RECRUITING

Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to collect data to improve gait function in individuals with Diabetic Peripheral Neuropathy (DPN). The primary goals are to evaluate: * Biomechanical mechanisms contributing to abnormal plantar pressure and propulsion during gait in individuals with DPN * Biofeedback-induced changes in plantar pressure, propulsion, and biomechanics during gait in individuals with DPN The participants will be required to complete * Questionnaires * Clinical examination * 3-Dimensional gait analysis on an instrumented treadmill * Visual and auditory biofeedback on the participant's propulsion and plantar pressure metrics provided by a projector screen during walking

Official Title

Innovative Multi-Variable Biofeedback for Improving Gait Performance in Individuals With Diabetic Peripheral Neuropathy

Quick Facts

Study Start:2025-06
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06591780

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to walk 10-meters independently without an assistive device
  2. * Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 6 minutes at a self-selected speed
  3. * Diagnosis of diabetes mellitus
  4. * Diagnosis of diabetic peripheral neuropathy by a physician
  5. * Foot examination within the past 6 months documenting ambulatory status
  6. * Physician clearance
  1. * History of amputation
  2. * Active ulceration
  3. * Medial column deformity
  4. * Severe cognitive impairment (MoCA \< 10)
  5. * Severe visual impairment
  6. * History of Charcot osteoarthropathy
  7. * History of posterior muscle group lengthening
  8. * History of lower extremity joint replacement
  9. * History of lower extremity and/or foot surgery affecting walking mechanics
  10. * Orthopaedic problems of the lower limbs or spine due to other medical conditions (not diabetes or DPN) that limit walking or cause pain during walking
  11. * Improper footwear for walking and community ambulation
  12. * Cardiovascular or medical condition affecting ability to walk safely
  13. * History of unexplained dizziness or fainting in the past 2 months
  14. * Allergy to adhesive tape or rubbing alcohol

Contacts and Locations

Study Contact

Nicole K Rendos, PhD
CONTACT
(404) 202-4442
nrendos@ihmc.org
Craig Tuggle
CONTACT
850-202-4462
ctuggle@ihmc.org

Principal Investigator

Nicole K Rendos, PhD
PRINCIPAL_INVESTIGATOR
Florida Institute for Human and Machine Cognition

Study Locations (Sites)

Florida Institute for Human and Machine Cognition
Pensacola, Florida, 32502
United States

Collaborators and Investigators

Sponsor: Florida Institute for Human and Machine Cognition

  • Nicole K Rendos, PhD, PRINCIPAL_INVESTIGATOR, Florida Institute for Human and Machine Cognition

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06
Study Completion Date2027-12

Study Record Updates

Study Start Date2025-06
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • anterior ground reaction force
  • biofeedback-induced changes in plantar pressure
  • diabetic peripheral neuropathy

Additional Relevant MeSH Terms

  • Diabetic Peripheral Neuropathy
  • Diabetes Mellitus