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Clinical Trials/NCT02414087
NCT02414087
Unknown
Phase 4

Therapeutic Effects of Customized Insoles on Children With Flat Foot

Taipei Medical University1 site in 1 country52 target enrollmentApril 2015
ConditionsFlat Foot

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Flat Foot
Sponsor
Taipei Medical University
Enrollment
52
Locations
1
Primary Endpoint
health related quality of life (Pediatric Quality of Life Inventory (PedQoL)
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ru-Lan Hsieh

Shin Kong Wu Ho-Su Memorial Hospital

Taipei Medical University

Eligibility Criteria

Inclusion Criteria

  • flat foot

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: baseline and up to 12 weeks

Pediatric Quality of Life Inventory (PedQoL)

Secondary Outcomes

  • functional performance (Pediatric Outcome Data Collection Instrument)(baseline and up to 12 weeks)

Study Sites (1)

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