Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Adult ALL
  • Healthy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: All participants will be tested wearing no brace and two braces of differing stiffness's. The testing order will be randomized for each participant to prevent testing order from influencing study results.Masking: Single (Participant)Masking Description: Participants will be blinded to the stiffness of each brace. Braces will be labeled A and B, with stiffness only known by research staff.Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 45 years
Gender
Both males and females

Description

Healthy adult individuals will be invited to participate in this study, at the University of Iowa, that involves one visit lasting 3-4 hours. The primary purpose of this work is to determine the effects of Malleo-Lok stiffness on gait biomechanics and ankle joint stiffness. Previous work has highlig...

Healthy adult individuals will be invited to participate in this study, at the University of Iowa, that involves one visit lasting 3-4 hours. The primary purpose of this work is to determine the effects of Malleo-Lok stiffness on gait biomechanics and ankle joint stiffness. Previous work has highlighted the effects of ankle foot orthosis stiffness on gait using devices with a traditional single posterior strut opposed to the Malleo-Lok, which has two laterally positioned struts. Orthosis stiffness is an important factor to consider during device prescription and manufacturing. The ability to tune overall joint level stiffness by determining the combined effects of biological limb stiffness and orthosis stiffness will enhance precision medicine when treating individuals who require an orthosis for daily activities. The secondary purpose of this research study is to determine the within session repeatability of a novel approach for in-vivo AFO stiffness testing. AFO stiffness testing is typically performed using mechanical testing systems without accounting for the interaction of the individual and the device. During the visit to the University of Iowa campus participants will review a list of inclusion and exclusion criteria to determine their eligibility for this study. Eligible participants will review an informed consent document and have the chance to ask any questions they may have. Study staff will thoroughly explain the informed consent document and answer all questions. Upon signing the informed consent document study activities will begin. Participants will complete all study activities wearing no brace and two braces of differing stiffness's. Anthropometric and demographic information will be collected from each participant. The investigators will also use a motion capture system to evaluate gait biomechanics and ankle joint stiffness. Participants will walk at a self-selected and a controlled speed to evaluate gait biomechanics, and will stand in the motion capture system and bring their knee forward over the foot to evaluate ankle joint stiffness. Participants will be provided visual feedback of muscle activity to minimize lower limb muscle activity during ankle stiffness testing. Results from the proposed study will provide information about the effects of orthosis stiffness on gait biomechanics and ankle joint stiffness. Study results will be made available to clinicians to use when prescribing and fitting individuals with ankle foot orthoses.

Tracking Information

NCT #
NCT04806100
Collaborators
Not Provided
Investigators
Principal Investigator: Jason M Wilken, PT, PhD University of Iowa