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Validation Study of SCALA, Scale for Lateropulsion (SCALA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03077399
Recruitment Status : Not yet recruiting
First Posted : March 13, 2017
Last Update Posted : May 20, 2019
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 Phase
Stroke Device: SCALA Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
Experimental: stroke
stroke patients, application of SCALA
Device: SCALA
All items of SCALA are applied

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

Primary Outcome Measures :
  1. SCALA validation [ Time Frame: 60d ]
    Reliability and internal consistency of SCALA

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

Information from the National Library of Medicine

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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

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 identifier (NCT number): NCT03077399

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Contact: Dominic Pérennou, MD, PhD 0033 4 76767575
Contact: Andrea Kistner, PhD 0033 4 76767575

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

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Responsible Party: University Hospital, Grenoble Identifier: NCT03077399     History of Changes
Other Study ID Numbers: 38RC16.088
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
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:
Pusher syndrome
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases