Therapeutic Effects of Arch Support Insoles on Children

Taipei Medical University

Status: Completed

Conditions: Normal Development

Treatments: Device: MEI BIN insoles

Study type: Interventional

Funder types: Other

Identifiers

NCT03198299

SKH-8302-105-DR-24

Details and patient eligibility

About

Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children

Full description

A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group).

All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group).

The control group were evaluated at baseline and up to 12 weeks.

Enrollment: 45 patients

Sex: All

Ages: 3 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks

Exclusion criteria

• age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

study group: MEI BIN insoles

Active Comparator group

Description:

Study group: participants in the study group were prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks.

Treatment:

Device: MEI BIN insoles

control group: without MEI BIN insoles

No Intervention group

Description:

Control group: participants in the control group were not prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks.