Footplate stiffness effects on foot loading in carbon-fiber custom dynamic orthoses
The Effects of Footplate Stiffness on Foot Loading Within Carbon Fiber Custom Dynamic Orthoses
This test tries different footplate stiffness settings in carbon-fiber custom dynamic orthoses to see how they change foot pressure, walking mechanics, pain, and comfort for adults who can wear a CDO.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT07312032 on ClinicalTrials.gov |
What this trial studies
Researchers will measure forces under the foot and whole-limb mechanics while participants walk at a controlled speed in three conditions: without an orthosis, with a standard carbon-fiber custom dynamic orthosis (CDO), and with the CDO plus added carbon-fiber stiffening inserts. Wireless pressure insoles, motion-capture cameras, and force plates will record plantar loading and gait mechanics, and participants will complete questionnaires about pain and orthosis comfort after each condition. A contralateral heel lift will be provided if needed to prevent leg-length differences during testing. The protocol enrolls adults who can fit a generic CDO and perform basic functional tasks without pain.
Who should consider this trial
Good fit: Adults aged 18–65 who can fit a generic CDO, have no current lower-extremity or spine pain or recent limiting injuries, and can hop and squat without pain are the ideal participants.
Not a fit: People with ongoing lower-extremity injuries, recent surgeries, moderate-to-severe brain injury, or medical or sensory conditions that prevent safe walking or testing are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help clinicians select footplate stiffness to reduce harmful foot loading and improve comfort for people using carbon-fiber CDOs.
How similar studies have performed: Previous work shows CDOs can improve function, reduce pain, and that design features influence gait biomechanics, but the specific effect of footplate stiffness on foot loading has not been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Between the ages of 18 and 65 * Healthy without current complaint of lower extremity pain, spine pain, open wounds or active infections, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months * Able to hop without pain * Able to perform a full squat without pain * Ability to read and write in English and provide written informed consent * Ability to fit in a generic sized CDO Exclusion Criteria * Diagnosed with a moderate or severe brain injury * Lower extremity injury resulting in surgery or limiting function for greater than 6 weeks * Injuries that would limit performance in this study * Diagnosed with a physical or psychological condition that would preclude functional testing (e.g. cardiac condition, clotting disorder, pulmonary condition) * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing * Require use of an assistive device * Unhealed wounds (cuts/abrasions) that would prevent AFO use * BMI \> 40 * Pregnancy
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Jason M Wilken, PT, PhD
- Email: jason-wilken@uiowa.edu
- Phone: +1 319 3356857
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.