NCT06591780 Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
| NCT ID | NCT06591780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida Institute for Human and Machine Cognition |
| Condition | Diabetic Peripheral Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-10-20 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-10-20 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 abnormal plantar pressure and propulsion during gait in individuals with DPN * Biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN The participants will be required to complete * Questionnaires * Clinical examination * 3-Dimensional gait analysis on an instrumented treadmill * Visual and auditory biofeedback on the participant's propulsion and plantar pressure metrics provided by a projector screen during walking
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
Contact & Investigator
Nicole K Rendos, PhD
PRINCIPAL INVESTIGATOR
Florida Institute for Human and Machine Cognition
Frequently Asked Questions
Who can join the NCT06591780 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 90 Years, studying Diabetic Peripheral Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06591780 currently recruiting?
Yes, NCT06591780 is actively recruiting participants. Contact the research team at nrendos@ihmc.org for enrollment information.
Where is the NCT06591780 trial being conducted?
This trial is being conducted at Pensacola, United States.
Who is sponsoring the NCT06591780 clinical trial?
NCT06591780 is sponsored by Florida Institute for Human and Machine Cognition. The principal investigator is Nicole K Rendos, PhD at Florida Institute for Human and Machine Cognition. The trial plans to enroll 25 participants.