Therapeutic Effects of Customized Insoles on Children With Flat Foot
NCT ID: NCT02414087
Last Updated: 2015-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
52 participants
INTERVENTIONAL
2015-04-30
2015-12-31
Brief Summary
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Detailed Description
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All participants in the insoles group will be evaluated at baseline, that is before the customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, balance, physical activity, functional performance, and quality of life will be re-evaluated up to 12 weeks after shoe insoles wearing in the insoles group.
The control group will be evaluated at the baseline and up to 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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study group
ICB Medical Insoles
ICB Medical insoles
Study group:
Participants in the study group will be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months.
Control group:
Participants in the control group will not be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months
control group
without ICB Medical insoles
No interventions assigned to this group
Interventions
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ICB Medical insoles
Study group:
Participants in the study group will be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months.
Control group:
Participants in the control group will not be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pathological flat foot
3 Years
10 Years
ALL
Yes
Sponsors
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Taipei Medical University
OTHER
Responsible Party
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Ru-Lan Hsieh
Shin Kong Wu Ho-Su Memorial Hospital
Principal Investigators
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Ru-Lan Hsieh, MD
Role: PRINCIPAL_INVESTIGATOR
Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
Locations
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Shin Kong Wu Ho-Su Memorial Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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References
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Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.
Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.
Other Identifiers
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SKH-8302-104-DR-29
Identifier Type: -
Identifier Source: org_study_id
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