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Therapeutic Effects of Customized Insoles on Children With Flat Foot

Primary Purpose

Flat Foot

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
ICB Medical insoles
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Flat Foot focused on measuring flat foot, therapeutic effect, insoles, children

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • flat foot

Exclusion Criteria:

  • age less than 3 years old or older than 10 years old
  • pathological flat foot

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

study group

control group

Arm Description

ICB Medical Insoles

without ICB Medical insoles

Outcomes

Primary Outcome Measures

health related quality of life (Pediatric Quality of Life Inventory (PedQoL)
Pediatric Quality of Life Inventory (PedQoL)

Secondary Outcome Measures

functional performance (Pediatric Outcome Data Collection Instrument)
Pediatric Outcome Data Collection Instrument

Full Information

First Posted
March 27, 2015
Last Updated
April 9, 2015
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02414087
Brief Title
Therapeutic Effects of Customized Insoles on Children With Flat Foot
Official Title
Therapeutic Effects of Customized Insoles on Children With Flat Foot
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flat Foot
Keywords
flat foot, therapeutic effect, insoles, children

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Active Comparator
Arm Description
ICB Medical Insoles
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
without ICB Medical insoles
Intervention Type
Device
Intervention Name(s)
ICB Medical insoles
Intervention Description
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
Primary Outcome Measure Information:
Title
health related quality of life (Pediatric Quality of Life Inventory (PedQoL)
Description
Pediatric Quality of Life Inventory (PedQoL)
Time Frame
baseline and up to 12 weeks
Secondary Outcome Measure Information:
Title
functional performance (Pediatric Outcome Data Collection Instrument)
Description
Pediatric Outcome Data Collection Instrument
Time Frame
baseline and up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: flat foot Exclusion Criteria: age less than 3 years old or older than 10 years old pathological flat foot
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Lan Hsieh, MD
Phone
886-2-28332211
Ext
2538
Email
M001052@ms.skh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ru-Lan Hsieh, MD
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
ZIP/Postal Code
111-01
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35080267
Citation
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.
Results Reference
derived
PubMed Identifier
35029841
Citation
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.
Results Reference
derived

Learn more about this trial

Therapeutic Effects of Customized Insoles on Children With Flat Foot

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