NCT01865682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.2 years

First QC Date

May 28, 2013

Last Update Submit

October 5, 2017

Conditions

Lower Extremity Biomechanics

Keywords

AnkleKneeOrthosisKinematicsKinetics

Outcome Measures

Primary Outcomes (1)

  • Sagittal plane ankle angle.

    Six months

Secondary Outcomes (1)

  • Sagittal plane knee angle.

    Six months

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study seeks to recruit younger, healthy (non-pathological) individuals over 18 years of age.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

Related Publications (6)

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

    BACKGROUND

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

    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.

    PMID: 11995890BACKGROUND

  • 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.

    PMID: 20738231BACKGROUND

  • 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.

    PMID: 15760746BACKGROUND

  • 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.

    PMID: 16934470BACKGROUND

Study Officials

  • Dana D. Craig, MA

    VA Long Beach Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Health System Specialist

Study Record Dates

First Submitted

May 28, 2013

First Posted

May 31, 2013

Study Start

December 1, 2012

Primary Completion

March 1, 2015

Study Completion

June 1, 2017

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

US(1)