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NCT Number: NCT06127316

The Effects of Heel Distraction Height on Foot Loading With Carbon Fiber Custom Dynamic Orthoses

Carbon fiber custom dynamic orthoses (CDOs) and unloading ankle foot orthoses (AFOs) have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. CDOs and unloading AFOs have shown differing offloading capabilities across different regions of the foots (hindfoot, midfoot, forefoot) which may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate. The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion during gait as well as patient reported 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. 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. Unloading ankle foot orthoses (AFOs) have also been used for a number of lower extremity conditions, including traumatic injuries, in effort to reduce forces and pressure acting under the foot. Unloading AFOs have been created using many different designs, which include a proximal cuff just below the knee, a rigid strut (made of metal, plastic, etc.), and some sort of foot component (footplate, shoe, etc.).

Both CDOs and unloading AFOs have shown varying levels of success in reducing forces acting on different regions of the bottom of the foot during gait. The differences in loading may be related to a distinct difference between CDOs and unloading AFOs: CDOs do not suspend, or distract, the foot away from the footplate.

The purpose of this study is to determine the effects of CDOs and heel distraction height (the distance between the heel and the footplate) on limb loading and motion as well as patient reported pain and comfort. In this study, forces acting under the foot will be measured using wireless Loadsol insoles (Novel GMBH, St. Paul, MN) as participants walk without an orthosis (NoCDO) and with a CDO with three different posterior strut lengths resulting in three different levels of heel distraction (0cm, 1cm, 2cm) at self-selected and controlled speeds. Additionally, gait kinematic and kinetics will be measured using infrared motion capture cameras (Vicon Motion Systems Ltd., Denver, CO) and force plates (AMTI, Watertown, MA). Participants will be provided a lift for the contralateral limb to reduce the effects of leg length discrepancies during walking. Loadpad force measuring sensors (Novel GMBH, St. Paul, MN) will be used to measure forces within the CDO proximal cuff. After walking in each condition, participants will complete questionnaires concerning pain and orthosis comfort.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ages 18-65 years
  • Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)
  • Mechanical pain with limb loading (>=4/10 on Numerical Pain Rating Scale)
  • Ability to walk 50 feet at a slow to moderate pace
  • Ability to walk without a cane or crutch
  • Ability to read and write in English and provide written informed consent

Exclusion criteria

  • Diagnosis with a moderate or severe brain injury
  • Diagnosis with a physical or psychological condition that would preclude functional testing (e.g., cardiac condition, clotting disorder, pulmonary condition, etc.
  • Ankle weakness resulting from spinal cord injury or central nervous system pathology
  • Nerve, muscle, bone, or other condition limiting function in the contralateral extremity
  • Rheumatoid or inflammatory arthritis
  • Necrosis of any bones in the foot or ankle
  • Pain of 8/10 or greater during walking
  • Uncorrected visual or hearing impairments
  • Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)
  • Pregnancy
  • Body mass index greater than 40 kg/m2

Treatment and study plan

Carbon Fiber Custom Dynamic Orthosis (CDO)

Device

The carbon fiber custom dynamic orthoses (CDOs) 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. The CDO will be modular in design which will allow three carbon fiber struts of the same stiffness and differing lengths to be used to implement 0cm, 1cm, and 2cm levels of heel distraction height. A longer posterior strut will move the carbon fiber footplate away from the participants foot to create the heel distraction height.

Other names: Ankle Foot Orthosis (AFO)

Primary outcomes

  1. Peak Force (forefoot)

    Time frame: Baseline

    Plantar forces (N) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.

  2. Force Impulse (forefoot)

    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 as participants walk without a CDO and with each CDO.

  3. Peak Force (hindfoot)

    Time frame: Baseline

    Plantar forces (N) will be measured across the hindfoot (proximal 30% sensor) as participants walk without a CDO and with each CDO.

  4. Force Impulse (hindfoot)

    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 as participants walk without a CDO and with each CDO.

  5. 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

  6. Modified Socket Comfort Score

    Time frame: Baseline

    Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth

Secondary outcomes

  1. Peak Force (total foot)

    Time frame: Baseline

    Plantar forces (N) will be measured across the total foot (100% of sensors) as participants walk without a CDO and with each CDO.

  2. Force Impulse (total foot)

    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 as participants walk without a CDO and with each CDO.

  3. Peak Force (midfoot)

    Time frame: Baseline

    Plantar forces (N) will be measured across the midfoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.

  4. Force Impulse (midfoot)

    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 as participants walk without a CDO and with each CDO.

  5. Ankle Range of Motion

    Time frame: Baseline

    Peak ankle dorsiflexion (degrees) during gait.

  6. Peak Ankle Moment

    Time frame: Baseline

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

  7. Peak Ankle Power

    Time frame: Baseline

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

Other outcomes

  1. Semi-Structured Interview

    Time frame: Baseline

    Participants will be asked a number of open ended questions to help determine what factors influenced their perception of each study condition.

Study contacts

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

Jason M Wilken, PT, PhD

CONTACT

[email protected]

3193356857

Kirsten M Anderson, PhD

CONTACT

[email protected]

3193530431

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • Fabtech Systems

Registry information

Acronym: CDODistract

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Jan 15, 2026

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.