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

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

Study Overview

• Status: Completed
• Conditions: Consciousness Disorders
• Intervention / Treatment: 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
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 125367
    • Research Center of Neurology

Participation Criteria

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

The group of patients will be selected from residents of Research Center of Neurology, Moscow, Russia and patients of Moscow municipal hospitals.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Coma Recovery Scale-Revised	1 week

Collaborators and Investigators

• Sponsor: Research Center of Neurology, Russia
• Investigators: Study Director: Michael A Piradov, PhD, Research Center of Neurology, Moscow, Russia

Publications and helpful links

General Publications

• Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): July 12, 2017
• Study Completion (Actual): July 12, 2017

Study Registration Dates

• First Submitted: February 4, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Disorders of consciousness; coma; vegetative state; validation studies
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Consciousness Disorders
• Other Study ID Numbers: RusvalidCRSR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The investigators examine the patients with 3 scales. These original protocols could be observed by the participants after a request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No