Effects of heel distraction height on foot loading with carbon fiber orthoses

Is this trial a fit for you?

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

What this trial studies

This study investigates how different heel distraction heights in carbon fiber custom dynamic orthoses (CDOs) affect foot loading and motion during walking in individuals with traumatic lower limb injuries. It aims to measure the forces acting under the foot using advanced wireless technology while also assessing patient-reported pain and comfort levels. By comparing the performance of CDOs to unloading ankle foot orthoses (AFOs), the study seeks to understand the biomechanical differences and their implications for rehabilitation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Ages 18-65 years
2. Traumatic hindfoot injury (soft tissue injury or fracture affecting the hindfoot or ankle)
3. Mechanical pain with limb loading (\>=4/10 on Numerical Pain Rating Scale)
4. Ability to walk 50 feet at a slow to moderate pace
5. Ability to walk without a cane or crutch
6. Ability to read and write in English and provide written informed consent

Exclusion Criteria:

1. Diagnosis with a moderate or severe brain injury
2. Diagnosis with a physical or psychological condition that would preclude functional testing (e.g., cardiac condition, clotting disorder, pulmonary condition, etc.
3. Ankle weakness resulting from spinal cord injury or central nervous system pathology
4. Nerve, muscle, bone, or other condition limiting function in the contralateral extremity
5. Rheumatoid or inflammatory arthritis
6. Necrosis of any bones in the foot or ankle
7. Pain of 8/10 or greater during walking
8. Uncorrected visual or hearing impairments
9. Require use of a knee stabilizing device to perform daily activities (i.e., Knee ankle foot orthosis, knee orthosis, etc.)
10. Pregnancy
11. Body mass index greater than 40 kg/m2

Where it's running

• University of Iowa
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Jason M Wilken, PT,PhD — University of Iowa
• Study coordinator: Jason M Wilken, PT, PhD
• Email: jason-wilken@uiowa.edu
• Phone: 3193356857

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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.