Clinical trial NCT05965336: Walking Function in Diabetic Peripheral Neuropathy
Official title: Walking Function in Individuals With Diabetic Peripheral Neuropathy: Biomechanical Mechanisms and Implications for Clinical Outcomes and Gait Retraining
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetes
Biofeedback-induced changes
Lead sponsor: Florida Institute for Human and Machine Cognition
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-07-28
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Biomechanical plantar pressure
timeFrame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
measure: Biomechanical Propulsion
timeFrame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
measure: Biomechanical modulation of ankle stiffness
timeFrame: Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
Secondary outcomes:
measure: Changes induced by biofeedback in plantar pressure
timeFrame: 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)
measure: Changes induced by biofeedback in propulsion
timeFrame: 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)
measure: Changes induced by biofeedback in biomechanics during gait
timeFrame: 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)
Other outcomes:
Locations:
city: Pensacola
country: United States
facility: Florida Institute for Human and Machine Cognition
state: Florida
Study officials:
affiliation: Research Scientist
name: Nicole Rendos, PhD
role: PRINCIPAL_INVESTIGATOR
References: