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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study session 2 (occurs 24 hours up to 2 weeks after day 1)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biomechanical Propulsion
Biomechanical modulation of ankle stiffness
Biomechanical plantar pressure
Secondary outcome measures
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.
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Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,607 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,747 Total Patients Enrolled
Nicole Rendos, PhDPrincipal InvestigatorAssistant Professor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with diabetic peripheral neuropathy.I have had surgery to lengthen muscles in the back of my leg.I am not pregnant, imprisoned, or under the legal adult age.I can walk on a treadmill for 1 minute at my own pace.I had a foot exam in the last 6 months to check my ability to walk.You cannot talk to the researchers.I can walk 10 meters on my own without help.You are allergic to tape or rubbing alcohol.I have leg or back problems not caused by diabetes that affect my walking.I have had a joint replacement in my leg.I have a history of Charcot joint disease.I have a heart or medical condition that makes walking unsafe.I have had an amputation.I currently have an open sore that is not healing.I have a deformity in the inner part of my foot.I have been diagnosed with diabetes.I have had bone or joint problems in my legs.I have a history of a neurological condition.I have had a leg injury or pain that affects my walking in the last 6 months.I have had surgery on my leg or foot that affects how I walk.I wear shoes that are not suitable for walking or daily activities.I have had unexplained dizziness or fainting recently.I am 45 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Propulsion Biofeedback Gait Training Followed by Plantar Pressure Biofeedback Gait Training
- Group 2: Able-Bodied Participants
- Group 3: Plantar Pressure Biofeedback Gait Training Followed by Propulsion Biofeedback Gait Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollment opportunities currently available for this clinical trial?
"Per the clinicaltrials.gov database, this study is no longer taking on applicants as recruitment closed after its initial post date of September 1st 2023 and last adjustment on July 20th 2023. Despite that fact, there are currently 190 other trials actively recruiting patients."
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