Effects of Insoles on Children With Developmental Delays

Study Overview
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Brief Summary
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Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays

Detailed Description
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A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles). The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing. The control group will be evaluated at the baseline and up to 12 weeks.

Official Title
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Therapeutic Effects of Physical Function and Balance of Customized Insoles on Children With Developmental Delays

Conditions
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Developmental Delay

Intervention / Treatment
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* Device: MEI BIN insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: developmental delays Exclusion Criteria: age less than 3 years old or older than 10 years old normal development

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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No

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>Participants in the study group will be prescribed with a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks. | Device: MEI BIN insoles<br>* insoles<br>|
| No Intervention: control group: without MEI BIN insoles<br>Participants in this control group will not receive a pair of customized insoles (MEI BIN) 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 from baseline functional performance (scores) at 12 weeks | Pediatric Outcome Data Collection Instrument | baseline and up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline physical function (time) at 12 weeks | time of stair climbing, timed up and go, walking on level ground | baseline and up to 12 weeks | 
| change from baseline balance (scores) at 12 weeks | Berg balance scale | baseline and up to 12 weeks | 
| change from baseline quality of life at 12 weeks | Pediatric Quality of Life inventory (PedsQL) | 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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effect, insoles, children