Actively Recruiting

Phase Not Applicable
Age: 25Years - 69Years
All Genders
ID06739135

Enabling People with Diabetic Neuropathy to Drive Safely: a Proof of Concept Randomised Controlled Trial

Led by Manchester Metropolitan University · Updated on 2024-12-18

115

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a visual feedback intervention to improve how people with diabetic peripheral neuropathy (DPN) use the accelerator pedal while driving. This proof-of-concept randomized controlled trial aims to see if giving visual warnings during simulated driving reduces the time drivers spend pressing the accelerator more than halfway down. The study also compares drivers with DPN who receive the intervention or no feedback, and includes a group with diabetes but no neuropathy for comparison. Participants will attend up to six visits one month apart at a driving simulator. Those with DPN who press the accelerator beyond 9 degrees in the initial assessment will be randomly assigned to receive visual feedback training or no feedback. Drivers in the intervention group will experience a warning symbol when pressing the accelerator too far, meant to help them moderate pedal use. Control group drivers have three visits to assess driving without feedback. Drivers without neuropathy have one assessment visit only. During visits, participants undergo driving simulator tests including practice drives, baseline assessments, and drives with or without visual feedback. Additional tests at the first visit include peripheral neuropathy assessments, proprioception measurement, blood glucose testing, and collection of demographic and driving history information. Researchers measure outcomes such as the percentage of time the accelerator is pressed beyond the threshold and vehicle control. Participant feedback is collected after the final visit to improve the program. The total study duration extends up to six months for intervention participants.

CONDITIONS

Brief Title

Driving with Neuropathy

Who Can Participate

Age: 25Years - 69Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand English and provide informed consent
  • Current full UK driving licence held for at least 5 years
  • Drives a car at least once per week
  • Diagnosed with type 2 diabetes and diabetic peripheral neuropathy
  • Diagnosed with type 2 diabetes only (no diagnosed diabetic peripheral neuropathy)
Not Eligible

You will not qualify if you...

  • Active foot ulcer on either foot
  • Lower limb amputation involving more than two toes on the right foot
  • Dementia
  • Participating in another research study that may affect safety or scientific integrity, such as a pharmaceutical trial affecting driving ability

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment and Randomization

Duration - 1 day

Participants undergo a baseline driving assessment including practice and assessment drives, neuropathy and proprioception testing, blood glucose testing, and demographic data collection. Participants with diabetic peripheral neuropathy (DPN) who meet criteria are randomized to intervention or control groups.

1 visit (in-person)

Intervention

Duration - 6 months with monthly visits

Participants with DPN in the intervention group receive visual feedback training during simulated driving sessions to reduce excessive use of the accelerator pedal. Each session includes multiple driving tasks with and without feedback.

6 visits (in-person), approximately 1 month apart

Control Group Driving Sessions

Duration - 6 months with visits timed to intervention group

Participants with DPN in the control group complete simulated driving assessments without visual feedback to match the timing of the intervention group's visits.

3 visits (in-person), timed to match visits 1, 3, and 6 of the intervention group

No/Low DPN Group Assessment

Duration - 1 day

Participants with diabetes but no diagnosed neuropathy complete a single visit with simulated driving assessment and baseline testing without intervention.

1 visit (in-person)

Post-Driving Participant Feedback

Duration - At the final visit

At the final visit, participants provide feedback on their experience of the driving simulator sessions and visual feedback training if applicable.

1 visit (in-person) at last session

Trial Site Locations

Total: 1 location

1

Manchester Metropolitan University

Manchester, United Kingdom

Actively Recruiting

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Research Team

M

Maaike Esselaar, PhD

D

Dilwyn Marple-Horvat, DPhil

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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