RecruitingNot ApplicableNCT07312032

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

Sponsor

Jason Wilken

Enrollment

20 participants

Start Date

Dec 13, 2025

Study Type

INTERVENTIONAL

Conditions

Trauma Injury

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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
Ability to read and write in English and provide written informed consent
Ability to fit in a generic sized CDO

Exclusion Criteria9

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)
Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
Require use of an assistive device
Unhealed wounds (cuts/abrasions) that would prevent AFO use
BMI \> 40
Pregnancy

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Interventions

DEVICECarbon Fiber Custom Dynamic Orthosis

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.

DEVICECarbon Fiber Footplate

One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness