Clinical trial NCT03226288: Customized Shoe-padding Orthotics for Plantar Fasciitis
Official title: Integrated 3D Surface Scanning System Combined With Soft Tissue and Skeleton Information: Customized Shoe-padding Orthotics for Plantar Fasciitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Plantar Fasciitis of Both Feet
Keywords: Plantar Fascitis
orthopedic
3D surface scanning
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: The Industrial Technology Research Institute
First posted: 2017-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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)

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.


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

Primary outcomes:
measure: Design customized shoe-padding orthotics for plantar fasciitis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH East Campus, Research building, Room 946
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Hao Mike Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: