Effects of Different Foot Structures on Plantar Fasciitis and Therapeutic Footwear Intervention

Fasciitis Clinical Trial

Official title:

The Investigation of Biomechanical Mechanism of Different Foot Structures on Plantar Fasciitis and the Evaluation of Efficacy on Therapeutic Footwear

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01363375
• Other study ID #: NSC 97-2320-B-027-002-MY3
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2011
• Last updated: May 31, 2011
• Start date: June 2009
• Est. completion date: July 2011

Study information

• Verified date: February 2008
• Source: Chang Gung Memorial Hospital
• Contact: Shih-Cherng Lin, Master
• Phone: +886-3-3281200
• Email: scherng[@]adm.cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. With normal bilateral foot arch structure, unilateral flat foot or unilateral high arch foot

2. With no more musculoskeletal disorders or malalignment

3. With no degeneration of low-extremity joint

4. With no diabetes mellitus or peripheral neuropathy

5. With no injury and pain of low-extremity in recent three month.

Exclusion Criteria:

1. Painful disorders

2. Foot related disorders or deformity

3. Dorsal or plantar wound and trauma

4. Poor proprioception

5. Obvious abnormal gait pattern, such as midfoot strike

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar

Intervention

Procedure:
• Foot orthosis, footwear
flat insole, total contact insole , carbon fiber plate; general shoe and rocker sole shoe
• Foot orthosis, Footwear
flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe
• Foot orthosis, footwear
flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital@ Taoyuan	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. doi: 10.1016/j.clinbiomech.2009.08.003. Epub 2009 Sep 9. — View Citation

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. — View Citation

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. doi: 10.1242/jeb.025767. — View Citation

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. doi: 10.1111/j.1469-7580.2010.01261.x. Epub 2010 Jul 14. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Foot MRI image, foot plantar soft tissue material property.	Foot plantar soft tissue material property, such as elastic modulus(N/mm^2).	1 day	No