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Validation Study of SCALA, Scale for Lateropulsion (SCALA)

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ClinicalTrials.gov Identifier: NCT03077399
Recruitment Status : Unknown
Verified March 2017 by University Hospital, Grenoble.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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
Stroke Device: SCALA

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of SCALA, a New Rating Scale for Assessing Lateropulsion After Stroke
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
stroke
stroke patients, application of SCALA
Device: SCALA
All items of SCALA are applied

control
patients without stroke, application of SCALA
Device: SCALA
All items of SCALA are applied




Primary Outcome Measures :
  1. Correlation of SCALA score with SCP-score at admission [ Time Frame: 60d ]
    Validity of SCALA versus actual gold standard (scale SCP)


Secondary Outcome Measures :
  1. Evaluation of SCALA sensitivity [ Time Frame: 60d ]
    application of Scale at different time ponts (from d30 to d90)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients after stroke (up to 30d post-stroke)
Criteria

Inclusion Criteria:

post stroke (<30d)

Exclusion Criteria:

neurological conditions interfering with balance acute vertigo postural asymmetry or scoliosis for reasons other than stroke


Information from the National Library of Medicine

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


Contacts
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Contact: Dominic Pérennou, MD, PhD 0033 4 76767575 akistner@chu-grenoble.fr
Contact: Andrea Kistner, PhD 0033 4 76767575 akistner@chu-grenoble.fr

Locations
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France
Grenoble University Hospital Not yet recruiting
Grenoble, France
Contact: Dominic Pérennou, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Dominic Pérennou University Hospital, Grenoble

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03077399     History of Changes
Other Study ID Numbers: 38RC16.088
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
lateropulsion
stroke
Pusher syndrome

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases