Therapeutic Effects of Customized Insoles on Children With Flat Foot

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02414087

Enrollment

Registered

2015-04-10

Start date

2015-04-30

Completion date

2015-12-31

Last updated

2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Flat Foot

Keywords

flat foot, therapeutic effect, insoles, children

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.

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.

Interventions

DEVICEICB 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 10 Years

Healthy volunteers

Yes

Inclusion criteria

* flat foot

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
health related quality of life (Pediatric Quality of Life Inventory (PedQoL)	baseline and up to 12 weeks	Pediatric Quality of Life Inventory (PedQoL)

Secondary

Measure	Time frame	Description
functional performance (Pediatric Outcome Data Collection Instrument)	baseline and up to 12 weeks	Pediatric Outcome Data Collection Instrument

Countries

Taiwan

Contacts

Primary ContactRu-Lan Hsieh, MD

M001052@ms.skh.org.tw886-2-28332211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026