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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-90
SponsorFlorida Institute for Human and Machine Cognition

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able to walk 10-meters independently without an assistive device

Sufficient cardiovascular and musculoskeletal health to walk on a treadmill for 6 minutes at a self-selected speed

Diagnosis of diabetes mellitus

Diagnosis of diabetic peripheral neuropathy by a physician

Disqualifiers

History of amputation

Active ulceration

Medial column deformity

Severe cognitive impairment (MoCA < 10)

Trial design

Design model

Single group

Treatments tested in this trial

  • Clinical Evaluation

    Other intervention

    A clinical evaluation occurs at the first study session. The clinical evaluation assesses walking function and mobility, lower extremity, sensation, health-related quality of life (HRQoL) and foot function. Session 2 will be a dynamometer-based evaluation of passive ankle stiffness and a 3-dimensional gait analysis to evaluate baseline biomechanics. During Session 3, real-time biofeedback conditions will be used to measure the immediate effects on walking function.

  • Plantar Pressure Biofeedback Gait Training

    Other intervention

    Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant's immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For plantar pressure biofeedback, a visual display of a foot with a colored heat map represents the current plantar pressure, in addition to bar graphs representing real-time movement of plantar pressure in specific areas of the foot. A target is provided using the heat map colors of red and target line on the bar graph. Participants are informed that the target is a measurement of the pressure under their foot, and their goal is to decrease pressure to achieve their target

  • Propulsion Biofeedback Gait Training

    Other intervention

    Participants will complete a 3-dimensional gait evaluation prior to training, after a 6-minute control bout without biofeedback, and following three 6-minute biofeedback training bouts (total 18-minutes). Individualized biofeedback targets will be calculated from each participant\'s immediate biofeedback session to best minimize plantar pressure whilst maintaining or enhancing propulsion. Audio-visual biofeedback is provided using a screen placed in front of the treadmill and a speaker. For propulsion biofeedback, a visual display with a marker represents the current propulsion (peak AGRF) and a target provided to modulate propulsion. Participants are informed that the marker is a measurement of how hard they are pushing the ground backward, and their goal is to push-off more to achieve their target.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Real-Time Biofeedback Walking TrialsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Biomechanical plantar pressure

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.

Time frame
Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)
2

Biomechanical Propulsion

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

Time frame
Study Session 2 (occurs 24 hours up to 2 weeks after Session 2)

Secondary outcomes

1

Changes induced by biofeedback in plantar pressure

Plantar pressure measurements will be recorded using insoles placed between the surface of the foot and the insole of the participant's shoe. Marker data, GRFs, and plantar pressure data will be synchronized.

Time frame
Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
2

Changes induced by biofeedback in propulsion

Ground reaction force (GRF) data will be collected independently from each leg using a split-belt treadmill instrumented with two 6-degree of freedom force platforms. The antero-posterior GRFs (AGRF) will be used to compute propulsion.

Time frame
Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)
3

Changes induced by biofeedback in biomechanics during gait

Lower extremity kinetics and kinematics will be measured using a three-dimensional motion analysis system and split-belt instrumented treadmill. Kinetics and kinematics of the ankle, knee, and hip will be analyzed during gait.

Time frame
Study Session 3 (occurs 24 hours up to 2 weeks after Session 3)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida Institute for Human and Machine Cognition

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator