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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 : Completed
First Posted : May 31, 2013
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Dana Craig, Southern California Institute for Research and Education

Brief Summary:
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.

Condition or disease
Lower Extremity Biomechanics

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Varying Trim Lines of Solid Ankle-foot Orthoses on Ankle and Knee Kinematics and Kinetics During Stance Phase.
Actual Study Start Date : December 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health




Primary Outcome Measures :
  1. Sagittal plane ankle angle. [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Sagittal plane knee angle. [ Time Frame: Six months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study seeks to recruit younger, healthy (non-pathological) individuals over 18 years of age.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865682


Locations
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United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Sponsors and Collaborators
Southern California Institute for Research and Education
Investigators
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Principal Investigator: Dana D. Craig, MA VA Long Beach Healthcare System

Publications:
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Responsible Party: Dana Craig, Health System Specialist, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01865682     History of Changes
Other Study ID Numbers: VALB-1215
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Keywords provided by Dana Craig, Southern California Institute for Research and Education:
Ankle
Knee
Orthosis
Kinematics
Kinetics