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

NCT07312032 | Recruiting FDA Device

• 1 other identifier: 202507360
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trauma Injury

Keywords

carbon fiber; traumatic injury; ankle foot orthosis

Outcome Measures

Primary Outcomes (5)

• Peak Forefoot Force

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

  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.

  Baseline

• Peak Hindfoot Force

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

  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.

  Baseline

• Peak Ankle Power

  Peak sagittal plane ankle push-off power (W/kg) during gait.

  Baseline

Secondary Outcomes (11)

• Peak Midfoot Force

  Baseline

• Midfoot Force Impulse

  Baseline

• Peak Total Foot Force

  Baseline

• Total Foot Force Impulse

  Baseline

• Peak Ankle Dorsiflexion

  Baseline

Other Outcomes (1)

• Modified Socket Comfort Score (Smoothness)

  Baseline

Study Arms (4)

NoCDO

NO INTERVENTION

Participants will complete study activities without a CDO

CDO

EXPERIMENTAL

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

Device: Carbon Fiber Custom Dynamic Orthosis

1CFPlate

EXPERIMENTAL

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

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

2CFPlate

EXPERIMENTAL

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

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

Interventions

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.

Also known as: ankle foot orthosis

1CFPlate; 2CFPlate; CDO

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

1CFPlate; 2CFPlate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jason Wilken: lead
• University of Iowa: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52241, United States

RECRUITING

MeSH Terms

Conditions

Accidental Injuries; Wounds and Injuries

Central Study Contacts

Jason M Wilken, PT, PhD

CONTACT

+1 319 3356857; jason-wilken@uiowa.edu

Kirsten M Anderson, PhD

CONTACT

3193530431; kirsten-m-anderson@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: In this study participants will walk without an orthosis (NoCDO) and with a generic sized CDO with three different levels of footplate stiffness at a controlled speed (CDO, 1CFPlate, 2CFPlate). Testing order of the CDO conditions will be randomized to prevent influence of testing order.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: December 31, 2025
• Study Start: December 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)