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An Explorative RVA of the Motor Development of Children With DCD <2y (RVA_DCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126395
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
VakgroepRevalidatiewetenschappen, University Ghent

Brief 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.

Condition or disease Intervention/treatment
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 Analysis

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: An Explorative Retrospective Video-analysis of the Motor Development of Children With Developmental Coordination Disorder Before the Age of Two
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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

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

  • With a multidisciplinary diagnosis of DCD
  • With motor problems (M-ABC-2 and DCD-Q)
  • Without 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 + 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.




Primary Outcome Measures :
  1. Early motor development [ Time Frame: 0-2years ]
    We will observe the motor development of infants in different positions (Prone, supine, sitting and standing position ect.) and during different motor activities (rolling over, crawling, standing up, walking independently ect).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

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)
  • No indication of ASD (as measured by SRS-2 T-score ≤60)

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126395


Contacts
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Contact: Amy De Roubaix, Drs. 003293326062 amy.deroubaix@ugent.be

Locations
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Belgium
Vakgroep Revalidatiewetenschappen Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Amy De Roubaix    003293326062    amy.deroubaix@ugent.be   
Contact: Hilde Van Waelvelde       hilde.vanwaelvelde@ugent.be   
Ghent University Recruiting
Ghent, Belgium, 9000
Contact: Amy De Roubaix       amy.deroubaix@ugent.be   
Principal Investigator: Amy De Roubaix, Drs.         
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Hilde Van Waelvelde, Dr. University Ghent
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Responsible Party: VakgroepRevalidatiewetenschappen, Prof. Dr. Hilde Van Waelvelde, University Ghent
ClinicalTrials.gov Identifier: NCT04126395    
Other Study ID Numbers: B670201941082
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VakgroepRevalidatiewetenschappen, University Ghent:
motor development
baby
infant
motor milestones
crawling
independent walking
Additional relevant MeSH terms:
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Disease
Autism Spectrum Disorder
Motor Skills Disorders
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders