Recruiting

Biofeedback

Sponsor:

Florida Institute for Human and Machine Cognition

Code:

NCT06591780

Conditions

Diabetic Peripheral Neuropathy

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Clinical Evaluation

Plantar Pressure Biofeedback Gait Training

Propulsion Biofeedback Gait Training

Study Details

Brief 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, 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

Conditions

Diabetic Peripheral Neuropathy

Diabetes Mellitus

Study ID

NCT06591780

Start date

Oct 20, 2025

Status verified date

Mar, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of amputation
  • Active ulceration
  • Medial column deformity
  • 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
  • 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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Real-Time Biofeedback Walking Trials

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.

Interventions

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 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 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

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 measure

  • Biomechanical plantar pressure [ Time Frame: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2) ]
  • Biomechanical Propulsion [ Time Frame: Study Session 2 (occurs 24 hours up to 2 weeks after Session 2) ]

Central Contacts and Locations

Central contacts

Locations

Florida Institute for Human and Machine Cognition

Recruiting

Pensacola, Florida, United States, 32502

Contacts

Nicole K Rendos, PhD

850-202-4442

More Information

Sponsor

Florida Institute for Human and Machine Cognition

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • anterior ground reaction force
  • biofeedback-induced changes in plantar pressure
  • diabetic peripheral neuropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida Institute for Human and Machine Cognition on 2026-03-11.