Iterative Design of Custom Dynamic Orthoses

Completed · Not applicable

Conditions studied: Adult ALL, Healthy

In brief

The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.

Key facts

Study ID

NCT04800510

Run by

University of Iowa

People needed

9

Starts

2021-04-21

Expected to finish

2022-06-25

Last updated by the study team

2026-01-30

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between the ages of 18 and 50
• Shoe size between women's 8 and 13.5 or men's 6.5 and 12
• Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
• Full active range of motion of the bilateral lower extremities and spine
• Ability to hop without pain
• Ability to perform a full squat without pain
• Ability to read and write in English and provide written informed consent

You may not qualify if…

• Diagnosed moderate or severe brain injury
• Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
• Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
• Visual or hearing impairment that would interfere with instructions given during testing
• Require an assistive device
• Wounds to the foot or calf that would prevent CDO use
• BMI greater than 35
• Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study

Where it is running

• The University of Iowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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