Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
Key facts
- Who runs it
- Florida Institute for Human and Machine Cognition
- Where
- Pensacola, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 25 people, planned
- Started
- 20 Oct 2025
- Expected to end
- 1 Jun 2027
- Type of study
- Interventional
- Treatments tested
- Clinical Evaluation
- Plantar Pressure Biofeedback Gait Training
- Propulsion Biofeedback Gait Training
- Record updated
- 11 March 2026
Who can take part
- Age
- 45 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- History of amputation
- 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
- 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
- Active ulceration
- Medial column deformity
- Improper footwear for walking and community ambulation
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 90 years old?
Where in United States
- Florida Institute for Human and Machine CognitionPensacola, United StatesContact: Nicole K Rendos, PhDTaking people
About the trial
What the trial wants to find out
This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN).
Read full original descriptionShow less
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
The group in the trial
- Real-Time Biofeedback Walking TrialsTreatment being tested
Real-time biofeedback of propulsion and plantar pressure to measure the immediate effects of biofeedback on walking function and gait mechanics. Permuted block randomization (blocks of 4) will be used to allocate the order of the biofeedback stimulus (plantar pressure-intervention A or propulsion-intervention B). Participants will receive both interventions in session 3, but the order will be randomized.
Treatment: Clinical Evaluation, Plantar Pressure Biofeedback Gait Training, and Propulsion Biofeedback Gait Training
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06591780, who can take part
- Record updated
- 11 March 2026