An observational study in Disorder of Consciousness, sponsored by Fondazione Don Carlo Gnocchi Onlus. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Fondazione Don Carlo Gnocchi Onlus · Observational
The coma recovery scale-revised (CRS-R) is the recommended diagnostic scale for consciousness but it requires time, training, and provides total scores that do not always reflect the correct level of consciousness. Recently, a new short-term assessment tool for consciousness assessment has been validated, which could easily be implemented in daily practice to determine the level of consciousness in severely brain injured individuals: the simplified evaluation of consciousness disorders (SECONDs) .Its administration should be significantly shorter than CRS-R and accurate to allow monitoring of consciousness in the subacute / chronic phase. The SECONDs scale was constructed by selecting the items that, based on the latest scientific evidence, are most frequently associated with a minimally consciousness state. In fact, recent studies have shown that 5 items of the CRS-R allow to identify 99% of individuals with minimally consciousness state 1) reproducible movement on command, 2) visual pursuit 3) visual fixation 4) automatic motor response, and 5) localization to pain) 12. In addition, some changes have been introduced such as 1) the assessment of fixation and visual tracking through the use of the mirror 2) the use of autobiographical questions for the assessment of communication 3) the reduction of the number of orders on command to 2 of 3 instead of 3 out of 4 as in the CRS-R. All these changes have been made to minimize time for administration without compromising the accuracy of consciousness detection, to improve feasibility in clinical practice, and also to limit fatigue, which could produce better patient concentration and collaboration.
The aim of the multicentre study is to carry out a cross-cultural translation of the SECONDs assessment scale into Italian and to perform a validation between operators of different professions of the Italian version. validation will be conducted on a group of patients with prolunged disorders of consciousness in the subacute phase admitted to two units of severe acquired brain injuries of the don Carlo Gnocchi Foundation of Florence and Sant'Angelo dei Lombardi, and in the chronic phase IRCCS foundation Carlo Besta neurological institute
The first phase involves the Italian translation of the SECONDs scale through a rigorous multi-stage review and the drafting of the working and final versions. First, the original scale will undergo a forward translation into Italian by a certified translator. The Italian version obtained will then be discussed by the team of experts from the 3 centers participating in the study for transcultural adaptation. Then the revised Italian version will be subsequently back translated into the original language by another certified translator blinded from the original version. Any discrepancy will be thoroughly discussed between the interdisciplinary Italian group and with the external expert from the group that originally developed the scale, and the Italian version shall be re-defined, with the aim of determining the conceptual, semantic, and operational equivalence of the translated scale. (Phase 1) The second phase involves a pilot study in which the final Italian version of the identified scale will be administered to a small group of patients to determine its intra and interoperative validity (Phase 2A) Subsequently, the multicentre validation of the Italian scale is envisaged on a larger group of patients, 38 admitted to inpatient intensive rehabilitation in the subacute phase (don Gnocchi foundation) and 22 admitted to outpatient rehabilitation in the chronic phase (Istituto Besta) (Phase 2B).
236 studies on the registry are indexed under Consciousness Disorders; 102 are open to participants now.
This study's planned enrollment of 60 is below the median of 79 across 86 observational studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Fondazione Don Carlo Gnocchi Onlus is the lead sponsor of 146 studies on the registry; 37 are open to participants now.
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For the pilot intra and inter-rater validation study (Phase 2A), the enrollment of 10 consecutive patients (5 Florence, 2 Sant'Angelo and 3 Besta) is envisaged, subject to the signature of the informed consent of the legal representative.
For the second phase of multicentre validation, the recruitment of 60 consecutive or distributed patients is foreseen, Florence: 28; Sant'Angelo: 10 and Istituto Besta: 22.
Diagnosis of a disorder of consciousness
•> 28 days from the acute event
Exclusion Criteria:
The concurrent validity of the transcultural adaptation of the SECONDs scale with the CRS-R (correlation coefficient for Spearman's ranks)
The endpoint of the study is the creation of a valid and reliable transcultural adaptation of the SECONDs scale
Time frame: 21 months
the indexes of agreement between inter and intra examiners (index K)
The endpoint of the study is the creation of a valid and reliable transcultural adaptation of the SECONDs scale
Time frame: 21 months
Plan to share: Undecided
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Fondazione Don Carlo Gnocchi Onlus