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

NCT ID: NCT01865682

Last Updated: 2017-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Lower Extremity Biomechanics

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southern California Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Dana Craig

Health System Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dana D. Craig, MA

Role: PRINCIPAL_INVESTIGATOR

VA Long Beach Healthcare System

Locations

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VA Long Beach Healthcare System

Long Beach, California, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 11995890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20738231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15760746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16934470 (View on PubMed)

Other Identifiers

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VALB-1215

Identifier Type: -

Identifier Source: org_study_id