Motor Skills DisordersNCT06269796
Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder
An observational study of Motor Skills Disorders and Child Development, run by University of Thessaly at 1 site in Greece.
Trial summary
This prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Skills Disorders, Child Development, Child, Preschool
- What is being tested?
- Little Developmental Coordination Disorder Questionnaire (LDCDQ) and Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2)
- How many people
- 424 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2021to 30 Sep 2021
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preschool children aged 3-5 from 39 municipal kindergartens in Thessaloniki, Greece, who responded to the research invitation.
Who may be able to join
- Preschool children
- Aging from 3 to 5 years old
Who cannot join
- Diagnosis for medical conditions or mental retardation
Trial locations and contacts
1 site in 1 country.
Greece1 site
Human Performance & Rehabilitation Laboratory, Department of Physiotherapy, University of Thessaly
Lamia, Pthiotis, 35100
About this study
This prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. The Little DCDQ questionnaire and the BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency) were used for assessment.
- Conditions
- Motor Skills Disorders, Child Development, Child, Preschool
- Being tested
- Little Developmental Coordination Disorder Questionnaire (LDCDQ), Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2)
- Keywords
- Developmental Coordination Disorder (DCD), Little Developmental Coordination Disorder Questionnaire (Little DCDQ), Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Preschool Children
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Little Developmental Coordination Disorder Questionnaire (LDCDQ)Diagnostic test
The Little Developmental Coordination Disorder Questionnaire (LDCDQ) is a parent questionnaire consisting of 15 items designed to screen for motor coordination difficulties in 3- and 4-year-old children. It comprises 15 items grouped into two distinct factors: gross motor skills and fine motor skills. A Likert scale is used, ranging from one to five, where one (1) indicates "Not at all like your child" and five (5) indicates "Very much like your child". The total of the 15 items is added up to obtain a total score of 75.
Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2)Diagnostic test
The BOT-2 is standardized for children and adolescents aged 4 to 21 years and 11 months, and the full test takes 45 to 60 minutes to perform. The BOT-2 test was used to detect deviation from the norm and the likelihood of a diagnosis for DCD. The BOT-2 measures fine and gross motor proficiency, with subtests focusing on stability, mobility, strength, coordination, and object manipulation.
| Study group | Role | What they receive |
|---|---|---|
| Preschool Children | A prospective study was conducted, aiming at the early detection of neuromotor signs in preschool children with suspected Developmental Coordination Disorder (DCD) in Greece.The Little Developmental Coordination Disorder Questionnaire (LDCDQ) was used to evaluate motor skills of the children. Children with scores that indicated suspicion of DCD were offered the option to undergo the BOT-2 test. Receives: Diagnostic Test: Little Developmental Coordination Disorder Questionnaire (LDCDQ); Diagnostic Test: Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Screening Questionnaire for Motor Coordination Difficulties (DCD)
Little Developmental Coordination Disorder Questionnaire (LDCDQ); Unit of Measure: Likert Scale from 1 ("Not at all like your child") to 5 ("Very much like your child")
Measured: Complete Form - 10-15 minutes
Screening Test for Detection of Developmental Coordination Disorder (DCD)
Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2); Unit of Measure: ...
Measured: Complete Form - 45-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Mar 2021
- Primary completion31 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Skills DisordersStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Paras, University of Thessaly
- Investigators
- Ioannis Poulis, Prof, Study chair, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269796
- Sponsor's protocol ID
- little-dcdq
- Status last verified
- Apr 2024
- First submitted
- 13 Feb 2024
- Last updated
- 3 Apr 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 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder
- ClinicalTrials.gov ID
- NCT06269796
- Acronym / sponsor ID
- little-dcdq
- Conditions
- Motor Skills Disorders, Child Development, Child, Preschool
- Keywords
- Developmental Coordination Disorder (DCD), Little Developmental Coordination Disorder Questionnaire (Little DCDQ), Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), Preschool Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 21 Feb 2024 (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 prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. The Little DCDQ questionnaire and the BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency) were used for assessment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preschool Children | – | Diagnostic Test: Little Developmental Coordination Disorder Questionnaire (LDCDQ), Diagnostic Test: Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2)A prospective study was conducted, aiming at the early detection of neuromotor signs in preschool children with suspected Developmental Coordination Disorder (DCD) in Greece.The Little Developmental Coordination Disorder Questionnaire (LDCDQ) was used to evaluate motor skills of the children. Children with scores that indicated suspicion of DCD were offered the option to undergo the BOT-2 test. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preschool children aged 3-5 from 39 municipal kindergartens in Thessaloniki, Greece, who responded to the research invitation.
Key inclusion criteria (2 listed)
- Preschool children
- Aging from 3 to 5 years old
Key exclusion criteria (1 listed)
- Diagnosis for medical conditions or mental retardation
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 |
|---|---|---|
| Little Developmental Coordination Disorder Questionnaire (LDCDQ)The Little Developmental Coordination Disorder Questionnaire (LDCDQ) is a parent questionnaire consisting of 15 items designed to screen for motor coordination difficulties in 3- and 4-year-old children. It comprises 15 items grouped into two distinct factors: gross motor skills and fine motor skills. A Likert scale is used, ranging from one to five, where one (1) indicates "Not at all like your child" and five (5) indicates "Very much like your child". The total of the 15 items is added up to obtain a total score of 75. | Diagnostic test | Preschool Children |
| Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2)The BOT-2 is standardized for children and adolescents aged 4 to 21 years and 11 months, and the full test takes 45 to 60 minutes to perform. The BOT-2 test was used to detect deviation from the norm and the likelihood of a diagnosis for DCD. The BOT-2 measures fine and gross motor proficiency, with subtests focusing on stability, mobility, strength, coordination, and object manipulation. | Diagnostic test | Preschool Children |
Primary outcome
Parent Screening Questionnaire for Motor Coordination Difficulties (DCD)
Time frame: Complete Form - 10-15 minutes
Little Developmental Coordination Disorder Questionnaire (LDCDQ); Unit of Measure: Likert Scale from 1 ("Not at all like your child") to 5 ("Very much like your child")
Screening Test for Detection of Developmental Coordination Disorder (DCD)
Time frame: Complete Form - 45-60 minutes
Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition (BOT-2); Unit of Measure: ...
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 3 Apr 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.
Ioannis Poulis, Prof study chair
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Skills Disorders and Child Development, run by University of Thessaly at 1 site in Greece.
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 2 inclusion and 1 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 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Parent Screening Questionnaire for Motor Coordination Difficulties (DCD) (time frame: Complete Form - 10-15 minutes). The study lists 2 primary outcomes in all. 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 3 Apr 2024.