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

Conditions

• Traumatic Lower Limb Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Aug 16, 2024

Status verified

Dec 2025

Primary completion

Jun 1, 2026

Completion

Jun 1, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Arms

• No Intervention: NoCDO
  Participants will complete study activities without a CDO
• Experimental: 0cm Distraction
  Participants will complete study activities while wearing a CDO with 0cm of heel distraction height
• Experimental: 1cm Distraction
  Participants will complete study activities while wearing a CDO with 1cm of heel distraction height
• Experimental: 2cm Distraction
  Participants will complete study activities while wearing a CDO with 2cm of heel distraction height

Primary Outcome Measure

Peak Force (forefoot) [ Time Frame: Baseline ]

Central Contacts

• Jason M Wilken, PT, PhD
  3193356857
  [email protected]
• Kirsten M Anderson, PhD
  3193530431
  [email protected]

Locations (1)

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