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
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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(s) regularly. . Group 1 participants will be asked to fasten the proximal cuff to a self-selected cuff tightness 'SSCT', as well as three different predefined force levels; 'Loose' where the proximal cuff is loosely fastened around the participants leg, 'Moderate' where the proximal cuff is fastened with moderate tightness, and 'Tight' where the proximal cuff is tightly fastened around the participants leg. Testing in the predetermined force levels (Loose, Moderate, Tight) will occur in a randomized order. Group 2 and Group 3 participants will be asked to fasten their AFO(s) to a self-selected 'SSCT' tightness. For all groups, forces acting on the leg, within the proximal cuff, will be measured using wireless Loadpad sensors and forces acting on the foot will be measured using wireless Loadsol insoles. Testing will include collection of force data as participants sit quietly, stand quietly, and walk and completion of questionnaires.
CONDITIONS
Official Title
Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Group 1: Age 18 to 65 years
- Group 1: Healthy adults without recent lower extremity or spine pain, wounds, infections, or medical/neuromusculoskeletal disorders limiting work or exercise in last 6 months
- Group 1: Able to hop and perform a full squat without pain
- Group 1: Able to read and write English and provide informed consent
- Group 1: Able to fit in a generic sized carbon fiber custom dynamic orthosis (CDO)
- Group 2 and 3: Age 18 to 90 years
- Group 2 and 3: Use an ankle foot orthosis (AFO) regularly for daily activities
- Group 2 and 3: AFO proximal cuff compatible with Loadpad sensors
- Group 2 and 3: Used AFO for at least 2 weeks
- Group 2 and 3: Able to walk 50 feet without assistive device
- Group 2 and 3: Able to read and write English and provide informed consent
- Group 3: Diagnosed or indicated peripheral neuropathy by Semmes Weinstein Filaments
You will not qualify if you...
- Group 1: Moderate or severe brain injury diagnosis
- Group 1: Lower extremity injury requiring surgery or limiting function for over 6 weeks
- Group 1: Injuries limiting study performance
- Group 1: Physical or psychological conditions preventing functional testing (e.g., cardiac, clotting, pulmonary conditions)
- Group 1: Visual or hearing impairments limiting walking or ability to follow instructions
- Group 1: Use of assistive device
- Group 1: Unhealed wounds preventing AFO use
- Group 1: Body mass index (BMI) over 40
- Group 1: Pregnancy
- Group 2 and 3: Peripheral neuropathy diagnosis (excluded in Group 2)
- Group 2 and 3: Medical or psychological conditions preventing functional testing (e.g., brain injury, stroke, heart disease)
- Group 2 and 3: Need for knee stabilizing device for daily activities
- Group 2 and 3: Visual or hearing impairments limiting walking or compliance
- Group 2 and 3: BMI over 40
- Group 2 and 3: Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
K
Kirsten M Anderson, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here