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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University
  • Canada
      • Vancouver, Canada
        • UBC

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Controls

This groups consists of children now aged 6-12y:

  • Without a medical diagnosis possibly influencing motor development
  • Without motor problems (M-ABC-2 and DCD-Q)
  • Without social reponsiveness problems (SRS-2)
Diagnostic test: Movement Assessment Battery for Children 2(M-ABC-2)
The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age. We will use Dutch-Flemish norms.
Diagnostic test: Developmental Coordination Disorder - Questionnaire (DCD-Q)
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.
Diagnostic test: Social Responsiveness Scale 2 (SRS-2)
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.
Other: Retrospective Video Analysis
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:

  • With a multidisciplinary diagnosis of DCD
  • With motor problems (M-ABC-2 and DCD-Q)
  • With social responsiveness problems (SRS-2)
Diagnostic test: Movement Assessment Battery for Children 2(M-ABC-2)
The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age. We will use Dutch-Flemish norms.
Diagnostic test: Developmental Coordination Disorder - Questionnaire (DCD-Q)
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.
Diagnostic test: Social Responsiveness Scale 2 (SRS-2)
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.
Other: Retrospective Video Analysis
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:

  • With a multidisciplinary diagnosis of DCD
  • With motor problems (M-ABC-2 and DCD-Q)
Diagnostic test: Movement Assessment Battery for Children 2(M-ABC-2)
The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age. We will use Dutch-Flemish norms.
Diagnostic test: Developmental Coordination Disorder - Questionnaire (DCD-Q)
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.
Diagnostic test: Social Responsiveness Scale 2 (SRS-2)
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.
Other: Retrospective Video Analysis
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ghent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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