Developmental Coordination DisorderRVA_DCDNCT04126395
An Explorative RVA of the Motor Development of Children With DCD <2y
An observational study of Developmental Coordination Disorder and Autism Spectrum Disorder, run by University Ghent at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder, Autism Spectrum Disorder
- What is being tested?
- Movement Assessment Battery for Children 2(M-ABC-2), Developmental Coordination Disorder - Questionnaire (DCD-Q) and Social Responsiveness Scale 2 (SRS-2)
- How many people
- 49 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Sep 2020to 25 Jul 2023
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Community sample
Who may be able to join
- 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 )
- 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)
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- 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 )
Who cannot join
- 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:
- 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,...)
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- Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)
- DCD+ASD GROUP:
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Being tested
- Movement Assessment Battery for Children 2(M-ABC-2), Developmental Coordination Disorder - Questionnaire (DCD-Q), Social Responsiveness Scale 2 (SRS-2), Retrospective Video Analysis
- Keywords
- motor development, baby, infant, motor milestones, crawling, independent walking
- Medical subject headings
- Motor Skills Disorders, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement Assessment Battery for Children 2(M-ABC-2)Diagnostic test
The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age. We will use Dutch-Flemish norms.
Developmental Coordination Disorder - Questionnaire (DCD-Q)Diagnostic test
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.
Social Responsiveness Scale 2 (SRS-2)Diagnostic test
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 AnalysisOther
Retrospective video analysis will be used to explore motor development in children with DCD, DCD+ASD and controls.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2); Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q); Diagnostic Test: Social Responsiveness Scale 2 (SRS-2); Other: Retrospective Video Analysis | |
| 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) Receives: Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2); Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q); Diagnostic Test: Social Responsiveness Scale 2 (SRS-2); Other: Retrospective Video Analysis | |
| 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) Receives: Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2); Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q); Diagnostic Test: Social Responsiveness Scale 2 (SRS-2); Other: Retrospective Video Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observable Movement Quality Scale
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)
Measured: 0-2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start14 Sep 2020
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilde Van Waelvelde, Dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126395
- Sponsor's protocol ID
- BC-05716
- Acronym
- RVA_DCD
- Status last verified
- Feb 2024
- First submitted
- 11 Oct 2019
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Retrospective Video-analysis of the Motor Development of Children With Developmental Coordination Disorder Before the Age of Two
- ClinicalTrials.gov ID
- NCT04126395
- Acronym / sponsor ID
- RVA_DCD / BC-05716
- Keywords
- motor development, baby, infant, motor milestones, crawling, independent walking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 15 Oct 2019 (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 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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2), Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q), Diagnostic Test: Social Responsiveness Scale 2 (SRS-2), Other: Retrospective Video AnalysisThis 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) |
| Developmental Coordination Disorder | – | Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2), Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q), Diagnostic Test: Social Responsiveness Scale 2 (SRS-2), Other: Retrospective Video AnalysisThis groups consists of children now aged 6-12y: * With a multidisciplinary diagnosis of DCD * With motor problems (M-ABC-2 and DCD-Q) |
| Developmental Coordination Disorder + Autism Spectrum Disorder | – | Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2), Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q), Diagnostic Test: Social Responsiveness Scale 2 (SRS-2), Other: Retrospective Video AnalysisThis 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) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Community sample
Key inclusion criteria (10 listed)
- 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 )
- Availability of video material of the child before the age of 2.
- Formal diagnosis of DCD provided by multidisciplinary team in Flanders
Key exclusion criteria (11 listed)
- 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)
- 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,...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Controls, Developmental Coordination Disorder, Developmental Coordination Disorder + Autism Spectrum Disorder |
| 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 | Controls, Developmental Coordination Disorder, Developmental Coordination Disorder + Autism Spectrum Disorder |
| 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. | Diagnostic test | Controls, Developmental Coordination Disorder, Developmental Coordination Disorder + Autism Spectrum Disorder |
| Retrospective Video AnalysisRetrospective video analysis will be used to explore motor development in children with DCD, DCD+ASD and controls. | Other | Controls, Developmental Coordination Disorder, Developmental Coordination Disorder + Autism Spectrum Disorder |
Primary outcome
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)
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 22 Feb 2024.
- 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.
Hilde Van Waelvelde, Dr. principal investigator
University Ghent
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Coordination Disorder and Autism Spectrum Disorder, run by University Ghent at 2 sites in 2 countries.
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 10 inclusion and 11 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Observable Movement Quality Scale (time frame: 0-2years). 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 22 Feb 2024.