Effects of Different Foot Structures on Plantar Fasciitis and Therapeutic Footwear Intervention - Full Text View

Purpose

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.

Condition	Intervention
Fasciitis	Procedure: Foot orthosis, footwear Procedure: Foot orthosis, Footwear

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	The Investigation of Biomechanical Mechanism of Different Foot Structures on Plantar Fasciitis and the Evaluation of Efficacy on Therapeutic Footwear

Resource links provided by NLM:

MedlinePlus related topics: Dietary Fiber Foot Health

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:

Gait parameter, plantar pressure. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
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).

Secondary Outcome Measures:

Foot MRI image, foot plantar soft tissue material property. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Foot plantar soft tissue material property, such as elastic modulus(N/mm^2).

Estimated Enrollment:	40
Study Start Date:	June 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
normal foot Subjects with normal foot structure	Procedure: Foot orthosis, footwear flat insole, total contact insole , carbon fiber plate; general shoe and rocker sole shoe Other Names: Carbon fiber enhancement Rocker sole shoe
flat foot Subjects with flat foot structure.	Procedure: Foot orthosis, Footwear flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe Other Names: Carbon fiber enhancement Rocker sole shoe
high arch foot Subjects with high arch foot structure.	Procedure: Foot orthosis, footwear flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe Other Names: Carbon fiber enhancement Rocker sole shoe

Detailed Description:

The plantar fascia has long been considered to play an important role in the weight-bearing foot, both in static stance and in dynamic function. Various functional and structural roles have been indicated by virtue of its anatomical attachments. 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.

In this research, a plantar fascia specific finite element foot model with tibia will be reconstructed from magnetic resonance images obtained from subjects with normal foot, flat foot and high arch foot structures. The same subject will also serve for plantar soft tissue material property testing, gait analysis as well as plantar pressure measurement. The kinematic and kinetic data from both gait analysis and plantar pressure measurement will be used to validate the accuracy of dynamic finite element analysis. In addition, 20 normal, 10 flat foot and 10 high-arch foot subjects will also be recruited for gait analysis and plantar pressure measurement. The kinematic and kinetic data from both gait analysis and plantar pressure measurement will be compared with the results of finite element analysis.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Subjects with normal foot structure or abnormal foot structure (flat foot or high arch foot) will be invited to participant this study.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Painful disorders
Foot related disorders or deformity
Dorsal or plantar wound and trauma
Poor proprioception
Obvious abnormal gait pattern, such as midfoot strike

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363375

Contacts

Contact: Shih-Cherng Lin, Master	+886-3-3281200 ext 3846	scherng@adm.cgmh.org.tw
Contact: Weng-Pin Chen, PhD	+-886-2-27212171 ext 2082	wpchen@mail.ntut.edu.tw

Locations

Taiwan
Chang Gung Memorial Hospital@ Taoyuan	Recruiting
Taoyuan, Taiwan, 33342
Contact: Shih-Cherng Lin, Master +886-3-3196200 ext 2253 scherng@adm.cgmh.org.tw
Principal Investigator: Chih-Chin Hsu, MD,PhD

Sponsors and Collaborators

Chang Gung Memorial Hospital

National Science Council, Taiwan

Investigators

Principal Investigator:

Chih-Chin Hsu, MD, PhD

Chang Gung Memorial Hospital @ Keelung

More Information

Publications:

Boyer KA, Andriacchi TP. Changes in running kinematics and kinetics in response to a rockered shoe intervention. Clin Biomech (Bristol, Avon). 2009 Dec;24(10):872-6. Epub 2009 Sep 9.

Van 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.

Brown 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.

Caravaggi P, Pataky T, Günther 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. Epub 2010 Jul 14.

Caravaggi 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lin 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.

Responsible Party:	Chih-Chin Hsu, Department of physical medicine and rehabilitation, Chang Gung Memorial Hospital at Keelung
ClinicalTrials.gov Identifier:	NCT01363375 History of Changes
Other Study ID Numbers:	NSC 97－2320－B－027－002－MY3
Study First Received:	May 10, 2011
Last Updated:	May 31, 2011
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:

Plantar fascia
Plantar fasciitis
Foot orthosis

Finite element analysis
Gait analysis
Plantar pressure measurement

Additional relevant MeSH terms:

Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Carbon fiber
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013