Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy

Launched by FLORIDA INSTITUTE FOR HUMAN AND MACHINE COGNITION · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method called biofeedback to help improve walking ability in people with Diabetic Peripheral Neuropathy (DPN), a condition that affects the nerves in the feet and can make walking difficult. The researchers want to understand how walking mechanics, like pressure on the feet while walking, can be improved with real-time feedback provided on a screen. Participants will take part in various activities, including filling out questionnaires, undergoing physical examinations, and walking on a special treadmill that tracks their movements. They will receive visual and sound cues to help them adjust their walking patterns during the session.

To join this study, participants must be able to walk 10 meters on their own without any aids and have been diagnosed with diabetes and DPN by a doctor. They'll also need to be in good enough health to walk on a treadmill for about 6 minutes. However, there are some conditions that may exclude someone from participating, such as having a recent amputation or severe cognitive or visual impairments. This trial is currently recruiting participants of all genders aged between 16 and 87. If someone is interested, they can expect a supportive environment where their walking abilities are assessed and improved with the help of innovative technology.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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