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

NCT06127316 | Recruiting FDA Device

• 2 other identifiers: 202302397CDMRP-OP230037
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Lower Limb Injury

Keywords

Plantar Force; Ankle Foot Orthosis; Carbon Fiber Orthosis; Biomechanics

Outcome Measures

Primary Outcomes (6)

• Peak Force (forefoot)

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

  Baseline

• Force Impulse (forefoot)

  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.

  Baseline

• Peak Force (hindfoot)

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

  Baseline

• Force Impulse (hindfoot)

  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.

  Baseline

• Numerical Pain Rating Scale

  Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable

  Baseline

• Modified Socket Comfort Score

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

  Baseline

Secondary Outcomes (7)

• Peak Force (total foot)

  Baseline

• Force Impulse (total foot)

  Baseline

• Peak Force (midfoot)

  Baseline

• Force Impulse (midfoot)

  Baseline

• Ankle Range of Motion

  Baseline

Other Outcomes (1)

• Semi-Structured Interview

  Baseline

Study Arms (4)

NoCDO

NO INTERVENTION

Participants will complete study activities without a CDO

0cm Distraction

EXPERIMENTAL

Participants will complete study activities while wearing a CDO with 0cm of heel distraction height

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

1cm Distraction

EXPERIMENTAL

Participants will complete study activities while wearing a CDO with 1cm of heel distraction height

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

2cm Distraction

EXPERIMENTAL

Participants will complete study activities while wearing a CDO with 2cm of heel distraction height

Device: Carbon Fiber Custom Dynamic Orthosis (CDO)

Interventions

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.

Also known as: Ankle Foot Orthosis (AFO)

0cm Distraction; 1cm Distraction; 2cm Distraction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead
• Fabtech Systems: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Study Officials

• Jason M Wilken, PT,PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason M Wilken, PT, PhD

CONTACT

3193356857; 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
• Masking Details: Participants will be blinded, to the greatest extent possible, to the different CDO heel distraction heights.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: In this study, forces acting under the foot (hindfoot, midfoot, forefoot, and total 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. Gait kinematics and kinetics will be measured using infra-red motion capture cameras (Vicon Motion Systems Ltd., Denver, CO) and force plates (AMTI, Watertown, MA). Testing order of the CDO conditions will be randomized to prevent influence of testing order.

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: August 16, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)