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Behavioural Intervention

Biofeedback Gait Training for Diabetic Neuropathy

N/A

Waitlist Available

Led By Nicole Rendos, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of diabetes mellitus

Diagnosis of diabetic peripheral neuropathy by a physician

Must not have

Severe visual impairment

Active ulceration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study session 3 (occurs 24 hours up to 2 weeks after session 3)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how to improve walking function in people with Diabetic Peripheral Neuropathy. They will look at the reasons behind abnormal foot pressure and walking difficulties in these individuals. Participants will undergo

Who is the study for?

This trial is for individuals with Diabetic Peripheral Neuropathy, which can lead to foot problems like ulcers. Participants should be able to complete questionnaires, undergo a clinical exam, and perform gait analysis on a treadmill. Specific inclusion and exclusion criteria details are not provided.

What is being tested?

The study tests how biofeedback training affects walking in people with diabetic nerve damage in their feet. It uses visual and auditory cues to help improve plantar pressure (how the foot presses on the ground) and propulsion (how the foot pushes off).

What are the potential side effects?

Since this trial involves non-invasive biofeedback training rather than medication or surgery, side effects may include fatigue from physical activity or discomfort from standing or walking during assessments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with diabetes.

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I have been diagnosed with diabetic nerve pain by a doctor.

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I can walk 10 meters on my own without help.

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I can walk on a treadmill for 6 minutes at my own pace.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe difficulty seeing.

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I currently have an open sore that is not healing.

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I have a heart or medical condition that makes walking unsafe.

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I have had a hip or knee replacement.

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I have had an amputation.

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I have had surgery on my leg or foot that affects how I walk.

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I have a deformity in the middle part of my foot.

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I have had surgery to lengthen muscles in the back of my body.

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I have leg or spine problems not caused by diabetes that affect my walking.

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I wear shoes that are not suitable for walking or daily activities.

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I have had unexplained dizziness or fainting recently.

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I have a history of Charcot joint disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study session 2 (occurs 24 hours up to 2 weeks after session 2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study session 2 (occurs 24 hours up to 2 weeks after session 2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and study session 2 (occurs 24 hours up to 2 weeks after session 2) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biomechanical Propulsion

Biomechanical plantar pressure

Secondary study objectives

Changes induced by biofeedback in biomechanics during gait

Changes induced by biofeedback in plantar pressure

Changes induced by biofeedback in propulsion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Real-Time Biofeedback Walking TrialsExperimental Treatment3 Interventions

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.

0 / 16Eligibility criteria met