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OpenTrials
Completed

NCT Number: NCT01865682

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

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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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sagittal plane ankle angle.

    Time frame: Six months

Secondary outcomes

  1. Sagittal plane knee angle.

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

Southern California Institute for Research and Education

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
May 31, 2013
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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