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The Effect of Customized Insoles on Biomechanics and Pain in Patients With Functional Flatfoot

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04381039
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
The aim of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics

Condition or disease Intervention/treatment Phase
Flexible Flatfoot Device: Insole Not Applicable

Detailed Description:
Functional flatfoot is a common foot disease which induces pain and functional decline. Insoles can be used for intervention and correction, especially customized insoles which are made according to different foot types. There have been few studies using 3D printing for customized insoles for functional flatfoot. Besides, compared to traditional method and subtractive manufacturing, the effect of 3D printing customized insoles is still controversial and depends on technology, materials and design.The purpose of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics. Twelve patients with functional flatfoot (foot function index> 6) aged 20-65 years old will be recruited in this study. Participants plan to wear three kinds of customized insoles fabricated by 3D printing with Nylon and TPU or computer numerical control machine with EVA. F-Scan system and questionnaires will be used to record foot biomechanics and pain after wearing insoles immediately, and foot condition after three weeks. Statistical analysis will be adopted for repeated-measures analysis of variance (ANOVA) for all outcome measures and post-hoc test will be used to test the difference between groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Customized Insoles on Biomechanics and Pain in Patients With Functional Flatfoot
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : August 1, 2020

Arm Intervention/treatment
Experimental: customized insole group Device: Insole
3D printing insole (Nylon), 3D printing insole (TPU), CNC machine insole (EVA), shoe only




Primary Outcome Measures :
  1. F-scan system [ Time Frame: after wearing insole (immediate effect) ]
    measure peak plantar pressure, contact area, peak force and center of pressure excursion index during walking and center of pressure velocity and center of pressure 95% ellipse area during one leg stance by F-scan system


Secondary Outcome Measures :
  1. Visual analogue scale [ Time Frame: after wearing insole (immediate effect) ]
    This scale is used to measure pain and wearing comfort during sitting, standing and walking. For pain measurement, the maximum value is 10, which means severe pain. The minimum value is 0, which means absence of pain. For comfort measurement, the maximum value is 10, which means most comfortable. The minimum value is 0, which means absence of comfort.

  2. Foot function index [ Time Frame: after wearing each insole for a week (at least 6 hours per day) ]

    Foot function index is used to measure foot condition. It contains 23 items, which are divided into three subscales: activity limitation, disability, and pain.

    The patient scores each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.

    Higher scores indicates worse pain. Both total and subcategory scores are calculated.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged between 20 and 65 years old
  • Appearance of decreased medial arch
  • Foot posture index score between 6 to 12

Exclusion Criteria:

  • History of injuries of the lower extremity within the past 6 months
  • Experience of use of orthopedic insole within the past 6 months
  • Acute disorders in the lower extremities and spine
  • History of surgery on the lower extremities and lumbar spine within the past 6 months

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 ClinicalTrials.gov identifier (NCT number): NCT04381039


Contacts
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Contact: Yuan-Hung Chao, Assistant professor 886-0933121572 yuanhungchao@ntu.edu.tw

Locations
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Taiwan
Physical therapy center, national Taiwan university hosipital Recruiting
Taipei, Taiwan
Contact: Yuan-Hung Chao    886-2-33668129    yuanhungchao@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04381039    
Other Study ID Numbers: 201909067DINA
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities