Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R

April 21, 2017 updated by: Ying Zhang, Hangzhou Normal University

Further Psychometric Data for the Reliability and the Diagnostic Validity of the Coma Recovery Scale-Revised

This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recently, a report of the American Congress of Rehabilitation Medicine aiming to provide a systematic review of behavioral assessment scales for DOC has indicated that, when compared to other scales, the CRS-R meets the highest psychometric standards for the evaluation of severely brain-injured patients and may be used to assess DOC with minor reservations. However, that report mentions few evidences or studies with small sample sizes for some aspects of its reliability and validity such as its internal consistency and its test-retest reliability.The report also states that the diagnostic validity of the CRS-R remains unproven. In this study, the investigators will therefore aim to provide further psychometric data as regards those variables in a large sample of patients with DOC

Study Type

Observational

Enrollment (Actual)

169

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 86 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The investigators chosen patients with VS, MCS, EMCS

Description

Inclusion Criteria:

  • age above 18 years old
  • any etiology
  • pre-screening performed by the referent physician comforting the presence of a disorder of consciousness in accordance with international diagnostic criteria for VS, MCS or emergence from MCS (EMCS)

Exclusion Criteria:

  • neuromuscular blocking agents or sedative drugs administered within the prior 24 hours
  • no documented history of a prior coma
  • critical illness or unstable medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Vegetative state
patients lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R and GCS
Diagnostic test: Coma Recovery Scale-Revised and Glasgow Coma Scale
Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)
Minimally conscious state
Patients display inconsistent, but reproducible and discernible signs of awareness using CRS-R and GCS
Diagnostic test: Coma Recovery Scale-Revised and Glasgow Coma Scale
Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)
Emergence from MCS
Patients regain accurate communication and/or functional use of objects using CRS-R and GCS
Diagnostic test: Coma Recovery Scale-Revised and Glasgow Coma Scale
Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coma Recovery Scale-Revised for assess the level of consciousness
Time Frame: 24 hours(1 day)
Rater Measured the score of Coma Recovery Scale-Revised(CRS-R) within 24h. The CRS-R consists of 23 items grouped in six subscales addressing auditory, visual, motor, oromotor, communication and arousal functions. The lowest item on each subscale represents reflexive activity while the highest items represent cognitively-mediated behaviors.
24 hours(1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Normal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2012

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (ACTUAL)

April 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/026/B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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