Lower Extremity BiomechanicsNCT01865682
Effect of Ankle-foot Orthoses Trim Line Modifications on Ankle and Knee Motion and Force.
An observational study of Lower Extremity Biomechanics, run by Southern California Institute for Research and Education at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Extremity Biomechanics
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study seeks to recruit younger, healthy (non-pathological) individuals over 18 years of age.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Long Beach Healthcare System
Long Beach, California, 90822
About this study
Official title: Effects of Varying Trim Lines of Solid Ankle-foot Orthoses on Ankle and Knee Kinematics and Kinetics During Stance Phase.
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.
- Conditions
- Lower Extremity Biomechanics
- Keywords
- Ankle, Knee, Orthosis, Kinematics, Kinetics
What is being measured
The primary outcome is the main question the study is designed to answer.
Sagittal plane ankle angle.
Measured: Six months
Secondary outcomes (1)
Sagittal plane knee angle.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startDec 2012
- Primary completionMar 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lower Extremity BiomechanicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dana Craig, Southern California Institute for Research and Education
- Investigators
- Dana D. Craig, MA, Principal investigator, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865682
- Sponsor's protocol ID
- VALB-1215
- Status last verified
- Oct 2017
- First submitted
- 28 May 2013
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hsu, J., Michael, J., Fisk, J. (2008) AAOS Atlas of Orthoses and Assistive Devices. Mosby Inc., Elsevier, Inc. Pennsylvania
Lusardi, M. and Nielsen, C.(2007) Orthotics and Prosthetics in Rehabilitation. Elsevier, Inc. Missouri
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.
PubMed 11995890Jagadamma 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.
PubMed 20738231Radtka 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.
PubMed 15760746Desloovere 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.
PubMed 16934470
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Varying Trim Lines of Solid Ankle-foot Orthoses on Ankle and Knee Kinematics and Kinetics During Stance Phase.
- ClinicalTrials.gov ID
- NCT01865682
- Acronym / sponsor ID
- VALB-1215
- Conditions
- Lower Extremity Biomechanics
- Keywords
- Ankle, Knee, Orthosis, Kinematics, Kinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Southern California Institute for Research and EducationUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study seeks to recruit younger, healthy (non-pathological) individuals over 18 years of age.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sagittal plane ankle angle.
Time frame: Six months
1 secondary outcome
Sagittal plane knee angle.
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- BackgroundHsu, J., Michael, J., Fisk, J. (2008) AAOS Atlas of Orthoses and Assistive Devices. Mosby Inc., Elsevier, Inc. Pennsylvania
- BackgroundLusardi, M. and Nielsen, C.(2007) Orthotics and Prosthetics in Rehabilitation. Elsevier, Inc. Missouri
- Background: PubMed 11995890White 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.
- Background: PubMed 20738231Jagadamma 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.
- Background: PubMed 15760746Radtka 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.
- Background: PubMed 16934470Desloovere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana D. Craig, MA principal investigator
VA Long Beach Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Extremity Biomechanics, run by Southern California Institute for Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sagittal plane ankle angle. (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01865682, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2017.