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Completed

NCT Number: NCT03126929

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

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).

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coma Recovery Scale-Revised and Glasgow Coma Scale

Diagnostic Test

Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hangzhou Normal University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 25, 2017
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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