NCT02414087

Therapeutic Effects of Customized Insoles on Children With Flat Foot

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Flat Foot

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-04-10
• Last updated: 2015-04-10

Locations

1 site across 1 country: Taiwan