Status:
RECRUITING
Walking Function in Diabetic Peripheral Neuropathy
Lead Sponsor:
Florida Institute for Human and Machine Cognition
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Diabetic Peripheral Neuropathy
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Over 34 million adults in the United States are living with Diabetes Mellitus (DM). Diabetic peripheral neuropathy (DPN) is the most common complication, affecting 50% of individuals with DM. Conseque...
Eligibility Criteria
Inclusion
- Inclusion Criteria for All Participants:
- 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
- Inclusion Criteria for Participants with DPN:
- Diagnosis of DM
- Diagnosis of DPN by a physician
- Foot examination within the past 6 months to document ambulatory status
- Physician's clearance
- Exclusion Criteria for Healthy Able-Bodied Individuals:
- History of neurologic disease
- History of orthopaedic disease affecting the lower extremities
- History of injury or pain affecting the lower extremity or walking function within the past 6 months
- Exclusion Criteria for All Participants:
- History of amputation
- Active 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
- Orthopaedic problems of the lower limbs or spine due to other medical conditions (not DM or DPN) that limit walking or cause pain during walking
- Improper footwear for walking and community ambulation
- Cardiovascular or medical condition 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
Exclusion
Key Trial Info
Start Date :
December 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05965336
Start Date
December 5 2024
End Date
March 1 2027
Last Update
July 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Institute for Human and Machine Cognition
Pensacola, Florida, United States, 32502