Comparing Training Methods to Reduce Forefoot Loading with a Carbon Fiber Dynamic Orthosis
Official title: Comparative Effect of Training Methods to Reduce Forefoot Loading in Carbon Fiber Custom Dynamic Orthoses
Run by University of Iowa · NCT07889765 · Data updated 2026-11-12
This study tests whether different training methods (no feedback, visual feedback of forefoot force, or visual feedback of cuff forces) help healthy adults use a carbon fiber dynamic ankle-foot orthosis more effectively during walking.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 51 (estimated) |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Status | Recruiting |
| Started | November 1, 2026 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07889765 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults ages 18-65 without current lower-extremity pain or active infection, able to hop and perform a full squat without pain, and able to read/write in English.
✕Probably not a fit
Individuals with significant brain injury, serious medical or orthopedic conditions, recent injuries limiting activity, uncorrected sensory impairments, use of an assistive device, wounds preventing CDO use, pregnancy, or BMI over 35 kg/m2 may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Healthy adults will be randomized to one of three training groups to see how different feedback approaches influence forefoot loading while walking. Participants will walk on a treadmill at a controlled speed without the orthosis, after an initial introduction to the device, and after two training rounds with the device. Forefoot and cuff forces will be measured with wireless sensors, and participants will complete questionnaires on pain and comfort. The goal is to determine if training method affects forefoot loading and overall usability of the carbon fiber dynamic orthosis. The study uses a captive, unimpaired population to explore optimization of initial CDO use.
Why it matters
Potential benefit: If successful, training methods could reduce forefoot loading and pain, improving comfort and adherence to CDO use.
How similar studies have gone: Prior research suggests that training and feedback can influence force distribution during gait with assistive devices; this study builds on that approach in unimpaired adults.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ages 18-65. 2. Without current complaint of lower extremity pain, spine pain, open wounds or active infection. 3. Ability to hop without pain. 4. Ability to perform a full squat without pain. 5. 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). 3. Medical conditions or injuries that have limited participation in work or exercise in the last 6 months. 4. Medical conditions of injuries limiting function for greater than 6 weeks. 5. Uncorrected visual or hearing impairments. 6. Use of an assistive device. 7. Wounds preventing CDO use 8. Pregnancy 9. Body mass index greater than 35 kg/m2.
Where it's running
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University of Iowa
Iowa City, Iowa, United States Recruiting
Study contacts
- Study coordinator: Jason M Wilken, PT, PhD
- Email: jason-wilken@uiowa.edu
- Phone: 319-335-6857
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.