Effect of Ankle-foot Orthoses Trim Line Modifications on Ankle and Knee Motion and Force.
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ClinicalTrials.gov Identifier: NCT01865682
Recruitment Status :
First Posted : May 31, 2013
Last Update Posted : October 6, 2017
Southern California Institute for Research and Education
Information provided by (Responsible Party):
Dana Craig, Southern California Institute for Research and Education
The purpose of this study is to quantify changes in ankle and knee motion and force resulting from five progressive modifications to the anterior-posterior trim lines of thermoformed ankle-foot orthoses (AFO). It is hypothesized that the AFO with the most anterior trim line will prevent the most plantar flexion during loading response (the first 10% of the gait cycle)and prevent the most dorsiflexion at terminal stance (from 30 to 50% of the gait cycle) as compared to the non-device condition. This will be evidenced by the sagittal plane ankle motion and ground reaction force magnitude and location during loading response and terminal stance. Additionally, the angular velocity of knee flexion will increase during these same periods. By contrast, as the trim lines are moved more posterior this will result in lowering the effective stiffness of the device which will result in progressive increases in dorsiflexion and allow increasing amounts of knee flexion during terminal stance.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 40 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
This study seeks to recruit younger, healthy (non-pathological) individuals over 18 years of age.
Participants must have no known pathology that would affect their ambulatory ability.
Age greater than or equal to 18 years, but less than 40 years.
Ability to tolerate walking for a minimum of 100 yards over the course of a three and a half hour time period.
No current skin breakdown or sores on either lower extremity.
Use of ambulatory aids such as canes or crutches.
Any medical or psychological condition that could jeopardize the subject's participation and compliance with the study protocol.