Viewing Study NCT03191006


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Study NCT ID: NCT03191006
Status: UNKNOWN
Last Update Posted: 2017-06-26
First Post: 2017-06-11
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Effects of Insoles on Children With Developmental Delays
Sponsor: Taipei Medical University
Organization:

Study Overview

Official Title: Therapeutic Effects of Physical Function and Balance of Customized Insoles on Children With Developmental Delays
Status: UNKNOWN
Status Verified Date: 2017-06
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: