Therapeutic Effects of Customized Insoles on Children With Flat Foot

Study Overview
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Brief Summary
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Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch-support shoe insoles to children with flat foot.

Detailed Description
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A total of 52 children with flat foot will be collected. The participants will be randomized into two groups, including study group (insoles group) and control group (without insole group). 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.

Official Title
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Therapeutic Effects of Customized Insoles on Children With Flat Foot

Conditions
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Flat Foot

Intervention / Treatment
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* Device: ICB Medical insoles


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>ICB Medical Insoles | Device: ICB Medical insoles<br>* 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<br>|
| Placebo Comparator: control group<br>without ICB Medical insoles | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health related quality of life (Pediatric Quality of Life Inventory (PedQoL) | Pediatric Quality of Life Inventory (PedQoL) | baseline and up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional performance (Pediatric Outcome Data Collection Instrument) | Pediatric Outcome Data Collection Instrument | baseline and up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flat foot, therapeutic effect, insoles, children