NCT01363375

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

June 1, 2011

Status Verified

February 1, 2008

Enrollment Period

2.1 years

First QC Date

May 10, 2011

Last Update Submit

May 31, 2011

Conditions

Keywords

Plantar fasciaPlantar fasciitisFoot orthosisFinite element analysisGait analysisPlantar pressure measurement

Outcome Measures

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).

    1 day

Secondary Outcomes (1)

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

    1 day

Study Arms (3)

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

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

Also known as: Carbon fiber enhancement, Rocker sole shoe
normal foot

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • With normal bilateral foot arch structure, unilateral flat foot or unilateral high arch foot
  • With no more musculoskeletal disorders or malalignment
  • With no degeneration of low-extremity joint
  • With no diabetes mellitus or peripheral neuropathy
  • With no injury and pain of low-extremity in recent three month.

You may not qualify if:

  • Painful disorders
  • Foot related disorders or deformity
  • Dorsal or plantar wound and trauma
  • Poor proprioception
  • Obvious abnormal gait pattern, such as midfoot strike

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital@ Taoyuan

Taoyuan District, Taiwan, 33342, Taiwan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 19744753BACKGROUND
  • 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.

    PMID: 16425836BACKGROUND
  • 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.

    PMID: 14970973BACKGROUND
  • 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.

    PMID: 20646107BACKGROUND
  • 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.

    PMID: 19617443BACKGROUND
  • 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.

MeSH Terms

Conditions

FasciitisFasciitis, Plantar

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Chih-Chin Hsu, MD, PhD

    Chang Gung Memorial Hospital, Keelung

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shih-Cherng Lin, Master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2011

First Posted

June 1, 2011

Study Start

June 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

June 1, 2011

Record last verified: 2008-02

Locations