Therapeutic Effects of Arch Support Insoles on Children

Not Applicable

Completed

• Conditions: Normal Development
• Interventions: Device: MEI BIN insoles

• Registration Number: NCT03198299
• Lead Sponsor: Taipei Medical University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-06
• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-22
• Last Update Submitted: 2017-06-22
• Study First Posted: 2017-06-26
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group: MEI BIN insoles	MEI BIN insoles	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.

Primary Outcome Measures

Name	Time	Method
change of baseline of up and go time to 12 weeks	baseline and up to 12 weeks	time of up and go
change of baseline of level walking time to 12 weeks	baseline and up to 12 weeks	time of level walking
change of baseline of stairs climbing time to 12 weeks	baseline and up to 12 weeks	time of stairs climbing
change of baseline of chair raising time to 12 weeks	baseline and up to 12 week	time of chair raising

Secondary Outcome Measures

Name	Time	Method
change of baseline functional performance(scores) to 12 weeks	baseline and up to 12 weeks	Pediatric Outcome Data Collection instrument
change of baseline balance (scores) to 12 weeks	baseline and up to 12 weeks	Berg balance test
change of baseline quality of life (scores) to 12 weeks	baseline and up to 12 weeks	Child Health Questionnaire-Parent form

Trial Locations

Locations (1)

Shin Kong Wu Ho-Su Memorial Hospital; 🇨🇳 Taipei, Taiwan