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

December 29, 2025 updated by: Jason Wilken
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: NoCDO
Participants will complete study activities without a CDO
Experimental: CDO
Participants will complete study activities while wearing a CDO with standard footplate stiffness
Device: Carbon 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.
Other Names:
  • ankle foot orthosis
Experimental: 1CFPlate
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
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.
Other Names:
  • ankle foot orthosis
Device: Carbon Fiber Footplate
One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness
Experimental: 2CFPlate
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
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.
Other Names:
  • ankle foot orthosis
Device: Carbon Fiber Footplate
One or two additional full-length carbon fiber footplates will be placed under the CDO footplate to increase the effective footplate stiffness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Forefoot Force
Time Frame: Baseline
Plantar forces (N) will be measured across the forefoot (distal 40% of sensor).
Baseline
Forefoot Force Impulse
Time Frame: Baseline
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
Time Frame: Baseline
Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor).
Baseline
Hindfoot Force Impulse
Time Frame: Baseline
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
Time Frame: Baseline
Peak sagittal plane ankle push-off power (W/kg) during gait.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Pain Rating Scale
Time Frame: Baseline
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable
Baseline
Peak Midfoot Force
Time Frame: Baseline
Plantar forces (N) will be measured across the midfoot (middle 30% of sensor).
Baseline
Midfoot Force Impulse
Time Frame: Baseline
Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase.
Baseline
Peak Total Foot Force
Time Frame: Baseline
Plantar forces (N) will be measured across the total foot (100% of sensors).
Baseline
Total Foot Force Impulse
Time Frame: Baseline
Plantar force impulse (Ns) across the total foot (100% of sensors) will be calculated using the integral of the force over the stance phase.
Baseline
Peak Ankle Dorsiflexion
Time Frame: Baseline
Peak ankle dorsiflexion (degrees) during gait.
Baseline
Peak Ankle Plantarflexion
Time Frame: Baseline
Peak ankle plantarflexion (degrees) during gait.
Baseline
Ankle Range of Motion
Time Frame: Baseline
Range of ankle motion (degrees) during gait.
Baseline
Peak Ankle Dorsiflexion Moment
Time Frame: Baseline
Peak ankle dorsiflexion moment (Nm/kg) during gait.
Baseline
Peak Ankle Plantarflexion Moment
Time Frame: Baseline
Peak ankle plantarflexion moment (Nm/kg) during gait.
Baseline
Modified Socket Comfort Score (Comfort)
Time Frame: Baseline
Comfort scores range from 0 = most uncomfortable to 10= most comfortable
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Socket Comfort Score (Smoothness)
Time Frame: Baseline
Smoothness scores range from 0 = least smooth to 10 = most smooth
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jason Wilken

Collaborators

University of Iowa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

December 31, 2025

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202507360 (Other Identifier: University of Iowa)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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