Therapeutic Effects of Arch Support Insoles on Children

June 22, 2017 updated by: Ru-Lan Hsieh, Taipei Medical University

Therapeutic Effects of Physical Function and Balance of Arch Support Insoles on Children

Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group).

All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group).

The control group were evaluated at baseline and up to 12 weeks.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 111-01
        • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks

Exclusion Criteria:

  • age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: study group: MEI BIN insoles
Study group: participants in the study group were prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks.
Device: MEI BIN insoles
wearing insoles for 12 weeks
No Intervention: control group: without MEI BIN insoles
Control group: participants in the control group were not prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of baseline of level walking time to 12 weeks
Time Frame: baseline and up to 12 weeks
time of level walking
baseline and up to 12 weeks
change of baseline of stairs climbing time to 12 weeks
Time Frame: baseline and up to 12 weeks
time of stairs climbing
baseline and up to 12 weeks
change of baseline of up and go time to 12 weeks
Time Frame: baseline and up to 12 weeks
time of up and go
baseline and up to 12 weeks
change of baseline of chair raising time to 12 weeks
Time Frame: baseline and up to 12 week
time of chair raising
baseline and up to 12 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of baseline balance (scores) to 12 weeks
Time Frame: baseline and up to 12 weeks
Berg balance test
baseline and up to 12 weeks
change of baseline functional performance(scores) to 12 weeks
Time Frame: baseline and up to 12 weeks
Pediatric Outcome Data Collection instrument
baseline and up to 12 weeks
change of baseline quality of life (scores) to 12 weeks
Time Frame: baseline and up to 12 weeks
Child Health Questionnaire-Parent form
baseline and up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

June 13, 2017

First Submitted That Met QC Criteria

June 22, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SKH-8302-105-DR-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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