The Effects of Footplate Stiffness on Foot Loading Within Carbon Fiber Custom Dynamic Orthoses

ConditionTrauma Injury

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorJason Wilken

About this trial

Carbon fiber custom dynamic orthoses (CDOs) improve function, reduce pain, and offload the foot and ankle. CDOs include a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that bends to store and return energy, and a semi-rigid carbon fiber footplate. The purpose of this study is to determine the effect of CDO use and CDO footplate stiffness on foot loading, limb mechanics, pain, and comfort.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Between the ages of 18 and 65

Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months

Able to hop without pain

Able to perform a full squat without pain

Disqualifiers

Diagnosed with a moderate or severe brain injury

Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks

Injuries that would limit performance in this study

Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition)

Trial design

Design model

Crossover

Treatments tested in this trial

Carbon Fiber Custom Dynamic Orthosis
Device
The carbon fiber custom dynamic orthosis (CDO) used in this study will consist of a semi-rigid carbon fiber footplate, a carbon fiber posterior strut, and a proximal cuff that wraps around the leg below the knee.
Carbon Fiber Footplate
Device
One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness

Treatment groups

20 Participants

are divided into 4 treatment groups

Group A: NoCDONo intervention 0 interventions

Group B: CDOExperimental treatment 1 intervention

Group C: 1CFPlateExperimental treatment 2 interventions

Group D: 2CFPlateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Peak Forefoot Force

Plantar forces (N) will be measured across the forefoot (distal 40% of sensor).

Time frame

Baseline

Forefoot Force Impulse

Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase.

Time frame

Baseline

Peak Hindfoot Force

Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor).

Time frame

Baseline

Hindfoot Force Impulse

Plantar force impulse (Ns) across the hindfoot (proximal 30% sensor) will be calculated using the integral of the force over the stance phase.

Time frame

Baseline

Secondary outcomes

Peak Midfoot Force

Plantar forces (N) will be measured across the midfoot (middle 30% of sensor).

Time frame

Baseline

Midfoot Force Impulse

Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase.

Time frame

Baseline

Peak Total Foot Force

Plantar forces (N) will be measured across the total foot (100% of sensors).

Time frame

Baseline

Total Foot Force Impulse

Plantar force impulse (Ns) across the total foot (100% of sensors) will be calculated using the integral of the force over the stance phase.

Time frame

Baseline

Other outcomes

Modified Socket Comfort Score (Smoothness)

Smoothness scores range from 0 = least smooth to 10 = most smooth

Time frame

Baseline

Sponsors and contacts

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

Jason Wilken

Lead sponsor

University of Iowa

Sponsor institution

University of Iowa

Collaborator

Source ClinicalTrials.gov

Apply now