An observational study in Consciousness Disorders, sponsored by Research Center of Neurology, Russia. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-19.
Sponsored by Research Center of Neurology, Russia · Observational
The purpose of this study is to validate Russian version of Coma Recovery Scale - Revised and to assess its psychometric properties.
There is a need of validated scale for correct assessment for patients with disorders of consciousness (DOC) in Russia. One of the most detailed scales that provides robust results in these patients is the Coma Recovery Scale - Revised (CRS-r). The validated Russian version of CRS-r will be very helpful in clinical work and scientific research for making correct assessment of patients status and its changes over time in Russia and Russian-speaking countries.
The purpose of this study is to validate Russian version of CRS-R and to assess its psychometric properties.
The first step of the study was to perform translation of CRS-r from English into Russian according to the validation protocol:
Final Russian version and back-translated version of the Scale were approved by the original author, Dr. J. Giacino. He approved the original validation study protocol as well.
To validate Russian version of CRS-r and to assess its psychometric properties the investigators will perform an observational study on 60 adults with disorders of consciousness of different etiology on different period of recovery after coma. It is planned to include patients with various states of consciousness (e.g., vegetative state, minimally conscious state "minus" and minimally conscious state "plus") in balanced proportions.
Every patient will be examined by two independent researchers on the same day. The patients will be examined twice with a week interval between examinations for evaluation of sensitivity of CRS-r. Test-retest reliability will be applied to investigate interrater reliability. This method will be applied as well to assess the consistency of patients' scores over time. The internal consistency of the test will be investigated by inter-rater method. For this item two researchers will conduct patient assessment with CRS-R on the same day with a small period of time between the examinations. Content validity of the test will be used for assessment of validity of CRS-R. It will be performed with expert evaluation of the content of CRS-R by the investigators. Сriterion validity will be examined by assessing the correlations of CRS-R with the scales of other questionnaires with proven high psychometric properties for consciousness disorders: the Glasgow Coma Scale and Full Outline of UnResponsiveness (FOUR) score.
236 studies on the registry are indexed under Consciousness Disorders; 102 are open to participants now.
This study's enrollment of 60 is below the median of 79 across 86 observational studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Research Center of Neurology, Russia is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The group of patients will be selected from residents of Research Center of Neurology, Moscow, Russia and patients of Moscow municipal hospitals.
Exclusion Criteria:
Examination with neurological scales.
Behavioral: Examination with neurological scales.
Coma Recovery Scale, Glasgo Coma Scale, FOUR scale
Coma Recovery Scale-Revised
Time frame: 1 week
Plan to share: Yes — The investigators examine the patients with 3 scales. These original protocols could be observed by the participants after a request.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Research Center of Neurology, Russia