Effects of Different Foot Structures on Plantar Fasciitis and Therapeutic Footwear Intervention
The Investigation of Biomechanical Mechanism of Different Foot Structures on Plantar Fasciitis and the Evaluation of Efficacy on Therapeutic Footwear
1 other identifier
observational
40
1 country
1
Brief Summary
Excessive repetitive loading concentrating upon plantar fascia is considered as the most influential factor in plantar fasciitis development. Abnormal foot structure may lead to high risk of plantar fasciitis. However, the biomechanical factor that may cause plantar fasciitis has not been thoroughly investigated. Orthotic device is a common treatment used for plantar fasciitis. However, there is no direct and quantitative data, such as stress and strain distribution of plantar fascia for patient with foot orthosis during gait. Therefore, the aim of this three-year project study is to investigate the biomechanical mechanism of different foot structures and to understand the biomechanical response of plantar fascia during stance phase of gait cycle by dynamic finite element analysis, gait analysis as well as plantar pressure measurement. In addition, the efficacy of foot orthoses will be evaluated by the same research process. The hypotheses are that flat foot and high arch foot may result in higher stress and strain upon plantar fascia during gait; the foot orthosis, such as total contact insole, carbon fiber plate and rocker bottom sole, would reduce stress and strain distribution around the calcaneal medial tuberosity; rigid and curved geometric bottom will be able to relief plantar fascia stretching during push-off phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2009
Typical duration for all trials
1 active site
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
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedJune 1, 2011
February 1, 2008
2.1 years
May 10, 2011
May 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gait parameter, plantar pressure.
Gait parameter, such as MTP joint range of motion(degree), meidal longitudinal arch angle(degree), hindfoot eversion/inversion angle(degree). Plantar pressure, such as peak pressure(kPa), center of pressure trajectory(mm/s).
1 day
Secondary Outcomes (1)
Foot MRI image, foot plantar soft tissue material property.
1 day
Study Arms (3)
normal foot
Subjects with normal foot structure
flat foot
Subjects with flat foot structure.
high arch foot
Subjects with high arch foot structure.
Interventions
flat insole, total contact insole , carbon fiber plate; general shoe and rocker sole shoe
Eligibility Criteria
Subjects with normal foot structure or abnormal foot structure (flat foot or high arch foot) will be invited to participant this study.
You may qualify if:
- With normal bilateral foot arch structure, unilateral flat foot or unilateral high arch foot
- With no more musculoskeletal disorders or malalignment
- With no degeneration of low-extremity joint
- With no diabetes mellitus or peripheral neuropathy
- With no injury and pain of low-extremity in recent three month.
You may not qualify if:
- Painful disorders
- Foot related disorders or deformity
- Dorsal or plantar wound and trauma
- Poor proprioception
- Obvious abnormal gait pattern, such as midfoot strike
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital@ Taoyuan
Taoyuan District, Taiwan, 33342, Taiwan
Related Publications (6)
Boyer KA, Andriacchi TP. Changes in running kinematics and kinetics in response to a rockered shoe intervention. Clin Biomech (Bristol). 2009 Dec;24(10):872-6. doi: 10.1016/j.clinbiomech.2009.08.003. Epub 2009 Sep 9.
PMID: 19744753BACKGROUNDVan Bogart JJ, Long JT, Klein JP, Wertsch JJ, Janisse DJ, Harris GF. Effects of the toe-only rocker on gait kinematics and kinetics in able-bodied persons. IEEE Trans Neural Syst Rehabil Eng. 2005 Dec;13(4):542-50. doi: 10.1109/TNSRE.2005.858460.
PMID: 16425836BACKGROUNDBrown D, Wertsch JJ, Harris GF, Klein J, Janisse D. Effect of rocker soles on plantar pressures. Arch Phys Med Rehabil. 2004 Jan;85(1):81-6. doi: 10.1016/s0003-9993(03)00374-5.
PMID: 14970973BACKGROUNDCaravaggi P, Pataky T, Gunther M, Savage R, Crompton R. Dynamics of longitudinal arch support in relation to walking speed: contribution of the plantar aponeurosis. J Anat. 2010 Sep;217(3):254-61. doi: 10.1111/j.1469-7580.2010.01261.x. Epub 2010 Jul 14.
PMID: 20646107BACKGROUNDCaravaggi P, Pataky T, Goulermas JY, Savage R, Crompton R. A dynamic model of the windlass mechanism of the foot: evidence for early stance phase preloading of the plantar aponeurosis. J Exp Biol. 2009 Aug;212(Pt 15):2491-9. doi: 10.1242/jeb.025767.
PMID: 19617443BACKGROUNDLin SC, Chen CP, Tang SF, Wong AM, Hsieh JH, Chen WP. Changes in windlass effect in response to different shoe and insole designs during walking. Gait Posture. 2013 Feb;37(2):235-41. doi: 10.1016/j.gaitpost.2012.07.010. Epub 2012 Aug 9.
PMID: 22884544DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chih-Chin Hsu, MD, PhD
Chang Gung Memorial Hospital, Keelung
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 10, 2011
First Posted
June 1, 2011
Study Start
June 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
June 1, 2011
Record last verified: 2008-02