Delayed;Development;PhysicalMDDNCT03130972
Etiology of Motor Developmental Delay in Children
An observational study of Delayed;Development;Physical and Delayed; Development, Intellectual, run by Bundang CHA Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delayed;Development;Physical, Delayed; Development, Intellectual
- How many people
- 1,355 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Children visiting tertiary hospital for motor developmental delay
Who may be able to join
- 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
Who cannot join
- single domain delay other than motor (e.g., speech delay)
About this study
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| developmental delay | Children who visited tertiary rehabilitation clinic for delayed motor development were all included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Gross Motor Function Classification System from baseline at 6 months
To avoid variation in each individual the exact date of evaluation for every outcome is included to estimate the exact time from birth
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Brain MRI findings
the first brain MRI taken after the event causative to developmental delay, read by radiology specialists
Measured: 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
BSID-II mental month estimated/actual age in month times 100
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study startJan 2009
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed;Development;PhysicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, M.D., Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130972
- Sponsor's protocol ID
- BD2015-129
- Acronym
- MDD
- Status last verified
- Apr 2017
- First submitted
- 15 Nov 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology of Motor Developmental Delay in Children
- ClinicalTrials.gov ID
- NCT03130972
- Acronym / sponsor ID
- MDD / BD2015-129
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,355 participants (actual)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| developmental delay | – | –Children who visited tertiary rehabilitation clinic for delayed motor development were all included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children visiting tertiary hospital for motor developmental delay
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- single domain delay other than motor (e.g., speech delay)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed;Development;Physical and Delayed; Development, Intellectual, run by Bundang CHA Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Gross Motor Function Classification System from baseline at 6 months (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.