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Completed

NCT Number: NCT03034590

How to Identify Fatigue in Stroke Patients

This study will translate an English case definition of poststroke fatigue and validate it against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale

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Key information

Conditions

Post Stroke Fatigue Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Herlev Hospital

Herlev, 2730, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with a clinical stroke within the last 6 months as judged by a senior doctor or by the research assistant.

Patients that have given written informed consent

-

Exclusion criteria

Patients with aphasia, dementia or cognitive deficits so severe that they are unable to understand the purpose of the interview and the questionnaire. -

Treatment and study plan

Questionnaire

Other

Primary outcomes

  1. Mean MFI-20 score for case positive patients

    Time frame: at inclusion in the trial

    Describes validity of the case definition with regards to the MFI-20 questionnaire

  2. Mean FSS-7 score for case positive patients

    Time frame: At inclusion in the trial

    Describes validity of the case definition with regards to the FSS-7 questionnaire

Secondary outcomes

  1. inter rater variability of the case definition

    Time frame: within a week

    Reinterview by a second interviewer

  2. Optimal cut off score for case positiveness on MFI-20 and FSS

    Time frame: at inclusion in the trial (which is the time the values used are measured)

    decide the optimal cut-off score on the two questionnaires to define case positiveness

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

How to Identify Fatigue in Stroke Patients: Validity of the Post-stroke Fatigue Case Definition

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 27, 2017
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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