Clinical trial NCT01865682: Effect of Ankle-foot Orthoses Trim Line Modifications on Ankle and Knee Motion and Force.
Official title: Effects of Varying Trim Lines of Solid Ankle-foot Orthoses on Ankle and Knee Kinematics and Kinetics During Stance Phase.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Extremity Biomechanics
Keywords: Ankle
Knee
Orthosis
Kinematics
Kinetics
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study seeks to recruit younger, healthy (non-pathological) individuals over 18 years of age.

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.


Eligibility 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.

Primary outcomes:
measure: Sagittal plane ankle angle.
timeFrame: Six months
Secondary outcomes:
measure: Sagittal plane knee angle.
timeFrame: Six months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
Study officials:
affiliation: VA Long Beach Healthcare System
name: Dana D. Craig, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu, J., Michael, J., Fisk, J. (2008) AAOS Atlas of Orthoses and Assistive Devices. Mosby Inc., Elsevier, Inc. Pennsylvania
citation: Lusardi, M. and Nielsen, C.(2007) Orthotics and Prosthetics in Rehabilitation. Elsevier, Inc. Missouri
citation: White H, Jenkins J, Neace WP, Tylkowski C, Walker J. Clinically prescribed orthoses demonstrate an increase in velocity of gait in children with cerebral palsy: a retrospective study. Dev Med Child Neurol. 2002 Apr;44(4):227-32. doi: 10.1017/s0012162201001992.
citation: Jagadamma KC, Owen E, Coutts FJ, Herman J, Yirrell J, Mercer TH, Van Der Linden ML. The effects of tuning an ankle-foot orthosis footwear combination on kinematics and kinetics of the knee joint of an adult with hemiplegia. Prosthet Orthot Int. 2010 Sep;34(3):270-6. doi: 10.3109/03093646.2010.503225.
citation: Radtka SA, Skinner SR, Johanson ME. A comparison of gait with solid and hinged ankle-foot orthoses in children with spastic diplegic cerebral palsy. Gait Posture. 2005 Apr;21(3):303-10. doi: 10.1016/j.gaitpost.2004.03.004.
citation: Desloovere K, Molenaers G, Van Gestel L, Huenaerts C, Van Campenhout A, Callewaert B, Van de Walle P, Seyler J. How can push-off be preserved during use of an ankle foot orthosis in children with hemiplegia? A prospective controlled study. Gait Posture. 2006 Oct;24(2):142-51. doi: 10.1016/j.gaitpost.2006.08.003. Epub 2006 Aug 24.