This trial is active, not recruiting.

Condition lower extremity biomechanics
Sponsor Southern California Institute for Research and Education
Start date December 2012
End date March 2015
Trial size 10 participants
Trial identifier NCT01865682, VALB-1215


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Sagittal plane ankle angle.
time frame: Six months

Secondary Outcomes

Sagittal plane knee angle.
time frame: Six months

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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.

Additional Information

Official title Effects of Varying Trim Lines of Solid Ankle-foot Orthoses on Ankle and Knee Kinematics and Kinetics During Stance Phase.
Principal investigator Dana D. Craig, MA
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Southern California Institute for Research and Education.