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

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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

Tracking Information
First Submitted Date  ICMJE May 5, 2020
First Posted Date  ICMJE May 8, 2020
Last Update Posted Date May 14, 2020
Actual Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2020)
  • Visual analogue scale [ Time Frame: after wearing insole (immediate effect) ]
    measure pain and wearing comfort (from 0 to 10 scores during sitting, standing and walking)
  • Foot function index [ Time Frame: after wearing each insole for a week (at least 6 hours per day) ]
    measure foot condition
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Customized Insoles on Biomechanics and Pain in Patients With Functional Flatfoot
Official Title  ICMJE The Effect of Customized Insoles on Biomechanics and Pain in Patients With Functional Flatfoot
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Flexible Flatfoot
Intervention  ICMJE Device: Insole
3D printing insole (Nylon), 3D printing insole (TPU), CNC machine insole (EVA), shoe only
Study Arms  ICMJE Experimental: customized insole group
Intervention: Device: Insole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2020)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yuan-Hung Chao, Assistant professor 886-0933121572 yuanhungchao@ntu.edu.tw
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04381039
Other Study ID Numbers  ICMJE 201909067DINA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP