Therapeutic Effects of Customized Insoles on Children With Flat Foot

Flat Foot Clinical Trial

Official title:

Therapeutic Effects of Customized Insoles on Children With Flat Foot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02414087
• Other study ID #: SKH-8302-104-DR-29
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 27, 2015
• Last updated: April 9, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: 886-2-28332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• flat foot

Exclusion Criteria:

• age less than 3 years old or older than 10 years old

• pathological flat foot

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Flat Foot
• Flatfoot

Intervention

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

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	health related quality of life (Pediatric Quality of Life Inventory (PedQoL)	Pediatric Quality of Life Inventory (PedQoL)	baseline and up to 12 weeks	No
Secondary	functional performance (Pediatric Outcome Data Collection Instrument)	Pediatric Outcome Data Collection Instrument	baseline and up to 12 weeks	No