Diabetic Peripheral NeuropathyNCT06591780
Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
A study testing Clinical Evaluation, Plantar Pressure Biofeedback Gait Training and Propulsion Biofeedback Gait Training in people with Diabetic Peripheral Neuropathy and Diabetes Mellitus, run by Florida Institute for Human and Machine Cognition at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Diabetes Mellitus
- What is being tested?
- Clinical Evaluation, Plantar Pressure Biofeedback Gait Training and Propulsion Biofeedback Gait Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to 1 Jun 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- History of amputation
- Active ulceration
- Medial column deformity
- Severe cognitive impairment (MoCA \< 10)
- Severe visual impairment
- History of Charcot osteoarthropathy
Show all 14Show fewer
- 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
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 K Rendos, PhD, 850-202-4442
About this study
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
Read the detailed description
Over 38 million adults in the United States (~1 in 7) are living with Diabetes Mellitus (DM), of which diabetic peripheral neuropathy (DPN) is the most common complication, affecting more than 50% of individuals with DM. DPN causes both sensory and motor impairments of the foot and ankle, leading to reduced functional mobility and increased ulceration and amputation risk. Propulsion and plantar pressure are two key interrelated gait parameters contributing to walking function and ulceration risk, respectively. Real-time biofeedback is a non-invasive rehabilitation strategy with significant promise for targeting gait impairments by providing the user with quantitative information regarding a targeted performance variable.
In this study, the team will evaluate multi-joint lower extremity biomechanical responses to univariate propulsion and plantar pressure biofeedback. Secondly, the team will use identified biomechanical compensations to propulsion and plantar pressure biofeedback to develop a multi-variable, implicit, individualized visual biofeedback program to improve gait function in individuals with DPN. Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow us to design 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.
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes Mellitus
- Being tested
- Clinical Evaluation, Plantar Pressure Biofeedback Gait Training, Propulsion Biofeedback Gait Training
- Keywords
- anterior ground reaction force, biofeedback-induced changes in plantar pressure, diabetic peripheral neuropathy
- 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 a 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.
Plantar Pressure Biofeedback Gait TrainingOther
Also called Intervention A
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
Also called Intervention B
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 |
|---|---|---|
| Real-Time Biofeedback Walking Trials | Experimental | 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. Receives: Other: Clinical Evaluation; 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 Session 2)
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 Session 2)
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.
Measured: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
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.
Measured: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
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 Session 3 (occurs 24 hours up to 2 weeks after Session 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Oct 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Institute for Human and Machine Cognition
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Rendos, Florida Institute for Human and Machine Cognition
- Investigators
- Nicole K Rendos, PhD, Principal investigator, Florida Institute for Human and Machine Cognition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591780
- Sponsor's protocol ID
- IRB-2025-0002.1
- Other IDs
- P30DK111024
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on demographics, medical history, clinical evaluation, questionnaires, walking biomechanics, and plantar pressure data will be collected from individuals (N = 25) with diabetic peripheral neuropathy. Subject-level de-identified data will be preserved and shared in raw and pre-processed forms in ".csv" and ".xlsx" format. Biomechanics data will be processed and saved in ".c3d" formatted files as per standard practice in the field of biomechanics.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06591780
- Acronym / sponsor ID
- IRB-2025-0002.1
- Conditions
- Diabetic Peripheral Neuropathy, Diabetes Mellitus
- Keywords
- anterior ground reaction force, biofeedback-induced changes in plantar pressure, diabetic peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Florida Institute for Human and Machine CognitionUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 19 Sep 2024 (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.
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
Detailed description
Over 38 million adults in the United States (~1 in 7) are living with Diabetes Mellitus (DM), of which diabetic peripheral neuropathy (DPN) is the most common complication, affecting more than 50% of individuals with DM. DPN causes both sensory and motor impairments of the foot and ankle, leading to reduced functional mobility and increased ulceration and amputation risk. Propulsion and plantar pressure are two key interrelated gait parameters contributing to walking function and ulceration risk, respectively. Real-time biofeedback is a non-invasive rehabilitation strategy with significant promise for targeting gait impairments by providing the user with quantitative information regarding a targeted performance variable.
In this study, the team will evaluate multi-joint lower extremity biomechanical responses to univariate propulsion and plantar pressure biofeedback. Secondly, the team will use identified biomechanical compensations to propulsion and plantar pressure biofeedback to develop a multi-variable, implicit, individualized visual biofeedback program to improve gait function in individuals with DPN. Insights into the biomechanical mechanisms underlying plantar pressure and propulsion in people with DPN will allow us to design 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-Time Biofeedback Walking Trials | Experimental | Other: Clinical Evaluation, Other: Plantar Pressure Biofeedback Gait Training, Other: Propulsion Biofeedback Gait TrainingReal-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. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- History of amputation
- Active ulceration
- Medial column deformity
- Severe cognitive impairment (MoCA \< 10)
- Severe visual impairment
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 a 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 | Real-Time Biofeedback Walking Trials |
| Plantar Pressure Biofeedback Gait TrainingAlso: Intervention AParticipants 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 | Real-Time Biofeedback Walking Trials |
| Propulsion Biofeedback Gait TrainingAlso: Intervention BParticipants 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 | Real-Time Biofeedback Walking Trials |
Primary outcome
Biomechanical plantar pressure
Time frame: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)
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 Session 2)
Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.
3 secondary outcomes
Changes induced by biofeedback in plantar pressure
Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
Changes induced by biofeedback in propulsion
Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
Changes induced by biofeedback in biomechanics during gait
Time frame: Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
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 11 Mar 2026.
- Individual participant dataSharing planned: Yes. Data on demographics, medical history, clinical evaluation, questionnaires, walking biomechanics, and plantar pressure data will be collected from individuals (N = 25) with diabetic peripheral neuropathy. Subject-level de-identified data will be preserved and shared in raw and pre-processed forms in ".csv" and ".xlsx" format. Biomechanics data will be processed and saved in ".c3d" formatted files as per standard practice in the field of biomechanics.
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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 K Rendos, PhD principal investigator
Florida Institute for Human and Machine Cognition
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, Plantar Pressure Biofeedback Gait Training and Propulsion Biofeedback Gait Training in people with Diabetic Peripheral Neuropathy and Diabetes Mellitus, 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 6 inclusion and 14 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 11 Mar 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 K Rendos, PhD ((404) 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 Session 2)). The study lists 2 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 11 Mar 2026.