💬In plain words
What the trial is, and whether it could suit you
The primary purpose of this research study is to determine if forces within carbon fiber custom dynamic orthoses (CDOs) can be reliability assessed using Loadpad and Loadsol force measuring sensors (Novel GMBH, St. Paul, MN). An improved understanding of the forces acting within orthoses may help to guide future orthosis related research studies, provision methods, and patient education.
Study participants will consist of three groups; 1) healthy, able-bodied adult participants using generic sized CDOs, which consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that runs the length of the leg and bends to store and return energy, and a semi-rigid footplate that acts as a lever arm to bend the posterior strut, 2) individuals without peripheral neuropathy who use AFO(s) regularly, and 3) individuals with peripheral neuropathy who use AFO
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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