Customized Shoe-padding Orthotics for Plantar Fasciitis

July 23, 2017 updated by: National Taiwan University Hospital

Integrated 3D Surface Scanning System Combined With Soft Tissue and Skeleton Information: Customized Shoe-padding Orthotics for Plantar Fasciitis

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10048
        • Recruiting
        • NTUH East Campus, Research building, Room 946
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

The Industrial Technology Research Institute

Investigators

  • Principal Investigator: Chih-Hao Mike Chang, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2017

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 31, 2017

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 25, 2017

Last Update Submitted That Met QC Criteria

July 23, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201704063RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plantar Fasciitis of Both Feet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe