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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01363375
First received: May 10, 2011
Last updated: May 31, 2011
Last verified: February 2008
  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:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 24, 2014