The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

Study Overview
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Brief Summary
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Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot.

Detailed Description
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Flexible flatfoot is a condition that involves the collapse of the medial longitudinal arch of the foot during weight-bearing stress and the restoration of the arch after the removal of body weight. Flatfoot may increase the load of the foot structure, potentially interfering with normal foot function. With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot, pain in the plantar foot, and instability of the medial foot structure. Treatment effect of corrective shoes or insoles on flexible flatfoot in children remain uncertain. In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.

Official Title
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The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

Conditions
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Flatfoot, Flexible

Intervention / Treatment
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* Device: arch insole and sham insole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children presenting symptomatic flexible flatfoot only Exclusion Criteria: Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: arch insole<br>Half of the subjects are randomly assigned to assess balance capacity with arch insole first. Three day wash out, the subjects are assess balance capacity with sham insole. | Device: arch insole and sham insole<br>* children wear insoles on feet<br>|
| Sham Comparator: sham insole<br>Half of the subjects are randomly assigned to assess balance capacity with sham insole first. Three day wash out, the subjects are assess balance capacity with arch insole. | Device: arch insole and sham insole<br>* children wear insoles on feet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Reach Test(FRT) from pre to post-intervention. | The Functional Reach Test (FRT) is a quick screen for determining balance capacity. | up to 10 minutes | 
| Pediatric Berg Balance Scale | Pediatric Berg Balance Scale was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. Maximum score is 56 ,and minimum values is 0. Score 54-56 means a better outcome. | up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Center of pressure (CoP) from pre to post-intervention. | The center of pressure (CoP) measures derived from the foot pressure mat and force plate of RSSCAN system. | up to 30 minutes |