Developmental Coordination DisorderNCT06311110
Impaired Toilet Training, LUTS and Bowel Dysfunction in Children With DCD
An observational study of Developmental Coordination Disorder and Lower Urinary Tract Symptoms, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
This cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, LUTS, and functional bowel problems among children diagnosed with DCD and typically developing children (TDC). Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder, Lower Urinary Tract Symptoms, Bowel Dysfunction
- What is being tested?
- Vancouver symptom score for dysfunctional elimination symptoms Questionnaire, Developmental Coordination Disorder Questionnaire and Questionnaire concerning impaired toilettraining and comorbities
- How many people
- 84 participants
- Where
- 2 sitesBelgium
- Study dates
- 14 Mar 2023to 1 Jun 2025
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with developmental coordination disorder and grade- and gender matched typically developing children.
Who may be able to join
- Diagnosed with DCD by a multidisciplinary team (DCD case group)
- Children with a typical development, grade and gender matched with the DCD case group (TDC control group).
Who cannot join
- A DCD-Q score indicative for DCD (TDC control group)
- Presence of other developmental disorders, such as ASS, ADHD or intellectual disability (TDC control group)
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Ghent University Hospital/Ghent University
Ghent, East Flanders, 9000
Bieke Samijn, Dr., +32 9 332 19 38, Bieke.Samijn@UGent.be
- Recruiting
University Hospital Ghent
Ghent
Bieke Samijn, +32 9 332 19 38, bieke.samijn@uzgent.be
About this study
Official title: Impaired Toilet Training, Lower Urinary Tract Symptoms and Bowel Dysfunction in Children With Developmental Coordination Disorder
This cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, LUTS, and functional bowel problems among children diagnosed with DCD and typically developing children (TDC).
- Being tested
- Vancouver symptom score for dysfunctional elimination symptoms Questionnaire, Developmental Coordination Disorder Questionnaire, Questionnaire concerning impaired toilettraining and comorbities
- Medical subject headings
- Motor Skills Disorders, Lower Urinary Tract Symptoms, Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancouver symptom score for dysfunctional elimination symptoms QuestionnaireOther
Also called VSSDES
Vancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016. The questionnaire is filled in by the parents of the child.
Developmental Coordination Disorder QuestionnaireOther
Also called DCD-Q, CVO
Validated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning. The questionnaire is filled in by the parents of the child.
Questionnaire concerning impaired toilettraining and comorbitiesOther
Unvalidated, complementary questions concerning impaired toilettraining and comorbidities. Questions were based on ICCS standardisation guidelines (Austin et al., 2015). The questionnaire is filled in by the parents of the child.
| Study group | Role | What they receive |
|---|---|---|
| DCD case group | The case group consists of children with developmental coordination disorder. Receives: Other: Vancouver symptom score for dysfunctional elimination symptoms Questionnaire; Other: Developmental Coordination Disorder Questionnaire; Other: Questionnaire concerning impaired toilettraining and comorbities | |
| TDC control group | The control group consists of typically developing children, grade and gender matched with the DCD case group. Receives: Other: Vancouver symptom score for dysfunctional elimination symptoms Questionnaire; Other: Developmental Coordination Disorder Questionnaire; Other: Questionnaire concerning impaired toilettraining and comorbities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impaired toilet training
Prevalence of impaired toilet training in children with DCD compared to TDC
Measured: through study completion, 25 minutes
Daytime incontinence
Prevalence of daytime incontinence at 5 years old in children with DCD compared to TDC
Measured: through study completion, 25 minutes
Enuresis
Prevalence of enuresis at 5 years old in children with DCD compared to TDC
Measured: through study completion, 25 minutes
Fecal incontinence
Prevalence of fecal incontinence at 4 years old in children with DCD compared to TDC
Measured: through study completion, 25 minutes
Secondary outcomes (2)
Toilet training difficulties
Prevalence and amount of toilet training difficulties in children with DCD compared to TDC
Measured: through study completion, 25 minutes
General bladder and bowel dysfunction
Prevalence of LUTS, bowel problems or combined bladder and bowel dysfunction in children with DCD compared to TDC
Measured: through study completion, 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start14 Mar 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
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 Hospital, 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
- Cross-sectional
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Vandamme, MD, Principal investigator, University Hospital, GhentBieke Samijn, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311110
- Sponsor's protocol ID
- #BC-11326 AM04
- Status last verified
- Aug 2024
- First submitted
- 7 Mar 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impaired Toilet Training, Lower Urinary Tract Symptoms and Bowel Dysfunction in Children With Developmental Coordination Disorder
- ClinicalTrials.gov ID
- NCT06311110
- Acronym / sponsor ID
- #BC-11326 AM04
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 15 Mar 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 cross-sectional case-control study aimed to determine whether there is a significant difference in the prevalence of impaired toilet training, LUTS, and functional bowel problems among children diagnosed with DCD and typically developing children (TDC).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCD case group | – | Other: Vancouver symptom score for dysfunctional elimination symptoms Questionnaire, Other: Developmental Coordination Disorder Questionnaire, Other: Questionnaire concerning impaired toilettraining and comorbitiesThe case group consists of children with developmental coordination disorder. |
| TDC control group | – | Other: Vancouver symptom score for dysfunctional elimination symptoms Questionnaire, Other: Developmental Coordination Disorder Questionnaire, Other: Questionnaire concerning impaired toilettraining and comorbitiesThe control group consists of typically developing children, grade and gender matched with the DCD case group. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with developmental coordination disorder and grade- and gender matched typically developing children.
Key inclusion criteria (2 listed)
- Diagnosed with DCD by a multidisciplinary team (DCD case group)
- Children with a typical development, grade and gender matched with the DCD case group (TDC control group).
Key exclusion criteria (2 listed)
- A DCD-Q score indicative for DCD (TDC control group)
- Presence of other developmental disorders, such as ASS, ADHD or intellectual disability (TDC control group)
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 |
|---|---|---|
| Vancouver symptom score for dysfunctional elimination symptoms QuestionnaireAlso: VSSDESVancouver symptom score for dysfunctional elimination syndrome, Dutch version, validated by 't Hoen et al. 2016. The questionnaire is filled in by the parents of the child. | Other | DCD case group, TDC control group |
| Developmental Coordination Disorder QuestionnaireAlso: DCD-Q, CVOValidated Developmental Coordination Disorder Questionnaire, Dutch version includes assessment of motor functioning. The questionnaire is filled in by the parents of the child. | Other | DCD case group, TDC control group |
| Questionnaire concerning impaired toilettraining and comorbitiesUnvalidated, complementary questions concerning impaired toilettraining and comorbidities. Questions were based on ICCS standardisation guidelines (Austin et al., 2015). The questionnaire is filled in by the parents of the child. | Other | DCD case group, TDC control group |
Primary outcome
Impaired toilet training
Time frame: through study completion, 25 minutes
Prevalence of impaired toilet training in children with DCD compared to TDC
Daytime incontinence
Time frame: through study completion, 25 minutes
Prevalence of daytime incontinence at 5 years old in children with DCD compared to TDC
Enuresis
Time frame: through study completion, 25 minutes
Prevalence of enuresis at 5 years old in children with DCD compared to TDC
Fecal incontinence
Time frame: through study completion, 25 minutes
Prevalence of fecal incontinence at 4 years old in children with DCD compared to TDC
2 secondary outcomes
Toilet training difficulties
Time frame: through study completion, 25 minutes
General bladder and bowel dysfunction
Time frame: through study completion, 25 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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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.
Ellen Vandamme, MD principal investigator
University Hospital, Ghent
Bieke Samijn, PhD principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Coordination Disorder and Lower Urinary Tract Symptoms, run by University Hospital, Ghent at 2 sites in Belgium.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Aug 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bieke Samijn, PhD (+32 9 332 19 38, bieke.samijn@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impaired toilet training (time frame: through study completion, 25 minutes). The study lists 4 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 2 Aug 2024.