Therapeutic Effects of Customized Insoles on Children With Flat Foot

Taipei Medical University

Status and phase: Unknown; Phase 4

Conditions: Flat Foot

Treatments: Device: ICB Medical insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT02414087

SKH-8302-104-DR-29

Details and patient eligibility

About

Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch-support shoe insoles to children with flat foot.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• flat foot

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

study group

Active Comparator group

Description:

ICB Medical Insoles

Treatment:

Device: ICB Medical insoles

control group

Placebo Comparator group

Description:

without ICB Medical insoles