Status:

COMPLETED

Iterative Design of Custom Dynamic Orthoses

Lead Sponsor:

University of Iowa

Conditions:

Adult ALL

Healthy

Eligibility:

All Genders

18-50 years

Phase:

NA

Brief Summary

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 st...

Detailed Description

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....

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study

Key Trial Info

Start Date :

April 21 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 25 2022

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT04800510

Start Date

April 21 2021

End Date

June 25 2022

Last Update

December 5 2023

Active Locations (1)

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1

The University of Iowa

Iowa City, Iowa, United States, 52242