Actively Recruiting
Validation of Czech Language Versions of Questionnaires for ALS Patients' Functional Status and Biomarker Long-term Follow-up
Led by Masaryk University · Updated on 2024-05-23
100
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
Sponsors
M
Masaryk University
Lead Sponsor
B
Brno University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Questionnaires and scales used to assess the clinical status and quality of life of patients with amyotrophic lateral sclerosis (ALS) are an important tool to monitor the disease progression and current needs of patients. The use of these tools (and in particular their combination) allows to cover the whole spectrum of potential patient difficulties and thus significantly facilitates the process of individualisation and optimisation of care. The aim of the study was to create and validate the Czech language versions of the following questionnaires or scales: (1) ALSFRS-R (ALS Functional Rating Scale - Revised Version) and (2) ALSFRS-EX (EXtended, i.e. extended, version of the same scale), both in the self-assessment version (incl. (3) the ALSAQ-40 (ALS Assessment Questionnaire including 40 questions), (4) the DYALS (Dysphagia in ALS), and (5) the Borg Dyspnoea Rating Scale. All questionnaires were translated using the forward-backward translation method. The scales and questionnaires were administered to ALS patients repeatedly at one-week intervals, first in writing during routine patient follow-up at the Neuromuscular Centre of the University Hospital Brno, and during repeated administrations by telephone.
CONDITIONS
Official Title
Validation of Czech Language Versions of Questionnaires for ALS Patients' Functional Status and Biomarker Long-term Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed amyotrophic lateral sclerosis meeting electromyographic criteria
- Diagnosis based on Gold Coast criteria or clinically probable ALS according to Awaji-Shima criteria
- Willing and able to comply with all study procedures
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Brno
Brno, Czech Republic, Czechia, 62500
Actively Recruiting
Research Team
A
Adam Betik, MD
CONTACT
E
Eva Vlckova, doc,MD,PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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