Consciousness DisordersNCT03060317
Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)
An observational study of Consciousness Disorders, run by Research Center of Neurology, Russia at 1 site in Russia.
Trial summary
The purpose of this study is to validate Russian version of Coma Recovery Scale - Revised and to assess its psychometric properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consciousness Disorders
- What is being tested?
- Examination with neurological scales.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 1 Nov 2016to 12 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The group of patients will be selected from residents of Research Center of Neurology, Moscow, Russia and patients of Moscow municipal hospitals.
Who may be able to join
- Adults recovering after coma in any period (persistent, permanent);
- Vegetative state or minimal conscious state;
- Locked-in syndrome.
Who cannot join
- Coma, brain death.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to validate Russian version of Coma Recovery Scale - Revised and to assess its psychometric properties.
Read the 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:
- Double direct translation by independent translators;
- Combination of two Russian translations;
- 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
- Consciousness Disorders
- Being tested
- Examination with neurological scales.
- Keywords
- Disorders of consciousness, validation studies, coma, vegetative state
- Medical subject headings
- Consciousness Disorders, Coma, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination with neurological scales.Behavioural
Coma Recovery Scale, Glasgo Coma Scale, FOUR scale
| Study group | Role | What they receive |
|---|---|---|
| Validation group DOC | Examination with neurological scales. Receives: Behavioral: Examination with neurological scales. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale-Revised
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start1 Nov 2016
- Primary completion12 Jul 2017
- Study completion12 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Consciousness DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Center of Neurology, Russia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michael A Piradov, PhD, Study director, Research Center of Neurology, Moscow, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03060317
- Sponsor's protocol ID
- RusvalidCRSR
- Status last verified
- Mar 2017
- First submitted
- 4 Feb 2017
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators examine the patients with 3 scales. These original protocols could be observed by the participants after a request.
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.
PubMed 15605342
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Russian Version of Coma Recovery Scale-Revised (CRS-R)
- ClinicalTrials.gov ID
- NCT03060317
- Acronym / sponsor ID
- RusvalidCRSR
- Conditions
- Consciousness Disorders
- Keywords
- Disorders of consciousness, validation studies, coma, vegetative state
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Research Center of Neurology, RussiaOther government
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 12 Jul 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Double direct translation by independent translators;
- Combination of two Russian translations;
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation group DOC | – | Behavioral: Examination with neurological scales.Examination with neurological scales. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The group of patients will be selected from residents of Research Center of Neurology, Moscow, Russia and patients of Moscow municipal hospitals.
Key inclusion criteria (3 listed)
- Adults recovering after coma in any period (persistent, permanent);
- Vegetative state or minimal conscious state;
- Locked-in syndrome.
Key exclusion criteria (1 listed)
- Coma, brain death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Examination with neurological scales.Coma Recovery Scale, Glasgo Coma Scale, FOUR scale | Behavioural | Validation group DOC |
Primary outcome
Coma Recovery Scale-Revised
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Background: PubMed 15605342Giacino 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.
- Individual participant dataSharing planned: Yes. The investigators examine the patients with 3 scales. These original protocols could be observed by the participants after a request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Piradov, PhD study director
Research Center of Neurology, Moscow, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consciousness Disorders, run by Research Center of Neurology, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale-Revised (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03060317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.