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.

Status: Recruiting
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• diagnosed amyotrophic lateral sclerosis (ALS) meeting the EMG (electromyographic) criteria:

‣ Gold Coast criteria or

⁃ at least clinically probable ALS according to Awaji-Shima criteria

• willing and able to comply with all protocol procedures

Contact Information
Primary
Adam Betik, MD
betik.adam@fnbrno.cz
+420532232503
Backup
Eva Vlckova, doc,MD,PhD
vlckova.eva@fnbrno.cz
+420532233221
Time Frame
Start Date: 2024-05-17
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 100
Sponsors
Collaborators: University Hospital Bratislava, Brno University Hospital, University Hospital, Motol, University Hospital, Martin
Leads: Masaryk University

This content was sourced from clinicaltrials.gov