Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)
NCT ID: NCT03060317
Last Updated: 2017-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2016-11-01
2017-07-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R
NCT03126929
Validity and Feasibility of the CRSR-FAST
NCT03549572
Target Behaviours to Identify Minimally Conscious State Patients
NCT04471753
Measuring Brain Complexity to Detect and Predict Recovery of Consciousness in the ICU
NCT06568536
The Efficacy of Familiar Voice Stimulation During Coma Recovery
NCT00557076
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Validation group DOC
Examination with neurological scales.
Examination with neurological scales.
Coma Recovery Scale, Glasgo Coma Scale, FOUR scale
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Examination with neurological scales.
Coma Recovery Scale, Glasgo Coma Scale, FOUR scale
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Vegetative state or minimal conscious state;
* Locked-in syndrome.
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Research Center of Neurology, Russia
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael A Piradov, PhD
Role: STUDY_DIRECTOR
Research Center of Neurology, Moscow, Russia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Center of Neurology
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RusvalidCRSR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.