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

Minimally Conscious State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126929
• Other study ID #: 2012/026/B
• Status: Completed
• Phase: N/A
• First received: April 17, 2017
• Last updated: April 21, 2017
• Start date: March 2012
• Est. completion date: March 2017

Study information

• Verified date: April 2017
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coma Recovery Scale-Revised for assess the level of consciousness	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)