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Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)

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ClinicalTrials.gov Identifier: NCT03060317
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Research Center of Neurology, Russia

Brief Summary:
The purpose of this study is to validate Russian version of Coma Recovery Scale - Revised and to assess its psychometric properties.

Condition or disease Intervention/treatment
Consciousness Disorders Behavioral: Examination with neurological scales.

Detailed Description:

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:

  1. Double direct translation by independent translators;
  2. Combination of two Russian translations;
  3. Reverse translation by native English speaker.

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.


Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : July 12, 2017
Actual Study Completion Date : July 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coma

Group/Cohort Intervention/treatment
Validation group DOC
Examination with neurological scales.
Behavioral: Examination with neurological scales.
Coma Recovery Scale, Glasgo Coma Scale, FOUR scale




Primary Outcome Measures :
  1. Coma Recovery Scale-Revised [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The group of patients will be selected from residents of Research Center of Neurology, Moscow, Russia and patients of Moscow municipal hospitals.
Criteria

Inclusion Criteria:

  • Adults recovering after coma in any period (persistent, permanent);
  • Vegetative state or minimal conscious state;
  • Locked-in syndrome.

Exclusion Criteria:

  • Coma, brain death.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03060317


Locations
Russian Federation
Research Center of Neurology
Moscow, Russian Federation, 125367
Sponsors and Collaborators
Research Center of Neurology, Russia
Investigators
Study Director: Michael A Piradov, PhD Research Center of Neurology, Moscow, Russia

Publications:
Responsible Party: Research Center of Neurology, Russia
ClinicalTrials.gov Identifier: NCT03060317     History of Changes
Other Study ID Numbers: RusvalidCRSR
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators examine the patients with 3 scales. These original protocols could be observed by the participants after a request.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Research Center of Neurology, Russia:
Disorders of consciousness
validation studies
coma
vegetative state

Additional relevant MeSH terms:
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders