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Study of Force Measurement in Carbon Fiber Orthoses

This study is looking at how reliably we can measure forces within a Carbon Fiber Custom Dynamic Orthosis (CDO). A CDO is a type of Ankle Foot Orthosis (AFO), which is a device that supports your foot and ankle. The CDO has a part that wraps around your leg below the knee (proximal cuff), a strut that runs down your leg, and a footplate. Researchers want to understand these forces better to improve how orthoses are designed and used. You might be able to join if you are a healthy adult between 18 and 65 years old, without leg or spine pain, and can hop and squat without pain. The study will measure the force in the proximal cuff, and the peak and impulse (total amount) of force on the bottom of the foot at the beginning of the study.

Study design
This is an interventional study with a planned enrollment of 60 participants. It is not specified if the study is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Measurements for this study are taken at Baseline, meaning at the start of your participation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06127264

Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

Recruiting
NAAges 18–90Interventional
University of Iowa
~60 participants
Updated 2025-12-31 on ClinicalTrials.gov
What's tested:Carbon Fiber Custom Dynamic Orthosis (CDO)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proximal Cuff Force
Measured over Baseline
+4 more outcomes measured

Conditions

Healthy
Ankle Foot Orthosis (AFO)
Peripheral Neuropathy

Explore related trials

Ankle Foot OrthosisHealthyPeripheral Neuropathy

Where it's being run

1 sites across 1 states
Iowa1

Study leadership

  • Jason Wilken, PT,PhD · PRINCIPAL_INVESTIGATOR · University of Iowa

Who to contact

Jason M Wilken, PT, PhD
[email protected]
3193356857
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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
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

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
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
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

What this trial measures

  • Proximal Cuff ForceBaseline

    Proximal cuff forces (N) will be measured as participants sit, stand, and walk without a CDO and in each CDO condition.

  • Peak Plantar ForceBaseline

    Plantar forces (N) will be measured across the total foot, the hindfoot, midfoot, and forefoot as participants sit, stand, and walk without a CDO and in each CDO condition.

  • Plantar Force ImpulseBaseline

    Plantar force impulse (Ns) across the total foot, the hindfoot, midfoot, and forefoot will be calculated using the integral of the force over the stance phase as participants sit, stand, and walk without a CDO and in each CDO condition.

  • Numerical Pain Rating ScaleBaseline

    Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable

  • Modified Socket Comfort Score (Comfort)Baseline

    Comfort scores range from 0 = most uncomfortable to 10 = most comfortable