Effect of Ankle-foot Orthoses Trim Line Modifications on Ankle and Knee Motion and Force.

October 5, 2017 updated by: Dana Craig, Southern California Institute for Research and Education

Effects of Varying Trim Lines of Solid Ankle-foot Orthoses on Ankle and Knee Kinematics and Kinetics During Stance Phase.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study seeks to recruit younger, healthy (non-pathological) individuals over 18 years of age.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sagittal plane ankle angle.
Time Frame: Six months
Six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sagittal plane knee angle.
Time Frame: Six months
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California Institute for Research and Education

Investigators

  • Principal Investigator: Dana D. Craig, MA, VA Long Beach Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Actual)

October 6, 2017

Last Update Submitted That Met QC Criteria

October 5, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VALB-1215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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