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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 April 2015 |
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Main ID: |
NCT02414087 |
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Date of registration:
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27/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Therapeutic Effects of Customized Insoles on Children With Flat Foot
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Scientific title:
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Therapeutic Effects of Customized Insoles on Children With Flat Foot |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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52 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02414087 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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Phase 4
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Ru-Lan Hsieh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University |
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Name:
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Ru-Lan Hsieh, MD |
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Address:
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Telephone:
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886-2-28332211 |
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Email:
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M001052@ms.skh.org.tw |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- flat foot
Exclusion Criteria:
- age less than 3 years old or older than 10 years old
- pathological flat foot
Age minimum:
3 Years
Age maximum:
10 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Flat Foot
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Intervention(s)
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Device: ICB Medical insoles
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Primary Outcome(s)
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health related quality of life (Pediatric Quality of Life Inventory (PedQoL)
[Time Frame: baseline and up to 12 weeks]
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Secondary Outcome(s)
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functional performance (Pediatric Outcome Data Collection Instrument)
[Time Frame: baseline and up to 12 weeks]
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Secondary ID(s)
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SKH-8302-104-DR-29
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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