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

May 10, 2011
May 31, 2011
June 2009
July 2011   (final data collection date for primary outcome measure)
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).

Same as current
Complete list of historical versions of study NCT01363375 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
Effects of Different Foot Structures on Plantar Fasciitis and Therapeutic Footwear Intervention
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample

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

Fasciitis
  • 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
  • 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
  • normal foot
    Subjects with normal foot structure
    Intervention: Procedure: Foot orthosis, footwear
  • flat foot
    Subjects with flat foot structure.
    Intervention: Procedure: Foot orthosis, Footwear
  • high arch foot
    Subjects with high arch foot structure.
    Intervention: Procedure: Foot orthosis, footwear

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
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
Taiwan
 
NCT01363375
NSC 97-2320-B-027-002-MY3
Yes
Chih-Chin Hsu, Department of physical medicine and rehabilitation, Chang Gung Memorial Hospital at Keelung
Chang Gung Memorial Hospital
National Science Council, Taiwan
Principal Investigator: Chih-Chin Hsu, MD, PhD Chang Gung Memorial Hospital @ Keelung
Chang Gung Memorial Hospital
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP