Assessing force measurement in carbon fiber orthoses
Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff
This study is testing how well special sensors can measure force in carbon fiber ankle-foot braces to see how they work for healthy people and those with nerve issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06127264 on ClinicalTrials.gov |
What this trial studies
This research focuses on evaluating the reliability of force measurements within carbon fiber custom dynamic orthoses (CDOs) using specialized sensors. Participants will be divided into three groups: healthy adults, individuals without peripheral neuropathy using ankle foot orthoses (AFOs), and individuals with peripheral neuropathy using AFOs. The study aims to enhance understanding of how the proximal cuff of the orthosis affects force distribution and patient outcomes. Insights gained may inform future orthosis design and patient education.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18 to 65 who can perform physical activities without pain.
Not a fit: Patients with moderate to severe brain injuries or significant lower extremity injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved designs of orthoses that better support patients and enhance their mobility.
How similar studies have performed: While previous studies have explored various aspects of AFOs, this specific investigation into the proximal cuff's impact is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Group 1 - Able Bodied Participants 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 Group 2 - AFO Users without Peripheral Neuropathy Inclusion Criteria: * Between the ages of 18 and 90 * Use an AFO(s) for daily activities * The AFO(s) proximal cuff is compatible with loadpad sensors * Have used their AFO(s) for a minimum of 2 weeks * Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.) * Ability to read and write in English and provide written informed consent Exclusion Criteria * Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments * Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease) * Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing * BMI \> 40 * Pregnancy Group 3 - AFO Users with Peripheral Neuropathy Inclusion Criteria: * Between the ages of 18 and 90 * Use an AFO(s) for daily activities * The AFO(s) proximal cuff is compatible with loadpad sensors * Have used their AFO(s) for a minimum of 2 weeks * Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.) * Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments * Ability to read and write in English and provide written informed consent Exclusion Criteria * Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease) * Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities * Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing * BMI \> 40 * Pregnancy
Where this trial is running
Iowa City, Iowa
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Principal investigator: Jason Wilken, PT,PhD — University of Iowa
- Study coordinator: Jason M Wilken, PT, PhD
- Email: jason-wilken@uiowa.edu
- Phone: 3193356857
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.