Status:
RECRUITING
Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
Lead Sponsor:
Florida Institute for Human and Machine Cognition
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetic Peripheral Neuropathy
Diabetes Mellitus
Eligibility:
All Genders
45-90 years
Phase:
NA
Brief Summary
This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN). The primary goals are to evaluate: * Biomechanical mechanisms contributing to abnor...
Detailed Description
Over 38 million adults in the United States (\~1 in 7) are living with Diabetes Mellitus (DM), of which diabetic peripheral neuropathy (DPN) is the most common complication, affecting more than 50% of...
Eligibility Criteria
Inclusion
- Able to walk 10-meters independently without an assistive device
- Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 6 minutes at a self-selected speed
- Diagnosis of diabetes mellitus
- Diagnosis of diabetic peripheral neuropathy by a physician
- Foot examination within the past 6 months documenting ambulatory status
- Physician clearance
Exclusion
- History of amputation
- Active ulceration
- Medial column deformity
- Severe cognitive impairment (MoCA \< 10)
- Severe visual impairment
- 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 diabetes 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06591780
Start Date
August 1 2025
End Date
December 31 2026
Last Update
August 7 2025
Active Locations (1)
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1
Florida Institute for Human and Machine Cognition
Pensacola, Florida, United States, 32502