NCT05965336 · Florida Institute for Human and Machine Cognition
Walking Function in Diabetic Peripheral Neuropathy
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Clinical Evaluation
A clinical evaluation occurs at the first study session. The clinical evaluation assesses walking function and mobility, lower extremity, sensation, health-related quality of life (HRQoL) and foot function. Session 2 will be a dynamometer-based evaluation of passive ankle stiffness and 3-dimensional gait analysis to evaluate baseline biomechanics. During Session 3, real-time biofeedback conditions will be used to measure the immediate effects on walking function.
OTHER
Evaluation of Passive Ankle Stiffness
Participants will be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. EMG activity will be recorded from lower limb muscles (gastrocnemius, soleus, tibialis anterior) during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness (i.e., active + passive) at a fixed activation. In three additional trials, the dynamometer will move the ankle joint through the same motion without active subject resistance and the same analytical procedures will derive passive ankle joint stiffness.
OTHER
Gait Biomechanics
Three-dimensional gait analysis is performed as participants walk at a self-selected speed on an instrumented treadmill. Reflective markers are attached to lower extremity segments. Elastic bands are wrapped around the thighs, calves, and pelvis to which small, thermoplastic shells containing reflective markers are attached. Additional markers are taped to the participant's shoes and on the upper back, shoulder, hip, knee, and ankle joints with adhesive skin tape. Marker data is collected using a 7-camera motion analysis system (Vicon Inc., USA). Vicon motion analysis cameras will collect the location of the retroreflective markers in Vicon Nexus software.
OTHER
Gait Biofeedback
Audio-visual biofeedback will be provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map will represent the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target will be provided using the heat map colors of red and target line on the bar graph. For propulsion biofeedback, a visual display with a marker will represent the current propulsion (peak AGRF) and a target provided to modulate propulsion. The plantar pressure and AGRF measurements from the participant's baseline walking trials will be used to determine customized biofeedback targets.
OTHER
Plantar Pressure Biofeedback Gait Training
Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map represents the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target is provided using the heat map colors of red and target line on the bar graph. Participants are informed that the target is a measurement of the pressure under their foot, and their goal is to decrease pressure to achieve their target.
OTHER
Propulsion Biofeedback Gait Training
Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For propulsion biofeedback, a visual display with a marker represents the current propulsion (peak AGRF) and a target provided to modulate propulsion. Participants are informed that the marker is a measurement of how hard they are pushing the ground backward, and their goal is to push-off more to achieve their target.
Primary outcome measures
Biomechanical plantar pressure
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Plantar pressure is calculated in kilopascals (kPa) using a force sensor placed between the participant's foot and insole of their shoe. The peak plantar pressure in regions of interest (forefoot) will be calculated.
Biomechanical Propulsion
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.
Biomechanical modulation of ankle stiffness
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Participants will walk for 3 minutes on a treadmill at their self-selected speed to enable stabilization of movement patterns, warmup, and preconditioning of lower extremity muscles prior to dynamometer tasks. Participants will then be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. Electromyography (EMG) activity will be recorded from lower limb muscles during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness at a fixed activation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- for All Participants:
- 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 Inclusion Criteria for Participants with DPN:
- Diagnosis of DM
- Diagnosis of DPN by a physician
- Foot examination within the past 6 months to document ambulatory status
- Physician's clearance
Exclusion criteria
- for Healthy Able-Bodied Individuals:
- 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 Exclusion Criteria for All Participants:
- History of amputation
- Active ulceration
- Medial column deformity
- 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
- 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
- Individuals who are pregnant, prisoners, or not yet adults
- Inability to communicate with the investigators
- Inability to provide written informed consent
Where
- Pensacola, Florida
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 18, 2026 · Source of record for eligibility and locations