Walking Function in Diabetic Peripheral Neuropathy

State University System of Florida

Status: Suspended

Conditions: Diabetic Peripheral Neuropathy

Treatments: Other: Gait Biomechanics; Other: Gait Biofeedback; Other: Evaluation of Passive Ankle Stiffness; Other: Plantar Pressure Biofeedback Gait Training; Other: Clinical Evaluation; Other: Propulsion Biofeedback Gait Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05965336

IRB-2025-0002

K01HD107294 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for All Participants:

1. Age 45+ years
2. Able to walk 10-meters independently without an assistive device
3. Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 1-minute at self-selected speed

Inclusion Criteria for Participants with DPN:

1. Diagnosis of DM
2. Diagnosis of DPN by a physician
3. Foot examination within the past 6 months to document ambulatory status
4. Physician's clearance

Exclusion Criteria for Healthy Able-Bodied Individuals:

1. History of neurologic disease
2. History of orthopaedic disease affecting the lower extremities
3. History of injury or pain affecting the lower extremity or walking function within the past 6 months

Exclusion Criteria for All Participants:

1. History of amputation
2. Active ulceration
3. Medial column deformity
4. History of Charcot osteoarthropathy
5. History of posterior muscle group lengthening
6. History of lower extremity joint replacement
7. History of lower extremity and/or foot surgery affecting walking mechanics
8. 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
9. Improper footwear for walking and community ambulation
10. Cardiovascular or medical condition affecting ability to walk safely
11. History of unexplained dizziness or fainting in the past 2 months
12. Allergy to adhesive tape or rubbing alcohol
13. Individuals who are pregnant, prisoners, or not yet adults
14. Inability to communicate with the investigators
15. Inability to provide written informed consent

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Able-Bodied Participants

Active Comparator group

Description:

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.

Treatment:

Other: Clinical Evaluation

Other: Gait Biofeedback

Other: Evaluation of Passive Ankle Stiffness

Other: Gait Biomechanics

Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training

Experimental group

Description:

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.

Treatment:

Other: Propulsion Biofeedback Gait Training

Other: Clinical Evaluation

Other: Plantar Pressure Biofeedback Gait Training

Other: Gait Biofeedback

Other: Evaluation of Passive Ankle Stiffness

Other: Gait Biomechanics

Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training

Experimental group

Description:

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.

Treatment:

Other: Propulsion Biofeedback Gait Training

Other: Clinical Evaluation

Other: Plantar Pressure Biofeedback Gait Training

Other: Gait Biofeedback

Other: Evaluation of Passive Ankle Stiffness

Other: Gait Biomechanics