Therapeutic Effects of Arch Support Insoles on Children

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 insoles on children

Detailed Description
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A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group). All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group). The control group were evaluated at baseline and up to 12 weeks.

Official Title
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Therapeutic Effects of Physical Function and Balance of Arch Support Insoles on Children

Conditions
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Normal Development

Intervention / Treatment
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* Device: MEI BIN insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks Exclusion Criteria: age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet

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: MEI BIN insoles<br>Study group: participants in the study group were prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks. | Device: MEI BIN insoles<br>* wearing insoles for 12 weeks<br>|
| No Intervention: control group: without MEI BIN insoles<br>Control group: participants in the control group were not prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of baseline of level walking time to 12 weeks | time of level walking | baseline and up to 12 weeks | 
| change of baseline of stairs climbing time to 12 weeks | time of stairs climbing | baseline and up to 12 weeks | 
| change of baseline of up and go time to 12 weeks | time of up and go | baseline and up to 12 weeks | 
| change of baseline of chair raising time to 12 weeks | time of chair raising | baseline and up to 12 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of baseline balance (scores) to 12 weeks | Berg balance test | baseline and up to 12 weeks | 
| change of baseline functional performance(scores) to 12 weeks | Pediatric Outcome Data Collection instrument | baseline and up to 12 weeks | 
| change of baseline quality of life (scores) to 12 weeks | Child Health Questionnaire-Parent form | 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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therapeutic effects, insoles, children