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QUALAS Validation in Dutch

Recruitingn/aAges 8 Years - anyAllErasmus Medical Center
NCT06723951 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale Patients with spina bifida often experience a decreased quality of life compared to patients without spina bifida. The Quality of Life Assessment for Spina Bifida (QUALAS) is a validated questionnaire to assess the quality of life in children, teenagers and adults with spina bifida, accounting for specific factors, such as bladder and bowel dysfunction. This questionnaire enables us to assess the current spina bifida related quality of life and identify if bladder and bowel dysfunction is of influence. Objective(s) To validate the Quality of Life Assessment for Spina Bifida in Children, Teenagers and Adults in Dutch. Study type A multicenter prospective validation cohort study. Study population Children aged 8 - 17 years and adults who are diagnosed with spina bifida. As a control group children aged 8 - 17 years and adults without spina bifida will be approached at the Ear-

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📋 Eligibility rules (as published)
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
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What it tests

  • QUALAS survey
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Where

2 sites
UMCG
Groningen, Netherlands
Erasmus MC
Rotterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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