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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04305639
Other study ID # IstanbulMU4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date April 8, 2021

Study information

Verified date April 2021
Source Istanbul Medeniyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date April 8, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Locations

Country Name City State
Turkey Istanbul Faculty of Medicine Istanbul

Sponsors (3)

Lead Sponsor Collaborator
Istanbul Medeniyet University Istanbul University, Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Dyspnea-ALS-Scale (DALS-15) The scale is used to measure dyspnea in ALS patients 10 minutes
Secondary Modified Borg Scale A 10 point Modified Borg Scale is used to assess dyspnea in supine and standing positions. 10 minutes
Secondary Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) 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
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