The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"

April 8, 2021 updated by: Esma Nur KOLBAŞI, Istanbul Medeniyet University
The Dyspnea-ALS-Scale (DALS-15) is a uni-dimensional scale to measure dyspnea in patients with Amyotrophic Lateral Sclerosis. It can be easily and rapidly applied. The aim of this study is to investigate reliability and validity of Turkish version of the DALS-15.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34700
        • Istanbul Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are diagnosed with Amyothrophic Lateral Sclerosis

Description

Inclusion Criteria:

  • Age of 18 or above
  • Dyspnea on exertion, dyspnea at rest, or orthopnea without evidence of pulmonary or cardiac causes of dyspnea

Exclusion Criteria:

  • Severe cognitive dysfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Dyspnea-ALS-Scale (DALS-15)
Time Frame: 10 minutes
The scale is used to measure dyspnea in ALS patients
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Borg Scale
Time Frame: 10 minutes
A 10 point Modified Borg Scale is used to assess dyspnea in supine and standing positions.
10 minutes
Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R)
Time Frame: 15 minutes
It is used to assess functional stats in ALS patients. This study particularly focus on pulmonary functions and dyspnea subscale of the scale.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Collaborators

Istanbul University
Istanbul University-Cerrahpasa

Investigators

  • Principal Investigator: ESMA NUR KOLBAŞI, MSc, Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 8, 2021

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (Actual)

March 12, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2021

Last Update Submitted That Met QC Criteria

April 8, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulMU4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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