Status:
RECRUITING
Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff
Lead Sponsor:
University of Iowa
Conditions:
Healthy
Ankle Foot Orthosis (AFO)
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 (N...
Detailed Description
Ankle foot orthoses (AFOs) are medical devices often used to support the foot and ankle during daily activities. Carbon fiber custom dynamic orthoses (CDOs), one subset of AFOs, that consist of a prox...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06127264
Start Date
March 1 2024
End Date
December 31 2026
Last Update
December 31 2025
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52241