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Customized Shoe-padding Orthotics for Plantar Fasciitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03226288
Recruitment Status : Unknown
Verified July 2017 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 21, 2017
Last Update Posted : July 25, 2017
The Industrial Technology Research Institute
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
While human body receives large external force or motions, minor injuries to the soft tissues will be produced and will lead to acute or chronic inflammation reactions. Plantar fasciitis is the most common foot diseases in normal population. Plantar fascia is a tight band-like soft tissue that crosses between the bony surfaces of the bottom of the foot with thick ligament-like structure substantially. Various reasons will induce the happening of plantar fasciitis including native bone structure, aging, athletic motions and injuries. Indeed, diagnosis of chronic heel pain remains challenging due to the complex structures of the foot. Therefore, it is widely accepted that diagnostic imaging such as ultrasound and computed tomography offer important orthopedic information for clinical assessments of soft tissues and bone. Even though there is no single treatment shows the highest level of evidence for plantar fasciitis, wearing of insoles or orthotics are highly suggested for clinical therapy. Common custom-made insoles are manufactured with polymeric materials based on standing foot-pressure distribution. However, this method strongly depends on experience of doctors or physical therapists and usually time-consuming. In addition, modern medical researches tend to combine the information of both soft (pressure distribution) and hard (orthopedic) tissues for designing of orthotics and other medical assistive devices because of the complicity of the limb motion and structures. Therefore, investigators aim at developing integrated 3D system that provides a 3D limb data model with high-resolution appearance scanning and orthopedic information for designing of medical assistant devices. This model composes of 3D surface scanning, 3D bony structure scanning, and soft tissues characteristic mechanical properties. By developing this system, the 3D model is also highly applicable to the other parts of human assistant devices. It will bring the enormous impact to the associated medical field and create excellent economic value.

Condition or disease
Plantar Fasciitis of Both Feet

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Integrated 3D Surface Scanning System Combined With Soft Tissue and Skeleton Information: Customized Shoe-padding Orthotics for Plantar Fasciitis
Actual Study Start Date : February 9, 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Primary Outcome Measures :
  1. Design customized shoe-padding orthotics for plantar fasciitis [ Time Frame: 3 months ]
    Combine the information of soft (pressure distribution) , hard (orthopedic) tissues and bone (CT) for designing of orthotics

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Experimental group: Plantar fasciitis patients recommended to use shoe-padding orthotics for treatment

Control group: Normal Adults (or without foot disease)


Inclusion Criteria:

  • 20-80 years old
  • Plantar fasciitis patients recommended to use shoe-padding orthotics for treatment

Exclusion Criteria:

  • Plantar fasciitis caused by specific reasons, eg. trauma, bone spur, Acute Bursitis.
  • Not Taiwanese

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03226288

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Contact: Wei-tung Kao +886-2-2312-3456 ext 65117

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NTUH East Campus, Research building, Room 946 Recruiting
Taipei, Taiwan, 10048
Contact: Wei-tung Kao    +886-2-2312-3456 ext 65117   
Sponsors and Collaborators
National Taiwan University Hospital
The Industrial Technology Research Institute
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Principal Investigator: Chih-Hao Mike Chang, PhD National Taiwan University Hospital

Additional Information:

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Responsible Party: National Taiwan University Hospital Identifier: NCT03226288     History of Changes
Other Study ID Numbers: 201704063RIND
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Plantar Fascitis
3D surface scanning

Additional relevant MeSH terms:
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Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases