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

Completed

• Conditions: Lower Extremity Biomechanics

• Registration Number: NCT01865682
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-28
• Study First Posted: 2013-05-31
• Primary Completion: 2015-03
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sagittal plane ankle angle.	Six months

Secondary Outcome Measures

Name	Time	Method
Sagittal plane knee angle.	Six months

Trial Locations

Locations (1)

VA Long Beach Healthcare System; 🇺🇸 Long Beach, California, United States