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Therapeutic Effects of Customized Insoles on Children With Flat Foot

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ClinicalTrials.gov Identifier: NCT02414087
Recruitment Status : Unknown
Verified April 2015 by Ru-Lan Hsieh, Taipei Medical University.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2015
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

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.

Condition or disease Intervention/treatment Phase
Flat Foot Device: ICB Medical insoles Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Therapeutic Effects of Customized Insoles on Children With Flat Foot
Study Start Date : April 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Active Comparator: study group
ICB Medical Insoles
Device: 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


Placebo Comparator: control group
without ICB Medical insoles



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. functional performance (Pediatric Outcome Data Collection Instrument) [ Time Frame: baseline and up to 12 weeks ]
    Pediatric Outcome Data Collection Instrument



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • flat foot

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414087


Contacts
Contact: Ru-Lan Hsieh, MD 886-2-28332211 ext 2538 M001052@ms.skh.org.tw

Locations
Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111-01
Sponsors and Collaborators
Taipei Medical University
Investigators
Principal Investigator: Ru-Lan Hsieh, MD Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University

Responsible Party: Ru-Lan Hsieh, Shin Kong Wu Ho-Su Memorial Hospital, Taipei Medical University
ClinicalTrials.gov Identifier: NCT02414087     History of Changes
Other Study ID Numbers: SKH-8302-104-DR-29
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Ru-Lan Hsieh, Taipei Medical University:
flat foot
therapeutic effect
insoles
children

Additional relevant MeSH terms:
Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities