponsor: Jerath U Nivedita

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-11-01
• Study First Submitted: 2015-01-13
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-06
• Primary Completion: 2016-07-01
• Study Completion: 2016-07-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Group	UIHC Driving Simulator	Patients without CMT 1A who are our normal controls will undergo a driving simulation study. The intervention will be the SIREN driving simulator.
CMT 1A Group	UIHC Driving Simulator	Patients with CMT 1A will undergo a driving simulation study. The intervention will be the SIREN driving simulator.

Primary Outcome Measures

Name	Time	Method
Driving Error Rate	1 year

Secondary Outcome Measures

Name	Time	Method
Deceleration speed	1 year
Time to braking	1 year
Time to apply steering maneuvers	1 year

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States