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

Jason Wilken

Status: Enrolling

Conditions: Trauma Injury

Treatments: Device: Carbon Fiber Custom Dynamic Orthosis; Device: Carbon Fiber Footplate

Study type: Interventional

Funder types: Other

Identifiers

NCT07312032

202507360 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Carbon fiber custom dynamic orthoses (CDOs) have been used to improve function, reduce pain, and offload the foot and ankle for individuals with a number of conditions affecting the lower extremity.[1-3] CDOs consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that bends to store and return energy during mid to late stance, a semi-rigid carbon fiber footplate, and, in some cases, a foam heel wedge placed in the shoe. Studies have previously investigated the effects of design characteristics on gait biomechanics and foot loading, however, the effect of foot plate stiffness on resulting foot loading is unknown.

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. In this study, forces acting under the foot will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) and limb mechanics will be measured using motion capture cameras and force plates as participants walk without an orthosis (NoCDO), with a CDO, and with a CDO plus added carbon fiber stiffening inserts (1/2) at a controlled walking speed. Participants will be provided a heel lift for the contralateral limb to prevent leg length discrepancies during walking if necessary. After walking in each condition, participants will complete questionnaires concerning pain and orthosis comfort.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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 Criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 4 patient groups

NoCDO

No Intervention group

Description:

Participants will complete study activities without a CDO

CDO

Experimental group

Description:

Participants will complete study activities while wearing a CDO with standard footplate stiffness

Treatment:

Device: Carbon Fiber Custom Dynamic Orthosis

1CFPlate

Experimental group

Description:

Participants will complete study activities while wearing a CDO with standard footplate stiffness and one additional carbon fiber footplate to increase footplate stiffness

Treatment:

Device: Carbon Fiber Footplate

Device: Carbon Fiber Custom Dynamic Orthosis

2CFPlate

Experimental group

Description:

Participants will complete study activities while wearing a CDO with standard footplate stiffness and two additional carbon fiber footplates to increase footplate stiffness

Treatment:

Device: Carbon Fiber Footplate

Device: Carbon Fiber Custom Dynamic Orthosis