- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126395
An Explorative RVA of the Motor Development of Children With DCD <2y (RVA_DCD)
February 20, 2024 updated by: University Ghent
An Explorative Retrospective Video-analysis of the Motor Development of Children With Developmental Coordination Disorder Before the Age of Two
This study compares motor development in three groups of infants (controls, DCD, DCD+ASD) before the age of 2 years using retrospective video analysis of infants in home video contexts.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
49
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Amy De Roubaix, Drs.
- Phone Number: 003293326062
- Email: amy.deroubaix@ugent.be
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
6 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Community sample
Description
CONTROLS:
Inclusion Criteria:
- Availability of video material of the child before the age of 2.
- No indication of DCD (as measured by M-ABC-2 Pc>16 and DCD-Q)
- No indication of ASD (as measured by SRS-2 T-score ≤60 )
Exclusion Criteria:
- Medical diagnosis possibly influencing motor development (DCD, ASD, ADHD, CP, ect)
- Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
- Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)
DCD GROUP:
Inclusion criteria:
- Availability of video material of the child before the age of 2.
- Formal diagnosis of DCD provided by multidisciplinary team in Flanders
- Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)
Exclusion Criteria:
- Other medical diagnosis possibly influencing motor development (ASD, ADHD, CP, ect)
- Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
- Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)
DCD+ASD GROUP:
Inclusion criteria:
- Availability of video material of the child before the age of 2.
- Formal diagnosis of DCD and ASD provided by multidisciplinary team in Flanders
- Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)
- Indication of ASD (as measured by SRS-2 T-score >60 )
Exclusion Criteria:
- Other medical diagnosis possibly influencing motor development (ADHD, CP, ect.)
- Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
- Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)
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
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Controls
This groups consists of children now aged 6-12y:
|
The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age.
We will use Dutch-Flemish norms.
The DCD-Q is a brief parent questionnaire designed to screen for the presence of DCD in children aged 5 trough 15 years of age.
We will use Dutch norms.
The SRS-2 is a parent questionnaire designed to identify social impairments associated with ASD in children 4 trough 18 years of age.
We will used Dutch norms.
Retrospective video analysis will be used to explore motor development in children with DCD, DCD+ASD and controls.
|
Developmental Coordination Disorder + Autism Spectrum Disorder
This groups consists of children now aged 6-12y:
|
The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age.
We will use Dutch-Flemish norms.
The DCD-Q is a brief parent questionnaire designed to screen for the presence of DCD in children aged 5 trough 15 years of age.
We will use Dutch norms.
The SRS-2 is a parent questionnaire designed to identify social impairments associated with ASD in children 4 trough 18 years of age.
We will used Dutch norms.
Retrospective video analysis will be used to explore motor development in children with DCD, DCD+ASD and controls.
|
Developmental Coordination Disorder
This groups consists of children now aged 6-12y:
|
The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age.
We will use Dutch-Flemish norms.
The DCD-Q is a brief parent questionnaire designed to screen for the presence of DCD in children aged 5 trough 15 years of age.
We will use Dutch norms.
The SRS-2 is a parent questionnaire designed to identify social impairments associated with ASD in children 4 trough 18 years of age.
We will used Dutch norms.
Retrospective video analysis will be used to explore motor development in children with DCD, DCD+ASD and controls.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observable Movement Quality Scale
Time Frame: 0-2years
|
The OMQ is a standardized 15-item observational scale to asses the movement quality.
A maximum of two 5-minute compilations are assembled per child per age-category (6-12 months, 12-18 monhts, 18-24 months)
|
0-2years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hilde Van Waelvelde, Dr., University Ghent
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 (Actual)
September 14, 2020
Primary Completion (Actual)
July 25, 2023
Study Completion (Actual)
July 25, 2023
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
October 11, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-05716
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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