Etiology of Motor Developmental Delay in Children (MDD)

April 24, 2017 updated by: MinYoung Kim, M.D., Bundang CHA Hospital
This study aims to identify the etiology of children with motor developmental delay, in association with the results of magnetic resonance imaging and genetic analysis.

Study Overview

Status

Completed

Conditions

Detailed Description

Results of other available assessments including Gross Motor Function Measurements and Bayley Scale of Infant Development, second edition, modified Ashworth Scale, IQ score and developmental language assessments are to be collected.

Study Type

Observational

Enrollment (Actual)

1355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children visiting tertiary hospital for motor developmental delay

Description

Inclusion Criteria:

  • clinical diagnosis of motor developmental delay
  • available results of functional assessments at ages older than 18 months Functional measures include either GMFM or BSID_II

Exclusion Criteria:

  • single domain delay other than motor (e.g., speech delay)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
developmental delay
Children who visited tertiary rehabilitation clinic for delayed motor development were all included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Gross Motor Function Classification System from baseline at 6 months
Time Frame: through study completion, an average of 1 year
To avoid variation in each individual the exact date of evaluation for every outcome is included to estimate the exact time from birth
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain MRI findings
Time Frame: From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months
the first brain MRI taken after the event causative to developmental delay, read by radiology specialists
From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months
Mental quotient
Time Frame: From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months
BSID-II mental month estimated/actual age in month times 100
From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bundang CHA Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • BD2015-129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Delayed;Development;Physical

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