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Clinical Trial Summary

The proposed study evaluates the effect of medial lateral wedge and carbon fiber custom dynamic orthosis (CDO) use on lower limb force and motion during walking. Previous work has used foam heel wedges to alter CDO alignment and resulting lower limb mechanics, and medial lateral foam wedges have been successfully used to treat unilateral knee osteoarthritis. In this study, medial lateral wedges will be placed in participants shoes, with the tall side of the wedge placed on the medial or lateral aspect of the shoes, and participants will walk at controlled and self-selected speeds and complete physical performance measures. Participants will also walk with no CDO. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis.


Clinical Trial Description

The primary purpose of this line of research is to investigate the effects of combined carbon fiber custom dynamic orthosis (CDO) and medial-lateral wedge use on biomechanics during gait in an effort to reduce unilateral knee compartment loading. It has been shown previously that use of a heel wedge with a CDO can affect gait biomechanics and medial-lateral wedging has been successfully used in treatment of knee osteoarthritis. Additional support and restriction of motion at the ankle associated with CDO use may emphasize results seen at the knee with medial-lateral wedging. Therefore, the proposed effort is designed to evaluate how different medial-lateral wedges placed under a CDO influence knee biomechanics during gait. The proposed study will provide evidence that can be used by physicians when treating knee osteoarthritis. In this research study, pilot data will be collected from a cohort of healthy adult participants with no history of lower limb injuries or functional deficits. Participants will be evaluated using a series of study measures under each of the four conditions; without a brace (NoCDO), with a brace and no wedge (CDO), with a brace and a medial wedge placed in the shoe (Medial), and with a brace and a lateral wedge placed in the shoe (Lateral). The wedge will be placed in a medial and lateral position to determine effectiveness of combined wedging and CDO use in treating both medial and lateral knee OA. Testing order will be randomized for each participant. Participants will walk on a level-ground walkway at self-selected and controlled speeds. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that the device and wedge don't negatively affect physical function. Questionnaires will be used to evaluate participants' pain and perception of comfort and smoothness for each condition. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05209360
Study type Interventional
Source University of Iowa
Contact Jason M Wilken
Phone 3193356857
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date March 2022
Completion date June 2023

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