Customized Shoe-padding Orthotics for Plantar Fasciitis

NCT ID: NCT03226288

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-09
• Study Completion Date: 2017-12-31

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.

Conditions

Plantar Fasciitis of Both Feet

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Industrial Technology Research Institute

OTHER

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chih-Hao Mike Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

NTUH East Campus, Research building, Room 946

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Wei-tung Kao

Role: CONTACT

toqi0715@gmail.com

+886-2-2312-3456 ext. 65117

Facility Contacts

Wei-tung Kao

Role: primary

toqi0715@gmail.com

+886-2-2312-3456 ext. 65117

Other Identifiers

201704063RIND

Identifier Type: -

Identifier Source: org_study_id