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

Not Applicable

Not yet recruiting

• Conditions: Diabetic Peripheral Neuropathy; Diabetes Mellitus; Diabetic Foot Ulcer

• Registration Number: NCT06591780
• Lead Sponsor: Emory University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-9-9
• Last Update Posted: 23 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Inclusion Criteria:<br><br> - Able to walk 10-meters independently without an assistive device<br><br> - Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 6<br> minutes at a self-selected speed<br><br> - Diagnosis of diabetes mellitus<br><br> - Diagnosis of diabetic peripheral neuropathy by a physician<br><br> - Foot examination within the past 6 months documenting ambulatory status<br><br> - Physician clearance<br><br>Exclusion Criteria:<br><br> - History of amputation<br><br> - Active ulceration<br><br> - Medial column deformity<br><br> - Severe cognitive impairment (MoCA < 10)<br><br> - Severe visual impairment<br><br> - History of Charcot osteoarthropathy<br><br> - History of posterior muscle group lengthening<br><br> - History of lower extremity joint replacement<br><br> - History of lower extremity and/or foot surgery affecting walking mechanics<br><br> - Orthopaedic problems of the lower limbs or spine due to other medical conditions<br> (not diabetes or DPN) that limit walking or cause pain during walking<br><br> - Improper footwear for walking and community ambulation<br><br> - Cardiovascular or medical condition affecting ability to walk safely<br><br> - History of unexplained dizziness or fainting in the past 2 months<br><br> - Allergy to adhesive tape or rubbing alcohol

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomechanical plantar pressure;Biomechanical Propulsion

Secondary Outcome Measures

Name	Time	Method
Changes induced by biofeedback in plantar pressure;Changes induced by biofeedback in propulsion;Changes induced by biofeedback in biomechanics during gait