Validation Study of SCALA, Scale for Lateropulsion "SCALA"

Not yet recruiting

Phase N/A Results N/A

Trial Description

Development and clinical validation of SCALA, a new rating scale for lateropulsion after stroke. A monocentric controlled study including 60 patients post-stroke and 40 patients without stroke and/or healthy volunteers..
In order to analyze the SCALA's content validity, a Delphi-type consensus process will be applied prior to clinical validation. The Delphi process, including 20 international experts, will give rise to the version of the scale to be tested clinically.

Detailed Description

The protocol aims to develop and validate a new clinical rating scale assessing lateropulsion after stroke. The project is driven by the need to have a tool that better meets clinimetric properties than the 2 main existing scales, the Scale for Contraversive Pushing (SCP) and the Burke Lateropulsion Scale (BLS).
The initial version (version 0) of the scale has been developped by our team in Grenoble.
In a first step, an online expert consensus process (Delphi method) will give rise to a version 1, considered as generally accepted by the scientific community.
The SCALA version 1 will be validated in a monocentric clinical study. 60 patients and 40 patients without stroke and/or healthy controls will be included.

Conditions

Interventions

  • SCALA Device
    Intervention Desc: All items of SCALA are applied
    ARM 1: Kind: Experimental
    Label: stroke
    Description: stroke patients, application of SCALA
    ARM 2: Kind: Experimental
    Label: control
    Description: patients without stroke, application of SCALA

Trial Population

patients after stroke (up to 30d post-stroke)

Outcomes

Type Measure Time Frame Safety Issue
Primary Correlation of SCALA score with SCP-score at admission 60d
Secondary Evaluation of SCALA sensitivity 60d

Sponsors