NCT04648735

Brief Summary

Driving is an important activity for older adults because it frequently relates to personal independence and wellbeing. This study compared the driving behaviors of older drivers with normal cognition and with MCI in unfamiliar driving situations and difficult maneuvers, and explored the practice effect on driving performance of drivers with MCI. This study used an observational, cross-section research design.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

3 years

First QC Date

November 22, 2020

Last Update Submit

December 2, 2020

Conditions

Keywords

Mild Cognitive Impairmentdementiadriving fitnessdriving rehabilitation

Outcome Measures

Primary Outcomes (3)

  • driving evaluation

    The driving evaluation follows the same format of the governmental on-road driving tests in Taiwan. The test included 8 driving maneuvers on a standardized driving course: pre-drive checks and actions before starting to drive, crosswalk crossing, railway crossing, parking in reverse, parallel parking at roadside, driving forward and backward on a curving road (S-bend), ascending and descending slope, driving around the test circuit. https://tpcmv.thb.gov.tw/english/ServicesEng/LicenseEng/LicenseTest/t03.htm The participants were scored according to governmental driving licensure exam guidelines. Scoring on individual driving maneuver is weighted. Depending on the type of error, 8, 16 or 32 points were deducted from 100, for example, 32 points for getting too close to pedestrian lane. The minimal score is 0 and the maximal score is 100. Higher scores means better performance.

    The participant was scored immediately after practices.

  • control of steering wheel

    An Android smart phone (LG Nexus 5) was used to record on-road driving behaviors. The phone was equipped with a global positioning system (GPS) mobile application, J device. J device compiled the accelerator, gyroscope, and GPS data at a frequency of 50 Hz. The J device gyroscope data showed changes in driving direction, indicating whether the driver's control of the steering wheel was steady. Lower numbers in gyroscope data meant that the steering wheel was moved little, thus indicating few changes in direction or steadier hands on the steering wheel

    during the practices

  • control of speed

    An Android smart phone (LG Nexus 5) was used to record on-road driving behaviors. The phone was equipped with a global positioning system (GPS) mobile application, J device (Tsao et al., 2015). J device compiled the accelerator, gyroscope, and GPS data at a frequency of 50 Hz. The J device accelerator data represented changes in the speed of the car, indicating the degree of control the driver had over the accelerator and brake; i.e., whether the driver maintained a steady speed or caused frequent changes in speed. A lower number of accelerations meant that the driver had smaller acceleration changes in a set period of time, indicating a more constant speed and thus better accelerator and brake control. A higher number of accelerations meant that the driver had larger acceleration changes in a set period of time, indicating greater variation in speed and less control of the accelerator and brake.

    during the practices

Study Arms (2)

Drivers with cognitive impairments

EXPERIMENTAL

The participants firstly completed a questionnaire of driving history and perceived driving competence, followed with a clinical physical and cognitive-perceptual assessment battery conducted by an occupational therapist to note any potential deficits that might affect driving performance. The participants, on a separate visit, completed three practice runs of a closed-circuit standardized course that included 8 driving maneuvers, followed by an on-road driving in the community fir 30 minutes.

Other: driving evaluation and practice

drivers with normal cognition

ACTIVE COMPARATOR

The participants firstly completed a questionnaire of driving history and perceived driving competence, followed with a clinical physical and cognitive-perceptual assessment battery conducted by an occupational therapist to note any potential deficits that might affect driving performance. The participants, on a separate visit, completed three practice runs of a closed-circuit standardized course that included 8 driving maneuvers, followed by an on-road driving in the community fir 30 minutes.

Other: driving evaluation and practice

Interventions

The participants completed the actual driving with a licensed driving instructor on the passenger side in the car and with a dual-control, automatic-transmission car. Each participant completed three runs of the same route. The first twos were practices to familiarize themselves with the course. The driving instructor graded them on the third run. Each trial took about 10 minutes. The participants were scored according to governmental driver test guidelines. Scoring on individual driving maneuver is weighted. Depending on the type of error, 8, 16 or 32 points were deducted from 100, for example, 32 points for getting too close to pedestrian lane, running a red light or railroad crossing, and 8 points for stopping in S-curve forward and backward. 70 or above is considered as a pass. The occupational therapists in the backseat recorded driving behaviors, including whether the driver checked rear and side mirrors, excessive sweating, distractibility, number of adjustments, etc.

Drivers with cognitive impairmentsdrivers with normal cognition

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age of at least 50 years
  • possession of a valid driving license and driving experience for at least 15 years
  • regular driving habit, defined as at least once a week, and
  • no reported significant driving issues

You may not qualify if:

  • reported health conditions that could potentially compromise driving competence, such as stroke, Parkinson's disease or other neuromuscular diseases
  • visual impairments without correction, or
  • physical impairments found in physical function assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cheng YH, Pai MC, Shih BH, Jan SS, Lin CY, Chang LH. Driving practice effects for older drivers with mild cognitive impairment: A preliminary study. Scand J Occup Ther. 2023 May;30(4):550-558. doi: 10.1080/11038128.2023.2184420. Epub 2023 Mar 11.

MeSH Terms

Conditions

Cognitive DysfunctionDementiaLymphoma, Follicular

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Ling-Hui Chang, Ph.D

    Department of Occupational Therapy, NCKU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the participant and the outcome assessor were both blind to the design.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: an observational, cross-sectional research design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 22, 2020

First Posted

December 1, 2020

Study Start

August 1, 2015

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share