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
|Condition or disease||Intervention/treatment||Phase|
|Flexible Flatfoot||Device: Insole||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: customized insole group||
3D printing insole (Nylon), 3D printing insole (TPU), CNC machine insole (EVA), shoe only
- 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
- 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.
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
|Contact: Yuan-Hung Chao, Assistant email@example.com|
|Physical therapy center, national Taiwan university hosipital||Recruiting|
|Contact: Yuan-Hung Chao 886-2-33668129 firstname.lastname@example.org|