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

Consciousness Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03060317
• Other study ID #: RusvalidCRSR
• Status: Completed
• Phase: N/A
• First received: February 4, 2017
• Last updated: July 17, 2017
• Start date: November 1, 2016
• Est. completion date: July 12, 2017

Study information

• Verified date: March 2017
• Source: Research Center of Neurology, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 12, 2017
• Est. primary completion date: July 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders

Intervention

Behavioral:
• Examination with neurological scales.
Coma Recovery Scale, Glasgo Coma Scale, FOUR scale

Locations

Country	Name	City	State
Russian Federation	Research Center of Neurology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Research Center of Neurology, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coma Recovery Scale-Revised		1 week