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

NCT ID: NCT01363375

Last Updated: 2011-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-07-31

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.

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.

Conditions

Fasciitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

normal foot

Subjects with normal foot structure

Foot orthosis, footwear

Intervention Type: PROCEDURE

flat insole, total contact insole , carbon fiber plate; general shoe and rocker sole shoe

flat foot

Subjects with flat foot structure.

Foot orthosis, Footwear

Intervention Type: PROCEDURE

flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe

high arch foot

Subjects with high arch foot structure.

Foot orthosis, footwear

Intervention Type: PROCEDURE

flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe

Interventions

Foot orthosis, footwear

flat insole, total contact insole , carbon fiber plate; general shoe and rocker sole shoe

Intervention Type: PROCEDURE

Foot orthosis, Footwear

flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe

Intervention Type: PROCEDURE

Foot orthosis, footwear

flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe

Intervention Type: PROCEDURE

Other Intervention Names

Carbon fiber enhancement; Rocker sole shoe; Carbon fiber enhancement; Rocker sole shoe; Carbon fiber enhancement; Rocker sole shoe

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Department of physical medicine and rehabilitation, Chang Gung Memorial Hospital at Keelung

Principal Investigators

Chih-Chin Hsu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Keelung

Locations

Chang Gung Memorial Hospital@ Taoyuan

Taoyuan District, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Shih-Cherng Lin, Master

Role: CONTACT

scherng@adm.cgmh.org.tw

+886-3-3281200 ext. 3846

Weng-Pin Chen, PhD

Role: CONTACT

wpchen@mail.ntut.edu.tw

+-886-2-27212171 ext. 2082

Facility Contacts

Shih-Cherng Lin, Master

Role: primary

scherng@adm.cgmh.org.tw

+886-3-3196200 ext. 2253

References

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.

Reference Type: BACKGROUND

PMID: 19744753 (View on PubMed)

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. doi: 10.1109/TNSRE.2005.858460.

Reference Type: BACKGROUND

PMID: 16425836 (View on PubMed)

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. doi: 10.1016/s0003-9993(03)00374-5.

Reference Type: BACKGROUND

PMID: 14970973 (View on PubMed)

Caravaggi 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.

Reference Type: BACKGROUND

PMID: 20646107 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19617443 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22884544 (View on PubMed)

Other Identifiers

NSC 97-2320-B-027-002-MY3

Identifier Type: -

Identifier Source: org_study_id