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Comparative Effect of Training Methods to Reduce Forefoot Loading in Carbon Fiber Custom Dynamic Orthoses

Jason Wilken · NCT07889765

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
51
US sites recruiting
1
Study start
November 1, 2026
Record last updated
October 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Carbon fiber custom dynamic orthoses (CDOs) include a full-length footplate, a stiff posterior spring, and a cuff that wraps around the leg below the knee. CDOs restore function after limb trauma, decrease forefoot loading, and reduce pain. However, initial introduction to a CDO is not consistent, so this study is being conducted to determine if different methods of training alter forefoot loading during gait. Unimpaired adult participants will be randomized to one of three groups: 1) no feedback, 2) visual feedback of forefoot force, and 3) visual feedback of cuff forces. All participants will walk at a controlled speed on a treadmill without the CDO, after initial introduction to the CDO, and after completing two rounds of training in the CDO.

Being studied: Carbon Fiber Custom Dynamic Orthosis

Conditions: Healthy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Ages 18-65.
  • Without current complaint of lower extremity pain, spine pain, open wounds or active infection.
  • Ability to hop without pain.
  • Ability to perform a full squat without pain.
  • 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).
  • Medical conditions or injuries that have limited participation in work or exercise in the last 6 months.
  • Medical conditions of injuries limiting function for greater than 6 weeks.
  • Uncorrected visual or hearing impairments.
  • Use of an assistive device.
  • Wounds preventing CDO use
  • Pregnancy
  • Body mass index greater than 35 kg/m2.

Recruiting US locations

  • University of Iowa

    Iowa City, IA 52242

    Site contact: Jason M Wilken, PT, PhD · 319-353-0431 · jason-wilken@uiowa.edu

Study contacts (from the official record)

  • Jason M Wilken, PT, PhD · 319-335-6857 · jason-wilken@uiowa.edu
  • Kirsten M Anderson, PhD · 319-353-0431 · kirsten-m-anderson@uiowa.edu
All healthy volunteers studies in Iowa →
Comparative Effect of Training Methods to Reduce Forefoot Loading… (NCT07889765) | Bored Studies