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Clinical trial Recruiting at 5 sites Interventional Ages 18 to 65

Evaluating custom dynamic orthoses for foot injuries

Official title: From Opinion to Evidence: Multi-site Evaluation of Custom Dynamic Orthosis Best Practices

Run by University of Iowa · NCT06352788 · Data updated 2026-11-12

This study is testing how different styles of custom foot braces can help adults with long-term injuries recover better and move more easily.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment35 (estimated)
SponsorUniversity of Iowa
Academic / other
Locations5 sites (San Diego, California and 4 other locations)
StatusRecruiting
StartedJuly 2, 2024
Main results expectedAugust 31, 2027
Study endsSeptember 1, 2028
Registry record updatedOctober 21, 2026
Trial IDNCT06352788 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 65 who have experienced a traumatic injury below the knee and have ongoing mobility issues for over two years.

Probably not a fit

Patients with severe pain at rest, non-ambulatory status, or those requiring imminent surgery on the affected limb may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates how different configurations of two types of carbon fiber custom dynamic orthoses (CDOs) affect recovery outcomes in adults with traumatic lower extremity injuries. Participants, aged 18 to 65 and experiencing ongoing deficits more than two years post-injury, will be randomized to receive either a modular or monolithic CDO. They will undergo assessments without the orthosis and with the CDO in three configurations to determine the optimal setup for improving mobility and function. Established tests will be utilized to compare the effectiveness of each configuration.

Why it matters

Potential benefit: If successful, this study could lead to improved rehabilitation strategies for patients with foot injuries, enhancing their mobility and quality of life.

How similar studies have gone: Other studies have shown promise in using custom orthoses for rehabilitation, but this specific evaluation of configurations is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Between the ages of 18 and 65
* 2 or more years from a traumatic injury below the knee
* Ability to be fit with an orthosis
* Any of the following:

  * Weakness of ankle plantarflexors (\<4/5 on manual muscle test)
  * Limited pain-free ankle motion (dorsiflexion (DF) \<10° or plantarflexion (PF) \<20°)
  * Mechanical pain with loading to hindfoot/midfoot (\>=4/10 Numerical pain rating scale)
  * Fusion or candidate for fusion of the ankle or hindfoot
  * Candidate for amputation secondary to ankle/foot injury and impairment

Exclusion Criteria:

* Pain greater than 8/10 at rest
* Ankle weakness or spasticity as a result of spinal cord injury or central nervous system pathology
* Use of an orthosis including the knee
* Non-ambulatory
* Surgery on study limb anticipated in next 4 months
* Medical or psychological conditions that would influence functional testing (e.g., severe traumatic brain injury, stroke, heart disease, vestibular disorder)
* Neurologic, musculoskeletal, or other conditions limiting function of the contralateral extremity
* Uncorrected visual or hearing impairments
* Pregnancy
* Non-English speaking
* BMI \> 40

Where it's running

  • Naval Medical Center San Diego - Clinical Biomechanics Laboratory
    San Diego, California, United States     Recruiting
  • University of Iowa
    Iowa City, Iowa, United States     Recruiting
  • Minneapolis VA Health Care System - Motion Analysis Laboratory
    Minneapolis, Minnesota, United States     Recruiting
  • Mayo Clinic - Motion Analysis Lab
    Rochester, Minnesota, United States     Recruiting
  • Vanderbilt University - Zelik Lab For Biomechanics & Assistive Technology
    Nashville, Tennessee, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Foot Injury 3University of Iowa 828
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.