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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03690843
Other study ID # B670201837290
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 8, 2018
Est. completion date January 6, 2023

Study information

Verified date December 2022
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to map the early development of children with DCD and compare it to typically developing (TD) children. At first we will investigate to what extent motor delay, reduced force, higher BMI, behavioral, ADL and participation problems occur in toddlerhood in DCD children and how this relates to TD children. We will also look into the evolution of these parameters in time (stability of development). Secondly we will explore if the diagnosis of DCD can be predicted using a standardized test before the age of five.


Description:

A longitudinal study design enables us to assess children at three different ages (3y, 4y and 5y). Assessment scores (AIMS or/and BSID) before the age of three will be retrieved retrospectively in the clinical group.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date January 6, 2023
Est. primary completion date January 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria DCD group: 1. The multidisciplinary team of the Center of Developmental Disabilities reports that the child has DCD or is at-risk for developing DCD and this at the age of 2 and/or 3 years. 2. At least one parent speaks Dutch to the child Inclusion Criteria controlgroup: 1. The child is three years of age at the moment of the first testing 2. Little-DCD-Q score = 55 at 3y 3. M-ABC-2 percentilescore =25 at 3y 4. No medical diagnoses possibly influencing the motor development (DCD, ADHD, ASS, CP,…) 5. No history of developmental motor stimulation (therapy) and/or support 6. Gestational age =37w 7. Birthweight =2500g 8. At least one parent speaks Dutch to the child

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Test Battery
All toddlers (DCD children + TD children) included in the study will be tested at three points in time, that is at the age of 3y, 4y and 5y with an extensive test battery. Questionnaires will be filled in by parents and teachers. Children will be tested using different instruments.

Locations

Country Name City State
Belgium Ghent University Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Developmental Coordination Disorder Presence or absence of a diagnosis of DCD as defined by the DSM-V diagnostic criteria. This will be assessed at the age of 5 years.
Secondary Movement Assessment Battery For children 2 - Dutch Version The M-ABC-2-NL is a motor assessment battery for children age 3 to 16y including three subtests (manual dexterity, ball skills and balance). The test battery was translated to Dutch and Dutch-Flemish norms are available. This will be assessed at the age of 3, 4 and 5 years.
Secondary Beery-Buktenica Developmental test of Visual-Motor Integration 6 The Beery-VMI-6 measures the visual-motor integration skills and consists of three subtests (visual-motor integration, motor coordination and visual perception). This will be assessed at the age of 3, 4 and 5 years.
Secondary Child Behaviour CheckList The CBCL consists of 120 items (3-pointscale) questioning the child's behavior. Two versions are available (teacher and parent) in two age-ranges (1.5y - 6y and 6y - 18y). The absence or presence of features of emotional disorder, anxiety disorder, AD(H)D, OCD, CD and somatic disorder are examined.
Both versions (parent + teacher) within the age-range 1.5 - 6y will be used.
This will be assessed at the age of 3, 4 and 5 years.
Secondary Functional Strength Measurement The FSM is a Dutch test assessing functional force in children 4 to 12y. The test consists of 8 items in two domains (upper extremity and lower extremity). Scores are presented either by limb (upper or lower limb) and/or by type of force (explosive power/endurance). This will be assessed at the age of 4 and 5 years.
Secondary Young Children's Participation and Environment Measure YC-PEM is a questionnaire for parents of children aged 0 to 6y. The test consists of 73 items on three participation scales (frequency, involvement and desire to change) and one environment scale (amount of support by environment) measured in three domains (home, kindergarden/school and community). This will be assessed at the age of 3, 4 and 5 years.
Secondary Little-DCD-Questionnaire The L-DCD-Q-NL originates in Israel and was designed for children 3 to 4y. It is a revision of the DCD-Q for older children. The Flemish translation expanded the age category from 3 to 5y. The L-DCD-Q is a parental questionnaire scoring 15 activities using a 5-point-Likert scale. This will be assessed at the age of 3, 4 and 5 years.
Secondary Motor Skills Checklist (VMVK) The VMVK is a Flemish teacher questionnaire consisting of 28 ADL-activities scored using a 4-point-scale. Norms are available for children age 3 to 5y. This will be assessed at the age of 3, 4 and 5 years.
Secondary DCD-Daily Questionnaire The DCD-Daily-Q is a Dutch parental questionnaire (5 - 8y) consisting of 23 ADL-activities (3-point scale) in three domains: how often the child participates (participation scale), how well the child performs (quality scale) and the time the child needs to learn new skills (learning scale). This will be assessed at the age of 5 years.
Secondary Body Mass Index Height and weight will be determined. This will be assessed at the age of 3, 4 and 5 years.
Secondary Social Communication Questionnaire SCQ is a parental screening questionnaire for autism in children aged 4 years or older. The questionnaire consists of 40 yes/no questions. This will be assessed at the age of 5 years.
Secondary Teacher report form The TRFconsists of 120 items (3-pointscale) questioning the child's behavior. Two versions are available (teacher and parent) in two age-ranges (1.5y - 6y and 6y - 18y). The absence or presence of features of emotional disorder, anxiety disorder, AD(H)D, OCD, CD and somatic disorder are examined. This will be assessed at the age of 3, 4 and 5 years.
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