Therapeutic Effects of Customized Insoles on Children With Flat Foot

NCT ID: NCT02414087

Last Updated: 2015-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

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.

Conditions

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Flat Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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study group

ICB Medical Insoles

Group Type ACTIVE_COMPARATOR

ICB Medical insoles

Intervention Type DEVICE

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

control group

without ICB Medical insoles

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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ICB Medical insoles

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

Intervention Type DEVICE

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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ru-Lan Hsieh

Shin Kong Wu Ho-Su Memorial Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ru-Lan Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Ru-Lan Hsieh, MD

Role: CONTACT

886-2-28332211 ext. 2538

References

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Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub4.

Reference Type DERIVED
PMID: 35080267 (View on PubMed)

Evans AM, Rome K, Carroll M, Hawke F. Foot orthoses for treating paediatric flat feet. Cochrane Database Syst Rev. 2022 Jan 14;1(1):CD006311. doi: 10.1002/14651858.CD006311.pub3.

Reference Type DERIVED
PMID: 35029841 (View on PubMed)

Other Identifiers

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SKH-8302-104-DR-29

Identifier Type: -

Identifier Source: org_study_id

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