Effects of Insoles on Children With Developmental Delays

Not Applicable

• Conditions: Developmental Delay
• Interventions: Device: MEI BIN insoles

• Registration Number: NCT03191006
• Lead Sponsor: Taipei Medical University

Brief Summary

Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays

Detailed Description

A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles).

The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing.

The control group will be evaluated at the baseline and up to 12 weeks.

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-11
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-19
• Last Update Submitted: 2017-06-22
• Study Start: 2017-06-24
• Last Update Posted: 2017-06-26
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• developmental delays

Exclusion Criteria

• age less than 3 years old or older than 10 years old normal development

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group: MEI BIN insoles	MEI BIN insoles	Participants in the study group will be prescribed with a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
change from baseline functional performance (scores) at 12 weeks	baseline and up to 12 weeks	Pediatric Outcome Data Collection Instrument

Secondary Outcome Measures

Name	Time	Method
change from baseline balance (scores) at 12 weeks	baseline and up to 12 weeks	Berg balance scale
change from baseline physical function (time) at 12 weeks	baseline and up to 12 weeks	time of stair climbing, timed up and go, walking on level ground
change from baseline quality of life at 12 weeks	baseline and up to 12 weeks	Pediatric Quality of Life inventory (PedsQL)

Trial Locations

Locations (1)

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