Validation of a quality of life assessment for spina bifida in Dutch
Official title: Validation of the Quality of Life Assessment in Spina Bifida for Children and Adolescents in Dutch
Run by Erasmus Medical Center · NCT06723951 · Data updated 2026-11-12
This study is testing a new questionnaire in Dutch to see how spina bifida affects the quality of life for children, teens, and adults with the condition compared to those without it.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 8 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 2 sites (Groningen and 1 other locations) |
| Status | Recruiting |
| Started | December 9, 2024 |
| Main results expected | February 28, 2025 |
| Study ends | March 31, 2025 |
| Registry record updated | December 12, 2024 |
| Trial ID | NCT06723951 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children aged 8-17 years and adults diagnosed with spina bifida who are fluent in Dutch.
✕Probably not a fit
Patients with neurogenic diseases other than spina bifida or those who have had recent surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to validate the Quality of Life Assessment for Spina Bifida (QUALAS) in Dutch for children, teenagers, and adults diagnosed with spina bifida. The study will involve a multicenter prospective validation cohort, comparing the quality of life of patients with spina bifida to a control group without the condition. The QUALAS questionnaires specifically address bladder and bowel dysfunction, which are significant factors affecting quality of life in these patients. By validating these assessments in Dutch, the study seeks to enhance the understanding of how spina bifida impacts patients' lives and improve clinical care.
Why it matters
Potential benefit: If successful, this study could provide a validated tool for assessing and improving the quality of life for patients with spina bifida.
How similar studies have gone: Previous studies have successfully validated similar quality of life assessments in other languages, indicating a promising approach for this validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Patient group: * Male or female patients aged 8 -12 years (QUALAS-C) * Male or female patients aged 13 - 17 years (QUALAS-T) * Adult patients (QUALAS-A) * Has spina bifida * Adult or child and at least one parent fluent in the Dutch language * Signed informed consent Control group: * Male or female children aged 8 -12 years (QUALAS-C) * Male or female adolescents aged 13 - 17 years (QUALAS-T) * Adults (QUALAS-A) * Has no spina bifida * Adult or child and at least one parent fluent in the Dutch language * Signed informed consent Exclusion Criteria: * Has a neurogenic disease other than spina bifida * Has had surgery in the last month
Where it's running
-
Erasmus MC
Rotterdam, Netherlands Recruiting -
Umcg
Groningen, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Lisette 't Hoen, MD, PhD — Erasmus Medical Center
- Study coordinator: Lisette 't Hoen, MD, PhD
- Email: l.thoen@erasmusmc.nl
- Phone: 0031107030073
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pediatric Manual Mobile Standing Wheelchair: Preliminary Utility
This study tests a new manual standing wheelchair for children aged 8-17 who use a manual chair and participate in standing programs to see if the device is practical and helpful.
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Psychosocial teleassistance programme for adults with spina bifida
This study tests a 10-week group telecare psychological program to see if it improves self-esteem, social skills, and overall psychological well-being in adults with spina bifida.
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Intravesical oxybutynin for children with neurogenic bladder due to spina bifida
We will test whether oxybutynin placed directly into the bladder helps children aged 6–17 with overactive neurogenic bladder from spina bifida.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.