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NCT Number: NCT07312032

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ankle foot orthosis

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

Primary outcomes

  1. Peak Forefoot Force

    Time frame: Baseline

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

  2. 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.

  3. Peak Hindfoot Force

    Time frame: Baseline

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

  4. 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.

  5. Peak Ankle Power

    Time frame: Baseline

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

Secondary outcomes

  1. Peak Midfoot Force

    Time frame: Baseline

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

  2. 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.

  3. Peak Total Foot Force

    Time frame: Baseline

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

  4. 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.

  5. Peak Ankle Dorsiflexion

    Time frame: Baseline

    Peak ankle dorsiflexion (degrees) during gait.

  6. Peak Ankle Plantarflexion

    Time frame: Baseline

    Peak ankle plantarflexion (degrees) during gait.

  7. Ankle Range of Motion

    Time frame: Baseline

    Range of ankle motion (degrees) during gait.

  8. Peak Ankle Dorsiflexion Moment

    Time frame: Baseline

    Peak ankle dorsiflexion moment (Nm/kg) during gait.

  9. Peak Ankle Plantarflexion Moment

    Time frame: Baseline

    Peak ankle plantarflexion moment (Nm/kg) during gait.

  10. 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

  11. Modified Socket Comfort Score (Comfort)

    Time frame: Baseline

    Comfort scores range from 0 = most uncomfortable to 10= most comfortable

Other outcomes

  1. Modified Socket Comfort Score (Smoothness)

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jason M Wilken, PT, PhD

CONTACT

[email protected]

+1 319 3356857

Kirsten M Anderson, PhD

CONTACT

[email protected]

3193530431

Sponsors and collaborators

Lead sponsor

Jason Wilken

Other

Collaborators

  • University of Iowa

Registry information

Acronym: CDOCFPlate

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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