The Balance Influence of Shoe Inserts on Motor Development Delayed Children

Study Overview
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Brief Summary
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Flatfoot, one of the most common foot problems experienced by preschool-aged children, characterized by the collapse of the foot's medial longitudinal arch. Children with motor developmental delay often have flatfoot, according to clinical observation, and research indicates that preschool age is the main stage of the medial longitudinal arch development period. There flatfoot symptoms due to poor arch shock effect, poor walking endurance, likely to cause gait problems while growing up. The lack of a stable foot structure to support and maintain posture may lead to delayed motor development. Early training intervention and help to balance stability is the main rehabilitation goal for motor developmental delayed children. With understanding of the foot development of motor development delayed children, proper intervention can be provided to improve the movement and stability of the lower limbs. The possible deformation of the foot structure and resultant pain in the future can also be prevented.

Detailed Description
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The investigators designed a prospective cohort study to long-time follow up of preschool aged children with delayed motor development and to establish standard data, including the foot shape, footprint and balance development. The investigators also discuss the influence of the shoe insert with balance and flatfoot correction. Flatfoot leads to poor gross motor balance and the balance improvement after flatfoot correction has never been studied. The investigators findings should provide direct evidence as a reference for clinical workers.

Official Title
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Chung Shan Medical University Hospital Institutional Review Board

Conditions
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Development Delay

Intervention / Treatment
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* Device: Modified shoe inserts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preschool aged children with delayed motor development Exclusion Criteria: lower limb injury case in six months. other neurological history such as cerebral palsy, traumatic brain injury, spina bifida to cause of developmental delay. have been or are receiving insoles correction or treatment. can not be completed with the instruction by foot measurement and balance measurement.

Ages Eligible for Study
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Minimum Age: 36 Months
Maximum Age: 83 Months

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with modified shoe inserts<br>wear the modified shoe inserts and shoes for balance test. | Device: Modified shoe inserts<br>* For experimental arm: wear modified shoe inserts and shoes for balance test.<br>|
| No Intervention: without modified shoe inserts<br>only wear the shoes for balance test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The balance change of Movement ABC-2 scales | balance subscore of Movement ABC-2 scales | baseline/immediately/12 weeks/1 year/2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of foot print parameters | foot-print parameters(using CSI scales) | baseline/12 weeks/1 year/2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor development delay, balance, flatfoot, shoe insert