Actively Recruiting

Phase Not Applicable
Age: 45Years +
All Genders
Healthy Volunteers
NCT05965336

Walking Function in Diabetic Peripheral Neuropathy

Led by Florida Institute for Human and Machine Cognition · Updated on 2025-07-24

50

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

Sponsors

F

Florida Institute for Human and Machine Cognition

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to 1) examine the differences in walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults with no known conditions; 2) examine if receiving feedback on walking form will help change walking patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy.

CONDITIONS

Official Title

Walking Function in Diabetic Peripheral Neuropathy

Who Can Participate

Age: 45Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45+ years
  • Able to walk 10-meters independently without an assistive device
  • Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 1-minute at self-selected speed
  • Diagnosis of diabetes mellitus (for participants with diabetic peripheral neuropathy)
  • Diagnosis of diabetic peripheral neuropathy by a physician
  • Foot examination within the past 6 months to document ambulatory status (for participants with diabetic peripheral neuropathy)
  • Physician's clearance (for participants with diabetic peripheral neuropathy)
Not Eligible

You will not qualify if you...

  • History of neurologic disease (for healthy able-bodied individuals)
  • History of orthopedic disease affecting the lower extremities (for healthy able-bodied individuals)
  • History of injury or pain affecting the lower extremity or walking function within the past 6 months (for healthy able-bodied individuals)
  • History of amputation
  • Active foot ulceration
  • Medial column deformity
  • History of Charcot osteoarthropathy
  • History of posterior muscle group lengthening
  • History of lower extremity joint replacement
  • History of lower extremity and/or foot surgery affecting walking mechanics
  • Orthopedic problems of the lower limbs or spine due to other medical conditions (not diabetes or diabetic peripheral neuropathy) that limit walking or cause pain during walking
  • Improper footwear for walking and community ambulation
  • Cardiovascular or medical conditions affecting ability to walk safely
  • History of unexplained dizziness or fainting in the past 2 months
  • Allergy to adhesive tape or rubbing alcohol
  • Individuals who are pregnant, prisoners, or not yet adults
  • Inability to communicate with the investigators
  • Inability to provide written informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Florida Institute for Human and Machine Cognition

Pensacola, Florida, United States, 32502

Actively Recruiting

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Research Team

N

Nicole Rendos, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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