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

May 31, 2011 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 33342
        • Recruiting
        • Chang Gung Memorial Hospital@ Taoyuan
        • Contact:
        • Principal Investigator:
          • Chih-Chin Hsu, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait parameter, plantar pressure.
Time Frame: 1 day

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot MRI image, foot plantar soft tissue material property.
Time Frame: 1 day
Foot plantar soft tissue material property, such as elastic modulus(N/mm^2).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Science Council, Taiwan

Investigators

  • Principal Investigator: Chih-Chin Hsu, MD, PhD, Chang Gung Memorial Hospital @ Keelung

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSC 97-2320-B-027-002-MY3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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