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Behavioural Intervention

Biofeedback Gait Training for Diabetic Peripheral Neuropathy

N/A

Recruiting

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 DPN by a physician

Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 1-minute at self-selected speed

Must not have

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

History of posterior muscle group lengthening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study session 2 (occurs 24 hours up to 2 weeks after day 1)

Awards & highlights

Summary

This trial looks at how feedback on walking form can help improve walking function in people with diabetic peripheral neuropathy.

Who is the study for?

This trial is for adults aged 45 and older with diabetic peripheral neuropathy (DPN) who can walk independently without aids. Participants must have a diabetes diagnosis, be able to walk on a treadmill, and have had a foot exam in the last six months. People with certain lower limb conditions, surgeries affecting walking, cardiovascular issues that impact safety while walking, or those pregnant cannot join.

What is being tested?

The study aims to compare walking function between individuals with DPN and healthy adults. It will test if gait training with biofeedback improves walking patterns in people with DPN. The trial includes clinical evaluations of movement and stiffness as well as specialized gait training sessions.

What are the potential side effects?

Since this trial involves non-drug interventions like gait training and biomechanical feedback rather than medication, side effects may include muscle soreness or fatigue from physical activity. There's also a small risk of falls or injuries related to treadmill use.

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 diabetic peripheral neuropathy.

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I can walk on a treadmill for 1 minute at my own pace.

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I can walk 10 meters on my own without help.

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I have been diagnosed with diabetes.

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I am 45 years old or older.

Exclusion Criteria

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

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

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

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I am not pregnant, imprisoned, or under the legal adult age.

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I have had a joint replacement in my leg.

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I have a history of Charcot joint disease.

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

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I have had an amputation.

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I currently have an open sore that is not healing.

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

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I have had bone or joint problems in my legs.

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

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study session 2 (occurs 24 hours up to 2 weeks after day 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study session 2 (occurs 24 hours up to 2 weeks after day 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and study session 2 (occurs 24 hours up to 2 weeks after day 1) 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 modulation of ankle stiffness

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait TrainingExperimental Treatment6 Interventions

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.

Group II: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait TrainingExperimental Treatment6 Interventions

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.

Group III: Able-Bodied ParticipantsActive Control4 Interventions

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.

0 / 18Eligibility criteria met

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Who is running the clinical trial?

Emory UniversityLead Sponsor

1,679 Previous Clinical Trials

2,583,616 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

2,014 Previous Clinical Trials

2,696,784 Total Patients Enrolled

Nicole Rendos, PhDPrincipal InvestigatorAssistant Professor

Media Library

Gait Biofeedback (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05965336 — N/A

Diabetic Neuropathy Research Study Groups: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training, Able-Bodied Participants, Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training

Diabetic Neuropathy Clinical Trial 2023: Gait Biofeedback Highlights & Side Effects. Trial Name: NCT05965336 — N/A

Gait Biofeedback (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05965336 — N/A

~33 spots leftby Mar 2027

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