Therapeutic Effects of Customized Insoles on Children With Flat Foot
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2015
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 10, 2015
April 1, 2015
8 months
March 27, 2015
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
health related quality of life (Pediatric Quality of Life Inventory (PedQoL)
Pediatric Quality of Life Inventory (PedQoL)
baseline and up to 12 weeks
Secondary Outcomes (1)
functional performance (Pediatric Outcome Data Collection Instrument)
baseline and up to 12 weeks
Study Arms (2)
study group
ACTIVE COMPARATORICB Medical Insoles
control group
PLACEBO COMPARATORwithout ICB Medical insoles
Interventions
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
Eligibility Criteria
You may qualify if:
- flat foot
You may not qualify if:
- age less than 3 years old or older than 10 years old
- pathological flat foot
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111-01, Taiwan
Related Publications (2)
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.
PMID: 35080267DERIVEDEvans 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.
PMID: 35029841DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ru-Lan Hsieh, MD
Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Shin Kong Wu Ho-Su Memorial Hospital
Study Record Dates
First Submitted
March 27, 2015
First Posted
April 10, 2015
Study Start
April 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 10, 2015
Record last verified: 2015-04