Effects of Insoles on Children With Developmental Delays

Developmental Delay Clinical Trial

Official title:

Therapeutic Effects of Physical Function and Balance of Customized Insoles on Children With Developmental Delays

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03191006
• Other study ID #: SKH-8302-106-DR-28.
• Status: Not yet recruiting
• Phase: N/A
• First received: June 11, 2017
• Last updated: June 22, 2017
• Start date: June 24, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2017
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: 228332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• developmental delays

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Developmental Delay

Intervention

Device:
• MEI BIN insoles
insoles

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Medical University	Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline functional performance (scores) at 12 weeks	Pediatric Outcome Data Collection Instrument	baseline and up to 12 weeks
Secondary	change from baseline physical function (time) at 12 weeks	time of stair climbing, timed up and go, walking on level ground	baseline and up to 12 weeks
Secondary	change from baseline balance (scores) at 12 weeks	Berg balance scale	baseline and up to 12 weeks
Secondary	change from baseline quality of life at 12 weeks	Pediatric Quality of Life inventory (PedsQL)	baseline and up to 12 weeks