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

Last updated: August 26, 2024
Sponsor: University of Iowa
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Carbon Fiber Custom Dynamic Orthosis (CDO)

Clinical Study ID

NCT06127316
202302397
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Ages 18-65 years

  2. Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot orankle)

  3. Mechanical pain with limb loading (>=4/10 on Numerical Pain Rating Scale)

  4. Ability to walk 50 feet at a slow to moderate pace

  5. Ability to walk without a cane or crutch

  6. Ability to read and write in English and provide written informed consent

Exclusion

Exclusion Criteria:

  1. Diagnosis with a moderate or severe brain injury

  2. Diagnosis with a physical or psychological condition that would preclude functionaltesting (e.g., cardiac condition, clotting disorder, pulmonary condition, etc.

  3. Ankle weakness resulting from spinal cord injury or central nervous system pathology

  4. Nerve, muscle, bone, or other condition limiting function in the contralateralextremity

  5. Rheumatoid or inflammatory arthritis

  6. Necrosis of any bones in the foot or ankle

  7. Pain of 8/10 or greater during walking

  8. Uncorrected visual or hearing impairments

  9. Require use of a knee stabilizing device to perform daily activities (i.e., Kneeankle foot orthosis, knee orthosis, etc.)

  10. Pregnancy

  11. Body mass index greater than 40 kg/m2

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Carbon Fiber Custom Dynamic Orthosis (CDO)
Phase:
Study Start date:
August 16, 2024
Estimated Completion Date:
September 01, 2025

Study 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. 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.

Connect with a study center

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

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