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RecruitingNot ApplicableNCT06710119

Effect of Custom Dynamic Orthoses on Forefoot Loading

Sponsor

University of Iowa

Enrollment

60 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Summary

The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • Ages: 18-65
  • Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
  • Shoe size between women's 8 and 13.5 or men's 6.5 and 13
  • Any of the following: weakness of ankle plantarflexors (<4/5 on MMT), limited pain free ankle motion (DF<10deg or PF<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
  • Ability to walk 25 feet without using a cane or crutch
  • Ability to walk at a slow to moderate pace
  • Able to read and write in English and provide written informed consent

Exclusion Criteria8

  • Pain > 9/10 while walking
  • Ankle weakness as a result of spinal cord injury or central nervous system pathology
  • AFO or CDO prescription that includes a knee brace or goes up to thigh
  • Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
  • Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
  • BMI greater than 40
  • Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
  • Pregnancy

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Interventions

OTHERVisual Feedback

Visual feedback of foot loading during gait.

Locations(2)

University of Iowa

Iowa City, Iowa, United States

Cornerstone Prosthetics and Orthotics

Everett, Washington, United States

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NCT06710119