Actively Recruiting
Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff
Led by University of Iowa · Updated on 2025-12-31
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how forces inside carbon fiber custom dynamic orthoses (CDOs) can be reliably measured using special sensors called Loadpad and Loadsol. These devices support the foot and ankle, and understanding the forces within the orthosis, especially around the proximal cuff that wraps just below the knee, may improve future research, fitting methods, and patient guidance. The study involves three groups: healthy adults using generic CDOs, individuals without peripheral neuropathy who regularly use ankle foot orthoses (AFOs), and those with peripheral neuropathy who also use AFOs regularly. Participants will test different tightness levels of the proximal cuff, including self-selected tightness, loose, moderate, and tight fastening. The forces on the leg and foot will be measured using wireless sensors during activities such as sitting quietly, standing, and walking. Group 1 will experience randomized testing of the different cuff tightness, while Groups 2 and 3 will test their usual AFO tightness. The orthosis includes a carbon fiber footplate, posterior strut, and the proximal cuff. Throughout the study, participants will wear the orthoses under various conditions while researchers collect force data and have them complete questionnaires about comfort and pain. Primary measures include forces on the cuff and foot, pain levels, and comfort scores. This study runs from March 2024 through December 2026, with participants undergoing assessments at different cuff tightness levels and activity states to better understand the impact of fastening on orthosis function.
CONDITIONS
Brief Title
Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Group 1: Aged 18 to 65, healthy without recent lower limb or spine pain or disorders, able to hop and squat without pain, able to read and write English, and fit a generic sized CDO
- Group 2: Aged 18 to 90, regular AFO users without peripheral neuropathy, AFO compatible with sensors, used AFO at least 2 weeks, able to walk 50 feet unaided, able to read and write English
- Group 3: Aged 18 to 90, regular AFO users with peripheral neuropathy, AFO compatible with sensors, used AFO at least 2 weeks, able to walk 50 feet unaided, diagnosis of peripheral neuropathy, able to read and write English
You will not qualify if you...
- Group 1: Moderate or severe brain injury, lower limb injury limiting function >6 weeks, conditions preventing functional testing, assistive device use, unhealed wounds that prevent AFO use, BMI over 40, pregnancy
- Group 2 and 3: Peripheral neuropathy (only Group 2 excluded), moderate or severe brain injury, stroke, heart disease, need for knee stabilizing device, impairments limiting walking or instruction compliance, BMI over 40, pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session or multiple sessions as per trial procedures
Participants complete study activities while wearing the carbon fiber custom dynamic orthosis (CDO) with different proximal cuff tightness levels or without the CDO, to measure forces within the proximal cuff and assess comfort and plantar forces.
1 to 5 visits depending on orthosis conditions tested
Trial Site Locations
Total: 1 location
1
University of Iowa
Iowa City, Iowa, United States, 52241
Actively Recruiting
Research Team
J
Jason M Wilken, PT, PhD
K
Kirsten M Anderson, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
5
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