Validation Study of SCALA, Scale for Lateropulsion (SCALA)
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|ClinicalTrials.gov Identifier: NCT03077399|
Recruitment Status : Not yet recruiting
First Posted : March 13, 2017
Last Update Posted : May 20, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: SCALA||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Validation of SCALA, a New Rating Scale for Assessing Lateropulsion After Stroke|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||December 2021|
stroke patients, application of SCALA
All items of SCALA are applied
patients without stroke, application of SCALA
All items of SCALA are applied
- SCALA validation [ Time Frame: 60d ]Reliability and internal consistency of SCALA
- Evaluation of SCALA sensitivity [ Time Frame: 60d ]application of Scale at different time ponts (from d30 to d90)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077399
|Contact: Dominic Pérennou, MD, PhD||0033 4 email@example.com|
|Contact: Andrea Kistner, PhD||0033 4 firstname.lastname@example.org|
|Grenoble University Hospital||Not yet recruiting|
|Contact: Dominic Pérennou, MD, PhD|
|Principal Investigator:||Dominic Pérennou||University Hospital, Grenoble|