Walking Function in 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
- 50 people, planned
- Started
- 5 Dec 2024
- Expected to end
- 31 Aug 2027
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Clinical Evaluation
- Evaluation of Passive Ankle Stiffness
- Gait Biomechanics
- Gait Biofeedback
- Plantar Pressure Biofeedback Gait Training
- Propulsion Biofeedback Gait Training
- Record updated
- 18 August 2026
Who can take part
- Age
- 45 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- Age 45+ years
- Able to walk 10-meters independently without an assistive device
- Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 1-minute at self-selected speed
- Diagnosis of DM
- Diagnosis of DPN by a physician
- Foot examination within the past 6 months to document ambulatory status
- Physician's clearance
Who cannot take part
- History of neurologic disease
- History of orthopaedic disease affecting the lower extremities
- History of injury or pain affecting the lower extremity or walking function within the past 6 months
- History of amputation
- 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 DM 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
- Individuals who are pregnant, prisoners, or not yet adults
- Inability to communicate with the investigators
- Inability to provide written informed consent
Where in United States
- Florida Institute for Human and Machine CognitionPensacola, United StatesContact: Nicole Rendos, PhDTaking people
About the trial
What the trial wants to find out
The purpose of this study is to 1) examine the differences in walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults with no known conditions; 2) examine if receiving feedback on walking form will help change walking patterns; and 3) examine the feasibility, safety, and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy.
The 3 groups in the trial
- Able-Bodied ParticipantsExisting treatment, for comparison
Able-bodied participants will complete a total of three study sessions. The three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with participants with DPN.
Treatment: Clinical Evaluation, Evaluation of Passive Ankle Stiffness, Gait Biomechanics, and Gait Biofeedback
- Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait TrainingTreatment being tested
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive plantar pressure biofeedback gait training first and propulsion biofeedback gait training at least three weeks later.
Treatment: Clinical Evaluation, Evaluation of Passive Ankle Stiffness, Gait Biomechanics, Gait Biofeedback, Plantar Pressure Biofeedback Gait Training, and Propulsion Biofeedback Gait Training
- Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait TrainingTreatment being tested
Participants with DPN will complete a total of seven study sessions. The first three sessions include a clinical evaluation, gait biomechanics, and gait biofeedback for comparison with able bodied participants. Sessions four through seven involve two different biofeedback training sessions followed by a retention gait analysis test 24-48 hours after training. Participants in this study are are randomized to receive propulsion biofeedback gait training first and plantar pressure biofeedback gait training at least three weeks later.
Treatment: Clinical Evaluation, Evaluation of Passive Ankle Stiffness, Gait Biomechanics, Gait Biofeedback, 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.
- Official title
- Walking Function in Individuals With Diabetic Peripheral Neuropathy: Biomechanical Mechanisms and Implications for Clinical Outcomes and Gait Retraining
- Record updated
- 18 August 2026