Walking Function in Diabetic Peripheral Neuropathy

This study is looking at how people with diabetic peripheral neuropathy (DPN) walk differently compared to healthy adults. Researchers want to see if providing feedback on walking form can help change walking patterns and if this type of training is safe and effective. You may be able to join if you are 45 or older, can walk 10 meters without help, and have been diagnosed with DPN and diabetes. The study will measure changes in how your foot pushes off the ground and how stiff your ankle is after training. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 50 participants. It will compare walking function and movement patterns between individuals with diabetic peripheral neuropathy and healthy adults.
What's involved
You will have a clinical evaluation at the first session, followed by a second session (24 hours to 2 weeks later) involving evaluations of ankle stiffness, gait biomechanics, and gait training with biofeedback.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for this study are taken at Study Session 2, which occurs 24 hours up to 2 weeks after Day 1.

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NCT05965336

Walking Function in Diabetic Peripheral Neuropathy

Recruiting
NAAges 45+InterventionalBasic science
Florida Institute for Human and Machine Cognition
~50 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Clinical EvaluationEvaluation of Passive Ankle StiffnessGait BiomechanicsGait BiofeedbackPlantar Pressure Biofeedback Gait TrainingPropulsion Biofeedback Gait Training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biomechanical plantar pressure
Measured over Study Session 2 (occurs 24 hours up to 2 weeks after Day 1)
+2 more outcomes measured
Diabetic Peripheral Neuropathy
1 sites across 1 states
Florida1
  • Nicole Rendos, PhD · PRINCIPAL_INVESTIGATOR · Research Scientist

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  • Biomechanical plantar pressureStudy Session 2 (occurs 24 hours up to 2 weeks after Day 1)

    Plantar pressure is calculated in kilopascals (kPa) using a force sensor placed between the participant's foot and insole of their shoe. The peak plantar pressure in regions of interest (forefoot) will be calculated.

  • Biomechanical PropulsionStudy Session 2 (occurs 24 hours up to 2 weeks after Day 1)

    Propulsion is calculated as the maximum anteriorly directed ground reaction force during the stance phase of gait using the instrumented (force plate) treadmill.

  • Biomechanical modulation of ankle stiffnessStudy Session 2 (occurs 24 hours up to 2 weeks after Day 1)

    Participants will walk for 3 minutes on a treadmill at their self-selected speed to enable stabilization of movement patterns, warmup, and preconditioning of lower extremity muscles prior to dynamometer tasks. Participants will then be seated in a dynamometer with their trunk and thigh stabilized to the dynamometer chair, ankle joint aligned with the rotational axis of the dynamometer, and foot stabilized to the foot plate. Electromyography (EMG) activity will be recorded from lower limb muscles during all isolated contractions. Participants will first perform three maximum voluntary isometric contractions (MVIC) while seated in a dynamometer. Participants will then perform three isokinetic dorsiflexion tasks while using electromyographic biofeedback at a prescribed level of 50% MVIC soleus activation. The slope of the linear best fit line from the ankle moment vs. angle plot will yield total ankle joint stiffness at a fixed activation.