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

Lower Extremity Biomechanics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865682
• Other study ID #: VALB-1215
• Status: Completed
• Phase: N/A
• First received: May 28, 2013
• Last updated: October 5, 2017
• Start date: December 2012
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: Southern California Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2017
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Extremity Biomechanics

Locations

Country	Name	City	State
United States	VA Long Beach Healthcare System	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California Institute for Research and Education

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. Epub 2006 Aug 24. — View Citation

Hsu, J., Michael, J., Fisk, J. (2008) AAOS Atlas of Orthoses and Assistive Devices. Mosby Inc., Elsevier, Inc. Pennsylvania

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. — View Citation

Lusardi, M. and Nielsen, C.(2007) Orthotics and Prosthetics in Rehabilitation. Elsevier, Inc. Missouri

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sagittal plane ankle angle.		Six months
Secondary	Sagittal plane knee angle.		Six months