CClinicalTrials.gg
Status unknownNCT01363375Updated Jun 1, 2011

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

An observational study in Fasciitis, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-01.

Sponsored by Chang Gung Memorial Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2008), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Fasciitis

Keywords

  • Plantar fascia
  • Plantar fasciitis
  • Foot orthosis
  • Finite element analysis
  • Gait analysis
  • Plantar pressure measurement
03

In context

Fasciitis

235 studies on the registry are indexed under Fasciitis; 37 are open to participants now.

This study's planned enrollment of 40 is below the median of 75 across 36 observational studies indexed under Fasciitis.

Browse Fasciitis studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

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

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
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)

Groups and cohorts

  • normal foot

    Subjects with normal foot structure

    Procedure: Foot orthosis, footwear

  • flat foot

    Subjects with flat foot structure.

    Procedure: Foot orthosis, Footwear

  • high arch foot

    Subjects with high arch foot structure.

    Procedure: Foot orthosis, footwear

Interventions

  • ProcedureFoot orthosis, footwear

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

    Also known as: Carbon fiber enhancement, Rocker sole shoe

  • ProcedureFoot orthosis, Footwear

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

    Also known as: Carbon fiber enhancement, Rocker sole shoe

  • ProcedureFoot orthosis, footwear

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

    Also known as: Carbon fiber enhancement, Rocker sole shoe

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 1 day

Secondary outcomes

  1. Foot MRI image, foot plantar soft tissue material property.

    Foot plantar soft tissue material property, such as elastic modulus(N/mm\^2).

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Chang Gung Memorial Hospital@ Taoyuan
    Taoyuan, 33342, Taiwan
    • Shih-Cherng Lin, Master · Contact · scherng@adm.cgmh.org.tw · +886-3-3196200
    • Chih-Chin Hsu, MD,PhD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 19744753 ↗
  • 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. PubMed 16425836 ↗
  • 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. PubMed 14970973 ↗
  • 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. PubMed 20646107 ↗
  • 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. PubMed 19617443 ↗
  • 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. PubMed 22884544 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01363375
Lead sponsor
Chang Gung Memorial Hospital
Collaborators
National Science Council, Taiwan
First posted
Jun 1, 2011
Start date
Jun 2009
Primary completion
Jul 2011 (estimated)
Completion
Jul 2011 (estimated)
Last update
Jun 1, 2011

Study contacts

Shih-Cherng Lin, Master
Contact
scherng@adm.cgmh.org.tw
+886-3-3281200 ext. 3846
Weng-Pin Chen, PhD
Contact
wpchen@mail.ntut.edu.tw
+-886-2-27212171 ext. 2082
Chih-Chin Hsu, MD, PhD
principal investigator · Chang Gung Memorial Hospital, Keelung

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion