Diabetic Peripheral NeuropathyNCT05965336
Walking Function in Diabetic Peripheral Neuropathy
A study testing Clinical Evaluation, Evaluation of Passive Ankle Stiffness and Gait Biomechanics in people with Diabetic Peripheral Neuropathy, run by Florida Institute for Human and Machine Cognition at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Clinical Evaluation, Evaluation of Passive Ankle Stiffness and Gait Biomechanics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 join
- 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
- Active ulceration
- Medial column deformity
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida Institute for Human and Machine Cognition
Pensacola, Florida, 32502
Nicole Rendos, PhD, 850-202-4442, nrendos@ihmc.org
About this study
Official title: Walking Function in Individuals With Diabetic Peripheral Neuropathy: Biomechanical Mechanisms and Implications for Clinical Outcomes and Gait Retraining
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.
Read the detailed description
Over 34 million adults in the United States are living with Diabetes Mellitus (DM). Diabetic peripheral neuropathy (DPN) is the most common complication, affecting 50% of individuals with DM. Consequences of DPN include reduced sensation and feedback from the foot and lower limb and increased plantar pressures, predisposing patients to ulcers and lower extremity amputation. Individuals with DPN experience decreased quality of life compared with their healthy and non-neuropathic DM peers, and report problems with mobility, daily activities, pain, and discomfort. Additionally, people with DPN display reduced functional ambulation, step counts, and walking speed. Though increases in physical activity and functional capacity have been associated with improvements in quality of life, DPN poses a unique challenge in mitigating risk while pursuing traditional exercise and walking programs.
Traditional gait training programs used to improve walking function may increase ulceration risk, making these interventions unsuitable if not tailored for people with DPN. The goal of this study is to elucidate the underlying biomechanical mechanisms contributing to the inter-relationships between plantar pressure and propulsion in individuals with DPN, and to examine the safety and feasibility of using real-time biofeedback to modify plantar pressure and propulsion during gait.
The aims of this study are to evaluate (1) biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN; (2) biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN and age-similar controls; and (3) the acceptability, feasibility, safety, and preliminary effects of gait training in individuals with DPN. Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow for the design of more informed and effective gait rehabilitation interventions aimed at preventing deleterious outcomes such as ulceration and amputation that can be tailored to individual patient characteristics.
Able-bodied participants will complete three experimental sessions and participants with DPN will complete a total of seven experimental sessions. Each session will be approximately 2-3 hours in duration.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Clinical Evaluation, Evaluation of Passive Ankle Stiffness, Gait Biomechanics, Gait Biofeedback, Plantar Pressure Biofeedback Gait Training
- Keywords
- Diabetes, Biofeedback-induced changes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical EvaluationOther
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.
Evaluation of Passive Ankle StiffnessOther
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.
Gait BiomechanicsOther
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.
Gait BiofeedbackOther
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.
Plantar Pressure Biofeedback Gait TrainingOther
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.
Propulsion Biofeedback Gait TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Able-Bodied Participants | Active comparator | 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. Receives: Other: Clinical Evaluation; Other: Evaluation of Passive Ankle Stiffness; Other: Gait Biomechanics; Other: Gait Biofeedback |
| Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training | Experimental | 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. Receives: Other: Clinical Evaluation; Other: Evaluation of Passive Ankle Stiffness; Other: Gait Biomechanics; Other: Gait Biofeedback; Other: Plantar Pressure Biofeedback Gait Training; Other: Propulsion Biofeedback Gait Training |
| Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training | Experimental | 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. Receives: Other: Clinical Evaluation; Other: Evaluation of Passive Ankle Stiffness; Other: Gait Biomechanics; Other: Gait Biofeedback; Other: Plantar Pressure Biofeedback Gait Training; Other: Propulsion Biofeedback Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomechanical plantar pressure
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.
Measured: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Biomechanical Propulsion
Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.
Measured: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Biomechanical modulation of ankle stiffness
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.
Measured: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Secondary outcomes (3)
Changes induced by biofeedback in plantar pressure
Plantar pressure measurements will be recorded using insoles placed between the surface of the foot and the insole of the participant's shoe. Marker data, GRFs, and plantar pressure data will be synchronized.
Regression analysis will be used to examine plantar pressure during gait by study group.
Measured: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
Changes induced by biofeedback in propulsion
Ground reaction force (GRF) data will be collected independently from each leg using a split-belt treadmill instrumented with two 6-degree of freedom force platforms. The antero-posterior GRFs (AGRF) will be used to compute propulsion.
Regression analysis will be used to examine propulsion during gait by study group.
Measured: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
Changes induced by biofeedback in biomechanics during gait
Lower extremity kinetics and kinematics will be measured using a three-dimensional motion analysis system and split-belt instrumented treadmill. Kinetics and kinematics of the ankle, knee, and hip will be analyzed during gait.
Measured: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start5 Dec 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- To evaluate biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN versus age-similar controls. Then, participants with DPN will will complete an additional four experimental sessions to collect data in a randomized crossover pilot clinical trial to examine the acceptability, feasibility, safety, and preliminary effects of gait biofeedback training in individuals with DPN.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Institute for Human and Machine Cognition
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nicole Rendos, Florida Institute for Human and Machine Cognition
- Investigators
- Nicole Rendos, PhD, Principal investigator, Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965336
- Sponsor's protocol ID
- IRB-2025-0002
- Other IDs
- K01HD107294
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie published results will be made available for sharing with other researchers after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking Function in Individuals With Diabetic Peripheral Neuropathy: Biomechanical Mechanisms and Implications for Clinical Outcomes and Gait Retraining
- ClinicalTrials.gov ID
- NCT05965336
- Acronym / sponsor ID
- IRB-2025-0002
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetes, Biofeedback-induced changes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Florida Institute for Human and Machine CognitionUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over 34 million adults in the United States are living with Diabetes Mellitus (DM). Diabetic peripheral neuropathy (DPN) is the most common complication, affecting 50% of individuals with DM. Consequences of DPN include reduced sensation and feedback from the foot and lower limb and increased plantar pressures, predisposing patients to ulcers and lower extremity amputation. Individuals with DPN experience decreased quality of life compared with their healthy and non-neuropathic DM peers, and report problems with mobility, daily activities, pain, and discomfort. Additionally, people with DPN display reduced functional ambulation, step counts, and walking speed. Though increases in physical activity and functional capacity have been associated with improvements in quality of life, DPN poses a unique challenge in mitigating risk while pursuing traditional exercise and walking programs.
Traditional gait training programs used to improve walking function may increase ulceration risk, making these interventions unsuitable if not tailored for people with DPN. The goal of this study is to elucidate the underlying biomechanical mechanisms contributing to the inter-relationships between plantar pressure and propulsion in individuals with DPN, and to examine the safety and feasibility of using real-time biofeedback to modify plantar pressure and propulsion during gait.
The aims of this study are to evaluate (1) biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN; (2) biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN and age-similar controls; and (3) the acceptability, feasibility, safety, and preliminary effects of gait training in individuals with DPN. Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow for the design of more informed and effective gait rehabilitation interventions aimed at preventing deleterious outcomes such as ulceration and amputation that can be tailored to individual patient characteristics.
Able-bodied participants will complete three experimental sessions and participants with DPN will complete a total of seven experimental sessions. Each session will be approximately 2-3 hours in duration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- To evaluate biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN versus age-similar controls. Then, participants with DPN will will complete an additional four experimental sessions to collect data in a randomized crossover pilot clinical trial to examine the acceptability, feasibility, safety, and preliminary effects of gait biofeedback training in individuals with DPN.
| Arm | Type | Receives |
|---|---|---|
| Able-Bodied Participants | Active comparator | Other: Clinical Evaluation, Other: Evaluation of Passive Ankle Stiffness, Other: Gait Biomechanics, Other: Gait BiofeedbackAble-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. |
| Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training | Experimental | Other: Clinical Evaluation, Other: Evaluation of Passive Ankle Stiffness, Other: Gait Biomechanics, Other: Gait Biofeedback, Other: Plantar Pressure Biofeedback Gait Training, Other: Propulsion Biofeedback Gait TrainingParticipants 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. |
| Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training | Experimental | Other: Clinical Evaluation, Other: Evaluation of Passive Ankle Stiffness, Other: Gait Biomechanics, Other: Gait Biofeedback, Other: Plantar Pressure Biofeedback Gait Training, Other: Propulsion Biofeedback Gait TrainingParticipants 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
- Active ulceration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical EvaluationA 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 | Able-Bodied Participants, Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training, Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training |
| Evaluation of Passive Ankle StiffnessParticipants 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 | Able-Bodied Participants, Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training, Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training |
| Gait BiomechanicsThree-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 | Able-Bodied Participants, Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training, Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training |
| Gait BiofeedbackAudio-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 | Able-Bodied Participants, Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training, Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training |
| Plantar Pressure Biofeedback Gait TrainingParticipants 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 | Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training, Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training |
| Propulsion Biofeedback Gait TrainingParticipants 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. | Other | Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training, Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training |
Primary outcome
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.
3 secondary outcomes
Changes induced by biofeedback in plantar pressure
Time frame: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
Changes induced by biofeedback in propulsion
Time frame: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
Changes induced by biofeedback in biomechanics during gait
Time frame: Study sessions 4 (48 hours - 3 weeks after session 3), 5 (24-48 hours after session 4) , 6 (3 weeks after session 5) and 7 (24-48 hours after session 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie published results will be made available for sharing with other researchers after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Rendos, PhD principal investigator
Research Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Evaluation, Evaluation of Passive Ankle Stiffness and Gait Biomechanics in people with Diabetic Peripheral Neuropathy, run by Florida Institute for Human and Machine Cognition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Rendos, PhD ((850) 202-4442, nrendos@ihmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomechanical plantar pressure (time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.