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History of Changes for Study: NCT03060317
Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)
Latest version (submitted July 17, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 21, 2017 None (earliest Version on record)
2 February 24, 2017 Contacts/Locations and Study Status
3 March 1, 2017 Contacts/Locations, Study Status and Study Description
4 July 17, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03060317
Submitted Date:  March 1, 2017 (v3)
Open or close this module Study Identification
Unique Protocol ID: RusvalidCRSR
Brief Title: Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)
Official Title: Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2017
Overall Status: Recruiting
Study Start: November 1, 2016
Primary Completion: June 2017 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: February 4, 2017
First Submitted that
Met QC Criteria:		 February 21, 2017
First Posted: February 23, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:		 March 1, 2017
Last Update Posted: March 3, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Research Center of Neurology, Russia
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The purpose of this study is to validate Russian version of Coma Recovery Scale - Revised and to assess its psychometric properties.
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.
Open or close this module Conditions
Conditions: Consciousness Disorders
Keywords: Disorders of consciousness
validation studies
coma
vegetative state
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Cross-Sectional
Biospecimen Retention:
Biospecimen Description:
Enrollment: 60 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Validation group DOC
Examination with neurological scales.
 Behavioral: Examination with neurological scales.
Coma Recovery Scale, Glasgo Coma Scale, FOUR scale
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Coma Recovery Scale-Revised
[ Time Frame: 1 week ]
Open or close this module Eligibility
Study Population: The group of patients will be selected from residents of Research Center of Neurology, Moscow, Russia and patients of Moscow municipal hospitals.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Elizaveta G Mochalova, MD
Telephone: +79670919870
Email: lizaveta.mochalova@gmail.com
Central Contact Backup: Natalia A Suponeva, PhD
Email: nasu2709@mail.ru
Study Officials: Michael A Piradov, PhD
Study Director
Research Center of Neurology, Moscow, Russia
Locations: Russian Federation
Research Center of Neurology
[Recruiting]
Moscow, Russian Federation, 125367
Contact:Contact: Elizaveta G. Mochalova, MD +70670919870 lizaveta.mochalova@gmail.com
Contact:Contact: Dmitry V. Sergeev, PhD dmsergeev@yandex.ru
Contact:Sub-Investigator: Yulia V. Ryabinkina, PhD
Contact:Sub-Investigator: Liudmila A. Legostaeva, MD
Contact:Sub-Investigator: Djamilya G. Yusupova, MD
Contact:Sub-Investigator: Maxim A. Domashenko, PhD
Open or close this module IPDSharing
Plan to Share IPD: Yes
The investigators examine the patients with 3 scales. These original protocols could be observed by the participants after a request.
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations: 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. PubMed 15605342
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