Validation of Czech questionnaires for ALS patients' functional status
Validation of Czech Language Versions of Questionnaires Most Frequently Used for Functional Status Monitoring in Patients With Amyotrophic Lateral Sclerosis and the Long-term Follow-up of Biomarkers of the Disease in These Patients.
This study is testing new Czech questionnaires to see how well they can help understand the daily life and well-being of people with ALS.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Masaryk University Academic / other |
| Locations | 1 site (Brno, Czech Republic) |
| Trial ID | NCT06426030 on ClinicalTrials.gov |
What this trial studies
This study aims to create and validate Czech language versions of several questionnaires designed to assess the functional status and quality of life of patients with amyotrophic lateral sclerosis (ALS). The questionnaires include the ALS Functional Rating Scale - Revised (ALSFRS-R), the extended version (ALSFRS-EX), the ALS Assessment Questionnaire (ALSAQ-40), and others. The validation process involves a forward-backward translation method and expert panel review to ensure accuracy and cultural relevance. Patients diagnosed with ALS will complete these questionnaires during routine clinical follow-ups and through follow-up telephone interviews to assess their reliability and effectiveness.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with amyotrophic lateral sclerosis who can comply with the study procedures.
Not a fit: Patients who do not have a diagnosis of amyotrophic lateral sclerosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide validated tools for better monitoring and individualized care for ALS patients in the Czech language.
How similar studies have performed: Similar validation studies in other languages have shown success, indicating that this approach is both tested and effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. diagnosed amyotrophic lateral sclerosis (ALS) meeting the EMG (electromyographic) criteria: * Gold Coast criteria or * at least clinically probable ALS according to Awaji-Shima criteria 2. willing and able to comply with all protocol procedures Exclusion Criteria: * none
Where this trial is running
Brno, Czech Republic
- University Hospital Brno — Brno, Czech Republic, Czechia (Recruiting)
Study contacts
- Study coordinator: Adam Betik, MD
- Email: betik.adam@fnbrno.cz
- Phone: +420532232503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.