NCT03060317

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2017

Completed
Last Updated

July 19, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

February 4, 2017

Last Update Submit

July 17, 2017

Conditions

Consciousness Disorders

Keywords

Disorders of consciousnessvalidation studiescomavegetative state

Outcome Measures

Primary Outcomes (1)

  • Coma Recovery Scale-Revised

    1 week

Study Arms (1)

Validation group DOC

Examination with neurological scales.

Behavioral: Examination with neurological scales.

Interventions

Examination with neurological scales.BEHAVIORAL

Coma Recovery Scale, Glasgo Coma Scale, FOUR scale

Validation group DOC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adults recovering after coma in any period (persistent, permanent);
  • Vegetative state or minimal conscious state;
  • Locked-in syndrome.

You may not qualify if:

  • Coma, brain death.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center of Neurology

Moscow, 125367, Russia

Location

Related 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. doi: 10.1016/j.apmr.2004.02.033.

    PMID: 15605342BACKGROUND

MeSH Terms

Conditions

Consciousness DisordersComaPersistent Vegetative State

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersUnconsciousnessBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Michael A Piradov, PhD

    Research Center of Neurology, Moscow, Russia

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2017

First Posted

February 23, 2017

Study Start

November 1, 2016

Primary Completion

July 12, 2017

Study Completion

July 12, 2017

Last Updated

July 19, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

The investigators examine the patients with 3 scales. These original protocols could be observed by the participants after a request.

Locations

RU(1)