Assessing force measurement in 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 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.

Why it matters

Who can join: the full rules

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

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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.