Walking Function in Diabetic Peripheral Neuropathy

NCT05965336 | Recruiting

• 2 other identifiers: IRB-2025-0002K01HD107294
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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, safety, and preliminary effects of walking training with feedback on walking function in individuals with diabetic peripheral neuropathy.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetes; Biofeedback-induced changes

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)

Secondary Outcomes (3)

• Changes induced by biofeedback in plantar pressure

  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

  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

  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)

Study Arms (3)

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.

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.

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.

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

Interventions

Clinical Evaluation OTHER

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.

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 Stiffness OTHER

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.

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 Biomechanics OTHER

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.

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 Biofeedback OTHER

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.

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 Training OTHER

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.

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 Training OTHER

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.

Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training; Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Florida Institute for Human and Machine Cognition: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Florida Institute for Human and Machine Cognition

Pensacola, Florida, 32502, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nicole Rendos, PhD

  Research Scientist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Rendos, PhD

CONTACT

(850) 202-4442; nrendos@ihmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: December 5, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 12 months and ending 36 months following publication of the the findings from this study.
• Access Criteria: Data will be available to be shared with scientific and clinical collaborators, clinical and research communities, for individual participant data meta-analyses. Requests should be directed to nrendos@emory.edu and may be submitted up to 36 months following publication of this study. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)