Validation of Czech Language Versions of Questionnaires for ALS Patients' Functional Status and Biomarker Long-term Follow-up

NCT06426030 | Recruiting

• 1 other identifier: VALID-ALS-QUEST-CZ
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis; ALS; ALSFRS-R; ALSFRS-EX; ALSAQ-40; Borg scale; Frontal assessment battery; Scale; Questionnaire

Outcome Measures

Primary Outcomes (3)

• Questionnaire validity (ALSFRS-R(-EX), ALSAQ-40, DYALS)

  Content Validity: Ensures the questionnaire comprehensively covers the construct it intends to measure.

  01.09.2024

• Questionnaire reproducibility (Czech versions of ALSFRS-R(-EX), ALSAQ-40, DYALS)

  Test-Retest Reliability: Intraclass Correlation Coefficient (ICC) Pearson or Spearman Correlation Coefficient Cohen's Kappa (κ) Bland-Altman Plot

  01.09.2024

• Agreement between self reported and non-self reported version of ALSFRS-R

  Test-Retest Reliability: Intraclass Correlation Coefficient (ICC) Pearson or Spearman Correlation Coefficient Cohen's Kappa (κ) Bland-Altman Plot

  01.09.2024

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ALS patients in colaborating Centres - University Hospital Brno (CZ), Motol University Hospital (CZ), Martin University Hospital (SK), University Hospital Bratislava (SK) - who are willing to participate in study.

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Masaryk University: lead
• Brno University Hospital: collaborator
• University Hospital, Motol: collaborator
• University Hospital, Martin: collaborator
• University Hospital Bratislava: collaborator

Study Sites (1)

University Hospital Brno

Brno, Czech Republic, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eva Vlckova, doc,MD,PhD

  Masaryk University, University Hospital Brno.

  STUDY CHAIR

Central Study Contacts

Adam Betik, MD

CONTACT

+420532232503; betik.adam@fnbrno.cz

Eva Vlckova, doc,MD,PhD

CONTACT

+420532233221; vlckova.eva@fnbrno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 23, 2024
• Study Start: May 17, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

CZ (1)