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Clinical Trials/NCT03198299
NCT03198299
Completed
N/A

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

Taipei Medical University1 site in 1 country45 target enrollmentJanuary 1, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Normal Development
Sponsor
Taipei Medical University
Enrollment
45
Locations
1
Primary Endpoint
change of baseline of level walking time to 12 weeks
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
December 31, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ru-Lan Hsieh

primary investigator

Taipei Medical University

Eligibility Criteria

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

Outcomes

Primary Outcomes

change of baseline of level walking time to 12 weeks

Time Frame: baseline and up to 12 weeks

time of level walking

change of baseline of stairs climbing time to 12 weeks

Time Frame: baseline and up to 12 weeks

time of stairs climbing

change of baseline of chair raising time to 12 weeks

Time Frame: baseline and up to 12 week

time of chair raising

change of baseline of up and go time to 12 weeks

Time Frame: baseline and up to 12 weeks

time of up and go

Secondary Outcomes

  • change of baseline functional performance(scores) to 12 weeks(baseline and up to 12 weeks)
  • change of baseline balance (scores) to 12 weeks(baseline and up to 12 weeks)
  • change of baseline quality of life (scores) to 12 weeks(baseline and up to 12 weeks)

Study Sites (1)

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